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Get filing alertsrevenue $25.3B, net income $5.53B. J&J Q2 FY26: Revenue +6.6% on oncology strength; biosimilar/generic headwinds intensify
Filed July 23, 2026 · Period ending June 28, 2026 · Compared to 10-Q Jul 24, 2025 · ~2 min read
Key Financials
SEC XBRL| Metric | PriorJun 29, 2025 | CurrentJun 28, 2026 | Δ |
|---|---|---|---|
| Revenue | $23.7B | $25.3B | ▲ +6.6% |
| Net income | $5.54B | $5.53B | ▼ -0.1% |
| Diluted EPS | $2.29 | $2.27 | ▼ -0.9% |
| Cash & equivalents | $18.6B | $20.4B | ▲ +9.9% |
| Long-term debt (noncurrent) | $39.2B | $37.3B | ▼ -4.8% |
| Total assets | $193.4B | $201.1B | ▲ +4.0% |
As reported in XBRL by the filer · 10-Q vs 10-Q. Income figures cover the fiscal quarter (not year-to-date); cash & assets are period-end balances. n/m = not meaningful (sign change; a % would mislead). about this table · verify on EDGAR →
Key Number Changes
Prior filing · verify on EDGAR →
During the fiscal second quarter of 2025, the Company did not repurchase any shares of Johnson & Johnson Common Stock in open-market transactions.
Current filing · verify on EDGAR →
During the fiscal second quarter of 2026, the Company repurchased an aggregate of 970,250 shares of Johnson & Johnson Common Stock in open-market transactions, all of which were purchased as part of a systematic plan to meet the needs of the Company’s compensation programs.
Prior filing · verify on EDGAR →
Body powders containing talc, primarily JOHNSON’S Baby Powder 70,030
Current filing · verify on EDGAR →
As of June 28, 2026, there are approximately 76,000 plaintiffs in the United States with direct claims against the Company and its affiliates in pending lawsuits regarding injuries allegedly due to the use of body powders containing talc, primarily JOHNSON’S Baby Powder.
Prior filing · verify on EDGAR →
As of the second quarter 2025, the total present value of the reserve is approximately $4.0 billion, comprising previously executed settlement agreements, litigation defense and other costs. Approximately one-third of the reserve is recorded as a current liability.
Current filing · verify on EDGAR →
As of the second quarter of 2026, the total present value of the reserve for talc related matters is approximately $3.7 billion, comprising executed settlement agreements, litigation defense and other costs. Approximately 40% of the reserve is recorded as a current liability.
Prior filing · verify on EDGAR →
For the fiscal six months of 2025, worldwide sales were $45.6 billion, a total increase of 4.1%, including an operational* increase of 4.4% as compared to 2024 fiscal six months sales of $43.8 billion.
Current filing · verify on EDGAR →
For the fiscal six months of 2026, worldwide sales were $49.4 billion, a total increase of 8.2%, including an operational* increase of 6.0% as compared to 2025 fiscal six months sales of $45.6 billion.
Prior filing · verify on EDGAR →
In the fiscal six months of 2025, the negative impact of the Stelara sales decline, due to biosimilar competition, on worldwide operational sales was approximately 5.9%.
Current filing · verify on EDGAR →
In the fiscal six months of 2026, the negative impact of the STELARA sales decline, due to biosimilar competition, on worldwide operational sales was approximately 5.0%.
Prior filing · verify on EDGAR →
Innovative Medicine segment sales in the fiscal six months of 2025 were $29.1 billion, an increase of 3.6% as compared to the same period a year ago, with an operational increase of 4.0% and a negative currency impact of 0.4%.
Current filing · verify on EDGAR →
Innovative Medicine segment sales in the fiscal six months of 2026 were $31.8 billion, an increase of 9.4% as compared to the same period a year ago, with an operational increase of 7.1% and a positive currency impact of 2.3%.
Prior filing · view on EDGAR →
TREMFYA 2,142 1,714 25.0 25.4 (0.4)
Current filing · view on EDGAR →
TREMFYA 3,654 2,142 70.6 67.8 2.8
Prior filing · view on EDGAR →
CARVYKTI 808 343 * * * DARZALEX 6,776 5,570 21.7 22.0 (0.3)
Current filing · view on EDGAR →
DARZALEX 8,171 6,776 20.6 17.7 2.9
Prior filing · view on EDGAR →
CARVYKTI 808 343 * * *
Current filing · view on EDGAR →
CARVYKTI 1,254 808 55.1 52.1 3.0
Prior filing · verify on EDGAR →
The MedTech segment sales in the fiscal six months of 2025 were $16.6 billion, an increase of 5.0% as compared to the same period a year ago, with an operational increase of 5.1% and a negative currency impact of 0.1%.
Current filing · verify on EDGAR →
The MedTech segment sales in the fiscal six months of 2026 were $17.6 billion, an increase of 6.0% as compared to the same period a year ago, with an operational increase of 4.1% and a positive currency impact of 1.9%.
Prior filing · view on EDGAR →
Cardiovascular 2,313 1,873 23.5 22.3 1.2
Current filing · view on EDGAR →
Cardiovascular $2,404 $2,313 4.0 % 3.1 % 0.9 %
Prior filing · verify on EDGAR →
Consolidated earnings before provision for taxes on income for the fiscal six months of 2025 was $20.1 billion representing 44.1% of sales as compared to $9.5 billion in the fiscal six months of 2024, representing 21.6% of sales.
Current filing · verify on EDGAR →
Consolidated earnings before provision for taxes on income for the fiscal six months of 2026 was $12.7 billion representing 25.8% of sales as compared to $20.1 billion in the fiscal six months of 2025, representing 44.1% of sales.
Prior filing · verify on EDGAR →
The worldwide effective income tax rate for the fiscal six months was 17.8% in 2025 and 16.1% in 2024.
Current filing · verify on EDGAR →
The worldwide effective income tax rate for the fiscal six months was 15.5% in 2026 and 17.8% in 2025.
Prior filing · verify on EDGAR →
8.1 net cash generated from operating activities
Current filing · verify on EDGAR →
11.1 net cash generated from operating activities
Prior filing · view on EDGAR →
(2.1) repurchase of common stock
Current filing · view on EDGAR →
(4.2) repurchase of common stock
Prior filing · verify on EDGAR →
On April 15, 2025, the Board of Directors declared a regular cash dividend of $1.30 per share, payable on June 10, 2025, to shareholders of record as of May 27, 2025.
Current filing · verify on EDGAR →
On April 14, 2026, the Board of Directors declared a regular cash dividend of $1.34 per share, payable on June 9, 2026, to shareholders of record as of May 26, 2026.
Prior filing · verify on EDGAR →
As of June 29, 2025, the Company had cash, cash equivalents and marketable securities of approximately $18.9 billion and had approximately $50.8 billion of notes payable and long-term debt for a net debt position of $31.9 billion as compared to the prior year fiscal second quarter net debt position of $16.0 billion.
Current filing · verify on EDGAR →
As of June 28, 2026, the Company had cash, cash equivalents and marketable securities of approximately $20.8 billion and had approximately $49.0 billion of notes payable and long-term debt for a net debt position of $28.2 billion as compared to the prior year fiscal second quarter net debt position of $31.9 billion.
Prior filing · verify on EDGAR →
The Company anticipates that operating cash flows, the ability to raise funds from external sources, borrowing capacity from existing committed credit facilities and access to the commercial paper markets will continue to provide sufficient resources to fund operating needs, including the Company’s remaining balance of approximately $4.0 billion related to talc matters
Current filing · verify on EDGAR →
The Company anticipates that operating cash flows, the ability to raise funds from external sources, borrowing capacity from existing committed credit facilities and access to the commercial paper markets will continue to provide sufficient resources to fund operating needs, including the Company’s remaining balance of approximately $3.7 billion related to talc matters
Prior filing · verify on EDGAR →
the remaining approximately $1.1 billion to settle opioid litigation
Current filing · verify on EDGAR →
the remaining approximately $0.9 billion related to opioid settlements.
Key Changes
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high
Revenue grew 6.6% YoY to $25.3B
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high
SIMPONI biosimilars launched in Europe Q2 2026 with U.S. entry expected later in 2026; OPSUMIT generics entered U.S. late Q2 2026; company warns of future sales reductions for both franchises.
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high
New supply chain restructuring program initiated in Innovative Medicine with -750M estimated costs through 2029; recorded in Q2 2026, primarily asset impairments.
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high
Talc plaintiff count rose 8.5% to ~76,000; reserve reduced; NJ MDL Special Master excluded some plaintiff experts, company filed Motion to Show Cause seeking dismissal after plaintiffs withdrew two specific-causation experts.
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high
Multiple new IP challenges: CARVYKTI faces EU patent suit by 2seventy bio (hearing March 2027); SIMPONI biosimilar litigation against Accord (preliminary injunction hearing Sept 2026) and Alvotech; SPRAVATO trial vs. Sandoz completed, decision pending.
Summary
Johnson & Johnson delivered solid Q2 FY26 results with total revenue up 6.6% to $25.3B, driven by oncology portfolio strength. However, biosimilar and generic headwinds are intensifying: STELARA erosion now drags worldwide operational sales by 5.0% (7.0% in U.S.), SIMPONI biosimilars launched in Europe Q2 2026 with U.S. entry expected later this year, and OPSUMIT generics entered the U.S. late Q2.
The company explicitly warned both will reduce future sales. The company initiated a new Innovative Medicine supply chain restructuring program targeting $650-750M in costs through 2029, with $200M recorded in Q2 2026.
Talc litigation progressed with plaintiff count rising 8.5% to ~76,000 despite the reserve declining to $3.7B. the NJ MDL saw procedural wins as plaintiffs withdrew two specific-causation experts and the court granted J&J's Motion to Show Cause. IP litigation expanded significantly: CARVYKTI faces a new EU patent suit by 2seventy bio (with U.S. government intervention) scheduled for March 2027 hearing. SIMPONI biosimilar litigation against Accord includes a preliminary injunction motion hearing in September 2026. and SPRAVATO trial against Sandoz completed with decision pending. The Anti-Terrorism Act case returned to district court after the D.C. Circuit reaffirmed reversal of dismissal, and a $0.8B Auris acquisition judgment was paid in January 2026. Watch next quarter for SIMPONI U.S. biosimilar entry timing, STELARA U.S. erosion trajectory, and outcomes in the SPRAVATO trial decision and SIMPONI preliminary injunction hearing. The oncology portfolio's momentum must offset accelerating biosimilar/generic headwinds to sustain growth.
Section-by-Section Diff
Controls
Controls remain effective; Q2 2026 repurchased 970,250 shares for compensation programs vs. zero in Q2 2025.
Show 1 minor / wording change
Previous filing · verify on EDGAR →
During the fiscal second quarter of 2025, the Company did not repurchase any shares of Johnson & Johnson Common Stock in open-market transactions.
Current filing · verify on EDGAR →
During the fiscal second quarter of 2026, the Company repurchased an aggregate of 970,250 shares of Johnson & Johnson Common Stock in open-market transactions, all of which were purchased as part of a systematic plan to meet the needs of the Company’s compensation programs.
In Q2 2026, the Company repurchased 970,250 shares at an average price of $229.54 to meet compensation-program needs (stock-for-stock option exercises and systematic plan purchases). In Q2 2025, no shares were repurchased. This is a routine operational change reflecting compensation-plan activity, not a publicly-announced buyback program.
Legal Proceedings
Talc reserve reduced to $3.7B; new IP lawsuits for ERLEADA, SIMPONI, CARVYKTI; Auris judgment paid; securities/antitrust cases progressing.
Previous filing · verify on EDGAR →
Body powders containing talc, primarily JOHNSON’S Baby Powder 70,030
Current filing · verify on EDGAR →
As of June 28, 2026, there are approximately 76,000 plaintiffs in the United States with direct claims against the Company and its affiliates in pending lawsuits regarding injuries allegedly due to the use of body powders containing talc, primarily JOHNSON’S Baby Powder.
Talc plaintiff count increased from approximately 70,030 as of June 29, 2025 to approximately 76,000 as of June 28, 2026 — an increase of roughly 6,000 plaintiffs (8.5%) over the year. The Company continues to face new filings despite the bankruptcy dismissals and return to the tort system.
Previous filing · verify on EDGAR →
As of the second quarter 2025, the total present value of the reserve is approximately $4.0 billion, comprising previously executed settlement agreements, litigation defense and other costs. Approximately one-third of the reserve is recorded as a current liability.
Current filing · verify on EDGAR →
As of the second quarter of 2026, the total present value of the reserve for talc related matters is approximately $3.7 billion, comprising executed settlement agreements, litigation defense and other costs. Approximately 40% of the reserve is recorded as a current liability.
Talc reserve decreased from $4.0 billion (Q2 2025) to $3.7 billion (Q2 2026), a reduction of $300 million. The current-liability portion increased from one-third to 40%, indicating a higher proportion of near-term settlement and defense costs. The reserve now covers executed settlements and litigation defense, with no bankruptcy-plan component.
Previous filing · verify on EDGAR →
After the Texas dismissal, the Company announced it would not appeal the decision and returned to the tort system to litigate the talc claims and defend the safety of its products. Courts have begun to hold scheduling conferences and the Company is preparing to start bellwether trials in consolidated proceedings in the California JCCP in November 2025 and in the New Jersey MCL in January 2026.
Current filing · verify on EDGAR →
In the ovarian cancer multi-district litigation (MDL) in the United States District Court for the District of New Jersey, the court is addressing the Company's Daubert motions related to general causation, specific causation, and certain asbestos testing methods. In January 2026, the Special Master issued her Report and Recommendation related to general causation, excluding certain opinions by plaintiff experts, but also allowing other opinions to proceed. The Company has filed an appeal of the Report and Recommendation to the district court. In May 2026, the Special Master held evidentiary hearings on the Company's specific causation motion. Thereafter, the plaintiffs withdrew two of their specific causation experts. In June 2026, the Company filed a Motion to Show Cause requiring the plaintiffs to explain why the MDL should not be dismissed after they withdrew those experts. In July 2026, the court granted the Motion to Show Cause and a case management conference related to the motion is scheduled for August 2026. In July 2026, the Special Master issued her Report and Recommendation related to certain asbestos testing methods, granting in part the Company's motion.
The ovarian-cancer MDL in New Jersey has progressed through multiple Daubert hearings. The Special Master excluded some plaintiff expert opinions on general causation but allowed others; plaintiffs then withdrew two specific-causation experts, prompting the Company to file a Motion to Show Cause seeking dismissal of the MDL. The court granted the motion and scheduled a case-management conference for August 2026. This represents a procedural win for the Company, though the MDL has not yet been dismissed.
Previous filing · verify on EDGAR →
In December 2023, the Court granted Plaintiff’s motion for class certification. In January 2024, Defendants filed a petition with the Third Circuit under Federal Rule of Civil Procedure 23(f) for permission to appeal the Court’s order granting class certification, and in February 2024, the Third Circuit granted Defendants' petition. In February 2024, fact discovery closed, the Court ordered the parties to mediate, and stayed the case pending mediation. In May 2024, the parties participated in an unsuccessful mediation. In June 2024, at the parties' request, the Court lifted the stay for certain limited discovery, but otherwise kept the stay in place pending a decision from the Third Circuit on the 23(f) petition. Briefing on the 23(f) petition was completed in September 2024, and in March 2025, the Third Circuit heard oral argument.
Current filing · verify on EDGAR →
In July 2025, the Third Circuit affirmed the court's order granting class certification. In September 2025, the Company petitioned the Third Circuit for rehearing or rehearing en banc, which was denied in October 2025. In February 2026, the Company filed a writ of certiorari with the United States Supreme Court regarding the Third Circuit’s decision, which the Supreme Court denied in April 2026. Expert discovery is proceeding.
The talc securities class action advanced through the appellate process: the Third Circuit affirmed class certification in July 2025, the Company's rehearing petition was denied in October 2025, and the Supreme Court denied certiorari in April 2026. The case has now returned to expert discovery, with class certification final. This removes a key procedural defense and allows the case to proceed toward trial.
Previous filing · verify on EDGAR →
Certain insurers have appealed the Settlement Order and sought a stay of the order pending appeal, which the Delaware Bankruptcy Court denied in January 2025. The insurers then sought a stay of the order in the District Court for the District of Delaware, which also was denied. The insurers then appealed the denial of their request for a stay of the order to the Third Circuit Court of Appeals. The briefing of the Settlement Order appeal in the Delaware District Court was completed in April 2025, and the appeal is pending a decision from the Court. The briefing in the Third Circuit appeal of the denial of the stay order is ongoing.
Current filing · verify on EDGAR →
Certain insurers have appealed the Settlement Order and sought a stay of the Settlement Order pending appeal, which the Delaware Bankruptcy Court denied in January 2025. In August 2025, the district court denied the insurers' appeal of the Settlement Order. The insurers have appealed that decision to the Third Circuit. Briefing in the Third Circuit appeal is complete and a ruling is pending.
The Imerys Settlement Order appeal progressed: the district court denied the insurers' appeal in August 2025, and the insurers then appealed to the Third Circuit. Briefing in the Third Circuit is now complete and a ruling is pending. The settlement remains in effect while the appeal proceeds, but an adverse ruling could reopen disputes over indemnity and insurance proceeds.
Added in current filing · verify on EDGAR →
In October 2020, Fortis Advisors LLC, as representative of the former stockholders of Auris Health Inc. (Auris), filed a complaint against the Company alleging breach of contract, fraud, and other causes of action in connection with Ethicon’s acquisition of Auris in 2019. In January 2026, the Company paid a $0.8 billion judgment, inclusive of interest.
The Company paid a $0.8 billion judgment (including interest) in January 2026 to resolve the Auris Health acquisition dispute. The baseline filing did not disclose this matter in the legal-proceedings note, suggesting the judgment was entered and paid during the current fiscal year. This is a material cash outflow related to a 2019 acquisition dispute.
Added in current filing · verify on EDGAR →
In October 2019, Innovative Health, LLC filed a complaint against Biosense Webster, Inc. (BWI) in the United States District Court for the Central District of California. The complaint alleges that certain of BWI's business practices and contractual terms violate the antitrust laws of the United States and the State of California by restricting competition in the sale of High Density Mapping Catheters and Ultrasound Catheters. In May 2025, a jury returned its verdict in favor of Innovative Health. In August 2025, the court issued a permanent injunction concerning BWI's business practices. BWI appealed both the jury verdict and the permanent injunction. In June 2026, briefing of the appeal was completed.
The Biosense Webster antitrust case progressed to an adverse jury verdict in May 2025 and a permanent injunction in August 2025. BWI has appealed both, and briefing was completed in June 2026. The baseline filing did not disclose this matter in the legal-proceedings note, suggesting the verdict and injunction were entered during the current fiscal year. The permanent injunction may restrict BWI's business practices pending appeal.
Previous filing · verify on EDGAR → · paraphrased
In October 2018, two separate putative class actions were filed against Actelion Pharmaceuticals Ltd., Actelion Pharmaceuticals US, Inc. and Actelion Clinical Research, Inc. (collectively, Actelion) in the United States District Court for the District of Maryland and the United States District Court for the District of Columbia. The complaints allege that Actelion violated state and federal antitrust and unfair competition laws by allegedly refusing to supply generic pharmaceutical manufacturers with samples of TRACLEER. TRACLEER is subject to a Risk Evaluation and Mitigation Strategy required by the U.S. Food and Drug Administration, which imposes restrictions on distribution of the product. In January 2019, the plaintiffs dismissed the District of Columbia case and filed a consolidated complaint in the United States District Court for the District of Maryland. In September 2024, the district court granted plaintiffs' motion for class certification.
Current filing · verify on EDGAR →
In October 2018, two separate putative class actions were filed against Actelion Pharmaceuticals Ltd., Actelion Pharmaceuticals US, Inc. and Actelion Clinical Research, Inc. (collectively, Actelion) in the United States District Court for the District of Maryland and the United States District Court for the District of Columbia. The complaints allege that Actelion violated state and federal antitrust and unfair competition laws by allegedly refusing to supply generic pharmaceutical manufacturers with samples of TRACLEER. TRACLEER is subject to a Risk Evaluation and Mitigation Strategy required by the U.S. Food and Drug Administration, which imposes restrictions on distribution of the product. In January 2019, the plaintiffs dismissed the District of Columbia case and filed a consolidated complaint in the United States District Court for the District of Maryland. In September 2024, the district court granted plaintiffs' motion for class certification. In February 2026, the parties agreed to settle the matter. In July 2026, the court granted final approval of the settlement.
The TRACLEER antitrust class action was settled in February 2026 and received final court approval in July 2026. The baseline reported class certification in September 2024 but no settlement. The settlement resolves claims that Actelion violated antitrust laws by restricting generic manufacturers' access to TRACLEER samples under the REMS program.
Previous filing · verify on EDGAR → · paraphrased
In December 2023, a putative class action lawsuit was filed against the Company and Janssen Biotech Inc. (collectively, Janssen) in the United States District Court for the Eastern District of Virginia. The complaint alleges that Janssen violated federal and state antitrust laws and other state laws by delaying biosimilar competition with STELARA through Janssen's enforcement of patent rights covering STELARA. The complaint seeks damages and other relief. In August 2024, the court granted in part and denied in part Janssen's motion to dismiss plaintiffs' amended complaint.
Current filing · verify on EDGAR →
In December 2023, a putative class action lawsuit was filed against the Company and Janssen Biotech Inc. (collectively, Janssen) in the United States District Court for the Eastern District of Virginia. The complaint alleges that Janssen violated federal and state antitrust laws and other state laws by delaying biosimilar competition with STELARA through Janssen's enforcement of patent rights covering STELARA. The complaint seeks damages and other relief. In August 2024, the court granted in part and denied in part Janssen's motion to dismiss plaintiffs' amended complaint. In December 2025, the court granted plaintiffs' motion for class certification. In January 2026, the court granted summary judgment for Janssen on plaintiffs' claim regarding patents obtained through the acquisition of Momenta Pharmaceuticals, Inc. in 2020. In March 2026, plaintiffs appealed to the United States Court of Appeals for the Fourth Circuit.
The STELARA antitrust case progressed: the court granted class certification in December 2025, then granted summary judgment for Janssen in January 2026 on claims related to Momenta-acquired patents. Plaintiffs appealed the summary judgment in March 2026. The partial win narrows the case but leaves other antitrust claims alive.
Added in current filing · verify on EDGAR →
In December 2018, Janssen Biotech, Inc., Janssen Oncology, Inc., Janssen Research & Development, LLC, and the Company (collectively, Janssen) were served with a qui tam complaint on behalf of the United States, certain states, and the District of Columbia. The complaint alleges that Janssen violated the federal False Claims Act and state law when providing pricing information for ZYTIGA to the government in connection with direct sales and reimbursement programs. At this time, the federal and state governments have declined to intervene. In December 2021, the United States District Court for the District of New Jersey denied Janssen's motion to dismiss. Daubert proceedings are ongoing.
The ZYTIGA False Claims Act qui tam case, filed in December 2018 and served on the Company in that month, is now in Daubert proceedings (expert-admissibility hearings). The baseline filing did not disclose this matter in the legal-proceedings note, suggesting it was previously immaterial or the Daubert phase began during the current fiscal year. The case alleges Janssen provided false pricing information to government reimbursement programs.
Added in current filing · verify on EDGAR →
In August 2025, Xoma Corporation (Xoma) filed a complaint against Janssen Biotech, Inc. (Janssen) in the United States District Court for the Eastern District of Pennsylvania. The complaint alleges breach of contract, unjust enrichment, and declaratory relief claims against Janssen regarding the alleged failure to obtain a license from Xoma in connection with Janssen's commercialization of TREMFYA. In December 2025, the court denied Janssen's motion to dismiss.
Xoma Corporation filed a breach-of-contract suit in August 2025 alleging Janssen failed to obtain a required license for TREMFYA commercialization. The court denied Janssen's motion to dismiss in December 2025, allowing the case to proceed. This is a new commercial dispute that could result in royalty or damages claims.
Added in current filing · verify on EDGAR →
In June 2026, three Relators filed an Amended False Claims Act Complaint in the United States District Court for the Southern District of Florida alleging the Company and DePuy Synthes, along with Tenet Healthcare Corporation, Delray Medical Center, and West Boca Medical Center caused the submission of false claims to federal and Florida healthcare programs. The Relators are sales representatives for competitor companies, and the complaint was served following a decision by the Department of Justice to decline intervening in the case. The Company and DePuy Synthes disagree with and are defending themselves against these claims.
A new False Claims Act qui tam complaint was filed in June 2026 by competitor sales representatives alleging DePuy Synthes caused false claims to be submitted to federal and Florida healthcare programs. The DOJ declined to intervene, and the relators are prosecuting the case. This is a new government-proceedings matter that could result in treble damages if the relators prevail.
Previous filing · verify on EDGAR → · paraphrased
In July 2016, the Company and Janssen Products, LP were served with a qui tam complaint pursuant to the False Claims Act filed in the United States District Court for the District of New Jersey alleging the off-label promotion of two HIV products, PREZISTA and INTELENCE, and anti-kickback violations in connection with the promotion of these products. The complaint was filed under seal in December 2012. The federal and state governments have declined to intervene, and the lawsuit is being prosecuted by the relators. The court denied summary judgment on all claims in December 2021. Daubert motions were granted in part and denied in part in January 2022, and trial commenced in May 2024. In June 2024, a jury found no liability regarding the anti-kickback violations but found liability for a portion of the off-label promotion claims. The Company challenged the verdict on the off-label claims in post-trial briefing. In March 2025, the court dismissed the state law portion of the claims but entered judgment on the federal claims. The Company appealed the remainder of the verdict to the Third Circuit. The federal government has intervened for the limited purpose of defending the qui tam provision of the False Claims Act.
Current filing · verify on EDGAR →
In July 2016, the Company and Janssen Products, LP were served with a qui tam complaint pursuant to the False Claims Act filed in the United States District Court for the District of New Jersey alleging the off-label promotion of two HIV products, PREZISTA and INTELENCE, and anti-kickback violations in connection with the promotion of these products. The complaint was filed under seal in December 2012. The federal and state governments have declined to intervene, and the lawsuit is being prosecuted by the relators. The court denied summary judgment on all claims in December 2021. Daubert motions were granted in part and denied in part in January 2022, and trial commenced in May 2024. In June 2024, a jury found no liability regarding the anti-kickback violations but found liability for a portion of the off-label promotion claims. The Company challenged the verdict on the off-label claims in post-trial briefing. In March 2025, the court dismissed the state law portion of the claims but entered judgment on the federal claims. The Company appealed the remainder of the verdict to the Third Circuit. The federal government has intervened for the limited purpose of defending the qui tam provision of the False Claims Act. Briefing is complete and oral argument was held in March 2026. A decision is pending. In April 2026, the Third Circuit ordered the parties to engage in mediation.
The PREZISTA/INTELENCE False Claims Act appeal progressed: briefing was completed, oral argument was held in March 2026, and the Third Circuit ordered mediation in April 2026. The baseline reported the appeal was filed and the government intervened to defend the qui tam statute, but no oral argument or mediation order. The mediation order suggests the court may be encouraging settlement.
Previous filing · verify on EDGAR → · paraphrased
In March 2017, Janssen Biotech, Inc. (JBI) received a Civil Investigative Demand from the United States Department of Justice (DOJ) regarding a False Claims Act investigation concerning management and advisory services provided to rheumatology and gastroenterology practices that purchased REMICADE or SIMPONI ARIA. In August 2019, the DOJ notified JBI that it was closing the investigation. Subsequently, the United States District Court for the District of Massachusetts unsealed a qui tam False Claims Act complaint, which was served on the Company. The DOJ had declined to intervene in the qui tam lawsuit in August 2019. The Company filed a motion to dismiss, which was granted in part and denied in part.
Current filing · verify on EDGAR →
In March 2017, Janssen Biotech, Inc. (JBI) received a Civil Investigative Demand from the United States Department of Justice (DOJ) regarding a False Claims Act investigation concerning management and advisory services provided to rheumatology and gastroenterology practices that purchased REMICADE or SIMPONI ARIA. In August 2019, the DOJ notified JBI that it was closing the investigation. Subsequently, the United States District Court for the District of Massachusetts unsealed a qui tam False Claims Act complaint, which was served on the Company. The DOJ had declined to intervene in the qui tam lawsuit in August 2019. The Company filed a motion to dismiss, which was granted in part and denied in part. The court heard argument on the parties’ summary judgment motions in May 2026, but has not yet issued a decision. The court has scheduled a trial date in November 2026.
The REMICADE/SIMPONI ARIA False Claims Act qui tam case progressed: the court heard summary-judgment arguments in May 2026 and scheduled trial for November 2026. The baseline reported the motion to dismiss was granted in part and denied in part, but no summary-judgment hearing or trial date. The case is advancing toward trial.
Previous filing · verify on EDGAR → · paraphrased
In October 2017, certain United States service members and their families brought a complaint against a number of pharmaceutical and medical devices companies, including the Company and certain of its subsidiaries in the United States District Court for the District of Columbia, alleging that the defendants violated the United States Anti-Terrorism Act. The complaint alleges that the defendants provided funding for terrorist organizations through their sales practices pursuant to pharmaceutical and medical device contracts with the Iraqi Ministry of Health. In July 2020, the district court dismissed the complaint. In January 2022, the United States Court of Appeals for the District of Columbia Circuit reversed the district court's decision. In June 2024, the Supreme Court vacated the D.C. Circuit's decision and remanded the case to the D.C. Circuit for reconsideration.
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In October 2017, certain United States service members and their families brought a complaint against a number of pharmaceutical and medical devices companies, including the Company and certain of its subsidiaries in the United States District Court for the District of Columbia, alleging that the defendants violated the United States Anti-Terrorism Act. The complaint alleges that the defendants provided funding for terrorist organizations through their sales practices pursuant to pharmaceutical and medical device contracts with the Iraqi Ministry of Health. In July 2020, the district court dismissed the complaint. In January 2022, the United States Court of Appeals for the District of Columbia Circuit reversed the district court’s decision. In June 2024, the Supreme Court vacated the D.C. Circuit's decision and remanded the case to the D.C. Circuit for reconsideration. In January 2026, the D.C. Circuit affirmed its reversal of the district court's dismissal of the complaint. In April 2026, the D.C. Circuit denied the defendants' rehearing petition.
The Anti-Terrorism Act case progressed on remand: the D.C. Circuit affirmed its reversal of the dismissal in January 2026 and denied the defendants' rehearing petition in April 2026. The baseline reported the Supreme Court remanded the case in June 2024 for reconsideration. The D.C. Circuit's reaffirmation means the case will return to the district court for further proceedings, and the Company faces potential liability under the Anti-Terrorism Act.
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In May 2026, Janssen and Pharmascience Inc., Mallinckrodt PLC (now Keenova Therapeutics plc), and SpecGx LLC entered into a confidential settlement agreement. In June 2026, Janssen entered into a stipulated dismissal with Aurobindo Pharma USA, Inc. and a confidential settlement with Eugia Pharma Specialities Ltd. and Eugia US, LLC.
Janssen settled or dismissed INVEGA SUSTENNA patent-infringement cases with five generic manufacturers in May and June 2026: Pharmascience, Mallinckrodt (now Keenova), SpecGx, Aurobindo, and Eugia. The baseline reported these cases were pending. The settlements likely allow generic entry on agreed timelines, reducing future INVEGA SUSTENNA exclusivity.
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Beginning in February 2018, Janssen Inc. and Janssen Pharmaceutica NV initiated a Statement of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against generic manufacturers who have filed ANDSs seeking approval to market generic versions of INVEGA SUSTENNA before expiration of the listed patent. The following entities are named defendants: Pharmascience Inc. and Apotex Inc. The following Canadian patent is included in one or more cases: 2,655,335. In June 2024, the Supreme Court dismissed the Apotex case. In September 2024, the Supreme Court granted Pharmascience's motion to appeal the Federal Court's decision that the 2,655,335 Patent is not invalid.
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Beginning in February 2018, Janssen Inc. and Janssen Pharmaceutica NV initiated a Statement of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against generic manufacturers who have filed ANDSs seeking approval to market generic versions of INVEGA SUSTENNA before expiration of the listed patent. Pharmascience Inc. is a named defendant. The following Canadian patent is included in one or more cases: 2,655,335. In September 2024, the Supreme Court of Canada granted Pharmascience's motion to appeal the Federal Court's decision that the 2,655,335 Patent is not invalid. In July 2026, the Supreme Court of Canada dismissed Pharmascience's appeal.
The Supreme Court of Canada dismissed Pharmascience's appeal in July 2026, upholding the Federal Court's finding that Canadian Patent 2,655,335 covering INVEGA SUSTENNA is not invalid. This is a win for Janssen, preserving patent protection in Canada. The baseline reported the Supreme Court granted Pharmascience's appeal motion in September 2024; the current filing reports the appeal was dismissed.
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In January 2025, Aragon Pharmaceuticals, Inc., Janssen Inc., (collectively, Janssen Inc.) and Sloan-Kettering Institute for Cancer Research (SKI) initiated Statements of Claims under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against Sandoz Canada Inc. (Sandoz) in response to Sandoz’s filing of an ANDS seeking approval to market a generic version of ERLEADA before the expiration of CA Patent Nos. 3,008,345 (the ’345 patent), 2,875,767 (the ’767 patent), 2,885,415 (the ’415 patent), and 3,128,331 (the ’331 patent). Janssen Inc. and SKI are seeking an order enjoining Sandoz from marketing a generic version of ERLEADA before the expiration of the relevant patents.
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Beginning in January 2025, Aragon Pharmaceuticals, Inc., Janssen Inc. (collectively, Janssen Inc.), and Sloan-Kettering Institute for Cancer Research (SKI) initiated Statements of Claims under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against Sandoz Canada Inc. (Sandoz) in response to Sandoz’s filing of ANDSs seeking approval to market 60 mg and 240 mg generic versions of ERLEADA before the expiration of CA Patent Nos. 3,008,345; 2,875,767; 2,885,415; and 3,128,331. Janssen Inc. and SKI are seeking orders enjoining Sandoz from marketing 60 mg and 240 mg generic versions of ERLEADA before the expiration of the relevant patents. Trial is scheduled to begin in August 2026.
The ERLEADA Canadian patent case against Sandoz now has a trial date scheduled for August 2026. The baseline reported the case was initiated in January 2025 but no trial date. The current filing also clarifies that Sandoz filed ANDSs for both 60 mg and 240 mg strengths.
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Beginning in April 2025, Aragon Pharmaceuticals, Inc., Janssen Biotech, Inc., The Regents of the University of California, and Sloan-Kettering Institute for Cancer Research variously initiated patent infringement lawsuits in U.S. District Court for the District of New Jersey against generic manufactures who have filed ANDAs seeking approval to market generic versions of ERLEADA before the expiration of certain Orange Book listed Patents. The following entities are named defendants: Lupin Limited; Lupin Pharmaceuticals, Inc.; Hetero Labs Limited Unit V; and Hetero USA, Inc. The following U.S. patents are included in one or more cases: 8,445,507; 8,802,689; 9,338,159; 9,987,261; 9,481,663; 9,884,054; RE 49,353; 10,849,888; 10,702,508; and 11,963,952.
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Beginning in June 2025, Aragon Pharmaceuticals, Inc., Janssen Biotech, Inc., The Regents of the University of California, and Sloan-Kettering Institute for Cancer Research initiated a patent infringement lawsuit in the United States District Court for the District of New Jersey against Hetero Labs Limited Unit V and Hetero USA, Inc. who filed an ANDA seeking approval to market a 240 mg generic version of ERLEADA before the expiration of certain Orange Book Listed Patents. The following U.S. patents are included in the case: 8,445,507; 8,802,689; 9,338,159; 9,987,261; 9,481,663; 9,884,054; RE 49,353; 10,849,888; 10,702,508; 11,963,952; 12,303,493; and 12,303,497. In May 2026, the parties entered into a confidential settlement agreement, and the case was dismissed.
The ERLEADA patent case against Hetero was settled in May 2026 and dismissed. The baseline reported the case was initiated in April 2025 (the current filing says June 2025, likely a typo or amended-complaint date). The settlement likely allows Hetero to launch a generic on an agreed timeline. The current filing also adds four new patents to the case (12,303,493 and 12,303,497 appear twice in the quote, suggesting they were asserted in the Hetero case before settlement).
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Beginning in June 2026, Aragon Pharmaceuticals, Inc., Janssen Biotech, Inc., and Sloan-Kettering Institute for Cancer Research initiated a patent infringement lawsuit in the United States District Court for the District of New Jersey against MSN Pharmaceuticals Inc., MSN Laboratories Private Limited, and Novadoz Pharmaceuticals, LLC who filed an ANDA seeking approval to market 60 mg and 240 mg generic versions of ERLEADA before the expiration of certain Orange Book Listed Patents. The following U.S. patents are included in the case: 9,481,663; 11,963,952; 12,303,493; and 12,303,497.
A new ERLEADA patent-infringement lawsuit was filed in June 2026 against MSN Pharmaceuticals, MSN Laboratories, and Novadoz Pharmaceuticals, asserting four Orange Book patents. This is a new generic challenge to ERLEADA's 60 mg and 240 mg strengths.
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Beginning in May 2023, Janssen Pharmaceuticals, Inc. and Janssen Pharmaceutica NV filed patent infringement lawsuits in United States district courts against generic manufacturers who have filed ANDAs seeking approval to market generic versions of SPRAVATO before expiration of certain Orange Book Listed Patents. The following entities are named defendants: Sandoz Inc.; Hikma Pharmaceuticals Inc. USA; Hikma Pharmaceuticals PLC; and Alkem Laboratories Ltd. The following U.S. patents are included in one or more cases: 10,869,844; 11,173,134; 11,311,500; and 11,446,260.
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Beginning in May 2023, Janssen Pharmaceuticals, Inc. and Janssen Pharmaceutica NV filed patent infringement lawsuits in United States district courts against generic manufacturers who have filed ANDAs seeking approval to market generic versions of SPRAVATO before expiration of certain Orange Book Listed Patents. The following entities are named defendants: Sandoz Inc. and Alkem Laboratories Ltd. The following U.S. patents are included in one or more cases: 10,869,844; 11,173,134; 11,311,500; and 11,446,260. A trial against Sandoz Inc. took place in February 2026. Post-trial briefing is complete, and the parties await a decision from the court.
The baseline reported the case was pending against Sandoz, Hikma, and Alkem; the current filing omits Hikma, suggesting that case was settled or dismissed. A ruling against Janssen could allow Sandoz to launch a generic SPRAVATO.
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Beginning in March 2024, Intra-Cellular Therapies, Inc. (Intra-Cellular) filed patent infringement lawsuits in the United States District Court for the District of New Jersey against generic manufactures who have filed ANDAs seeking approval to market generic versions of CAPLYTA before expiration of certain Orange Book Listed Patents. The following entities are named defendants: Aurobindo Pharma Ltd., Aurobindo Pharma USA, Inc., Alkem Laboratories Ltd., Dr. Reddy’s Laboratories Inc., Dr. Reddy’s Laboratories Ltd., Hetero USA, Inc., Hetero Labs Ltd. Unit-V, Hetero Labs Ltd., MSN Laboratories Private Ltd., Zydus Pharmaceuticals (USA) Inc., and Zydus Lifesciences Ltd. The following U.S. Patents are included in one or more cases: US RE 48,825; RE 48,839; 8,648,077; 9,168,258; 9,199,995; 9,616,061; 9,956,227; 10,117,867; 10,464,938; 10,960,009; 11,026,951; 11,753,419; 11,980,617; 12,070,459; 12,090,155; 12,122,792; and 12,128,043. In July 2025, Intra-Cellular, Hetero USA, Inc., Hetero Labs Ltd. Unit-V, and Hetero Labs Ltd. entered into a confidential settlement agreement.
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Beginning in March 2024, Intra-Cellular Therapies, Inc. (Intra-Cellular) filed patent infringement lawsuits in the United States District Court for the District of New Jersey against generic manufacturers who have filed ANDAs seeking approval to market generic versions of CAPLYTA before expiration of certain Orange Book Listed Patents. The following entities are named defendants: Aurobindo Pharma Ltd., Aurobindo Pharma USA, Inc., Zydus Pharmaceuticals (USA) Inc., and Zydus Lifesciences Ltd. The following U.S. patents are included in one or more cases: RE 48,825; RE 48,839; 8,648,077; 9,168,258; 9,199,995; 9,616,061; 9,956,227; 10,117,867; 10,464,938; 10,960,009; 11,026,951; 11,753,419; 11,980,617; 12,070,459; 12,090,155; 12,122,792; 12,128,043; 12,409,176; and 12,410,195. In June 2026, Intra-Cellular, Aurobindo Pharma Ltd., and Aurobindo Pharma USA, Inc. entered into a confidential settlement agreement and the case was dismissed. Trial is scheduled to begin in March 2027 against Zydus Pharmaceuticals (USA) Inc. and Zydus Lifesciences Ltd.
The CAPLYTA patent cases progressed: Intra-Cellular settled with Aurobindo in June 2026 and scheduled trial against Zydus for March 2027. Reddy's, MSN, and Zydus. The current filing omits Alkem, Dr. Reddy's, and MSN, suggesting those cases were settled or dismissed. The current filing also adds four new patents (12,409,176 and 12,410,195 appear in the current quote).
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In January 2026, 2seventy bio, Inc. filed suit in the Unified Patent Court, Local Division of Brussels, against the Company, Janssen Biotech, Inc., Janssen Pharmaceuticals Inc., Janssen-Cilag International NV, Janssen Pharmaceutica NV, Janssen-Cilag NV, Janssen Biologics B.V., Janssen-Cilag B.V., Janssen-Cilag GmbH, Janssen-Cilag, Janssen-Cilag SpA, Janssen-Cilag A/S, Janssen-Cilag Aktiebolag, Janssen-Cilag Farmaceutica Lda., Legend Biotech Corporation, Legend Biotech USA Inc., Legend Biotech Ireland Limited, and Legend Biotech Belgium BV alleging that the manufacture and sale of CARVYKTI infringes EU Patent No. 3 689 383. In the suit, the exclusive licensee, 2seventy bio, Inc., seeks damages and an injunction. In May 2026, The United States of America, including the Department of Health and Human Services, Office of Technology Transfer, as the patent owner, intervened in the action. An oral hearing is scheduled for March 2027.
2seventy bio filed a patent-infringement suit in the Unified Patent Court in January 2026 alleging CARVYKTI infringes EU Patent 3,689,383. The U.S. government (HHS Office of Technology Transfer, the patent owner) intervened in May 2026. An oral hearing is scheduled for March 2027. This is a new IP challenge to CARVYKTI in Europe, seeking damages and an injunction.
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In February 2026, BIOCAD filed an unfair competition action against Genmab and Johnson & Johnson LLC in the Arbitrazh Court of Moscow Region seeking: (1) a declaration of entitlement to use the inventions claimed in Genmab’s EA Patent No. 015584 in the manufacture/marketing of their drug “Daratumia” (INN daratumumab) starting from March 24, 2026, on the basis that patent EA 015584 expires March 23, 2026; (2) a declaration that Genmab’s and Johnson & Johnson LLC’s actions in obtaining PTE extending Genmab’s EA Patent No. 037929 and sending warning letters to BIOCAD asserting infringement risks after March 24, 2026 constitute unfair competition under Article 14.8 of Law on Protection of Competition (EA 037929 has PTE until March 23, 2031); and (3) an order restraining Genmab and Johnson & Johnson LLC from creating obstacles to BIOCAD’s introduction of “Daratumia” into civil circulation starting from March 24, 2026.
BIOCAD filed an unfair-competition action in Russia in February 2026 challenging Genmab's and J&J's enforcement of a patent-term extension for DARZALEX (daratumumab) and seeking a declaration that BIOCAD can launch its biosimilar "Daratumia" starting March 24, 2026. This is a new IP dispute in Russia that could affect DARZALEX exclusivity in that market.
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In March 2026, Janssen Biotech, Inc. and Janssen Sciences Ireland Unlimited Company (collectively, Janssen) filed a patent infringement lawsuit in the United States District Court for the District of Delaware against Accord BioPharma, Inc. (Accord) and Bio-Thera Solutions, Ltd. in response to Accord’s filing of an aBLA seeking approval to market biosimilar versions of SIMPONI and SIMPONI ARIA and providing notice of commercial marketing pursuant to 42 U.S.C. § 262(l) (8) (A) for those biosimilar products. The following U.S. patents are currently included in that case: 8,017,325; 8,586,356; 8,852,889; 8,956,830; 9,170,249; 9,217,168; 9,475,858; 9,487,810; 9,663,810; 9,890,410; 12,129,292; 12,139,735; and 12,180,271. The following U.S. patents were dismissed without prejudice: 11,014,982; 11,041,020; 12,122,824; and 12,291,566. Janssen is seeking an order enjoining defendants from marketing their biosimilar versions of SIMPONI and SIMPONI ARIA before the expiration of the asserted patents. In May 2026, Janssen filed a motion for preliminary injunction. The court scheduled a hearing on the motion for September 2026.
Janssen filed a patent-infringement lawsuit in March 2026 against Accord BioPharma and Bio-Thera Solutions in response to Accord's aBLA for SIMPONI and SIMPONI ARIA biosimilars. Janssen filed a preliminary-injunction motion in May 2026, with a hearing scheduled for September 2026. This is a new biosimilar challenge to SIMPONI, and the preliminary-injunction motion suggests Accord may be preparing to launch imminently.
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In March 2026, Accord BioPharma, Inc., Intas Pharmaceuticals Ltd., and Bio-Thera Solutions, Ltd. submitted four petitions requesting inter partes review (IPR) of U.S. patent nos. 11,014,982; 11,041,020; 12,122,824; and 12,291,566. Janssen Biotech, Inc., as the Patent Owner, has requested that the USPTO deny institution of the IPRs.
Accord BioPharma, Intas, and Bio-Thera filed four IPR petitions in March 2026 challenging SIMPONI patents. Janssen has requested the USPTO deny institution. These IPRs run parallel to the district-court litigation and could invalidate key SIMPONI patents if successful.
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In June 2026, Janssen Biotech, Inc. and Janssen Sciences Ireland Unlimited Company (collectively, Janssen) filed a patent infringement lawsuit in the United States District Court for the Eastern District of Virginia against Alvotech hf. and Alvotech USA Inc. (Alvotech USA) in response to Alvotech USA’s filing of aBLAs seeking approval to market biosimilar versions of SIMPONI and SIMPONI ARIA and providing notice of commercial marketing pursuant to 42 U.S.C. § 262(l) (8) (A) for those biosimilar products. The following U.S. patents are included in the case: 8,017,325; 8,852,889; 8,956,830; 9,170,249; 9,217,168; 9,475,858; 9,487,810; 9,663,810; 9,890,410; 10,421,986; 11,225,516; 12,139,735; 12,534,524; and 12,595,454. Janssen is seeking an order enjoining defendants from marketing their biosimilar versions of SIMPONI and SIMPONI ARIA before the expiration of the asserted patents.
Janssen filed a second SIMPONI biosimilar patent-infringement lawsuit in June 2026, this time against Alvotech in the Eastern District of Virginia. Alvotech filed aBLAs for SIMPONI and SIMPONI ARIA and provided commercial-marketing notice. This is another new biosimilar challenge to SIMPONI, indicating multiple competitors are preparing to launch.
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In March 2016, Abiomed, Inc. filed a declaratory judgment action against Maquet Cardiovascular LLC (Maquet) in the U.S. District Court for the District of Massachusetts seeking a declaration that certain Impella products do not infringe Maquet patents, including U.S. Patent Nos. 7,022,100 (’100 patent); 8,888,728; and 9,327,068. Maquet counterclaimed for infringement of those patents against Abiomed, Inc., Abiomed Europe GmbH, and Abiomed R&D, Inc. (collectively, Abiomed), and later added claims for infringement of U.S. Patent Nos. 9,545,468; 9,561,314; and 9,597,437. After claim construction, Maquet alleged infringement of only the ’100 patent. In September 2021, the court granted Abiomed’s motion for summary judgment of non-infringement of the ’100 patent, and in September 2023, the district court entered final judgment in favor of Abiomed on all patents-in-suit. Maquet appealed. In November 2017, Maquet Cardiovascular LLC filed suit against Abiomed, Inc., Abiomed R&D, Inc., and Abiomed Europe GmbH (collectively, Abiomed) in the U.S. District Court for the District of Massachusetts, alleging that certain Impella products infringe U.S. Patent No. 9,789,238 (’238 patent). Maquet subsequently added U.S. Patent No. 10,238,783 (’783 patent). After claim construction, the court entered a stipulated judgment of non-infringement of both patents. Maquet appealed. On March 21, 2025, ... the U.S. Court of Appeals for the Federal Circuit left undisturbed the judgment
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In March 2016, Abiomed, Inc. filed a declaratory judgment action against Maquet Cardiovascular LLC (Maquet) in the United States District Court for the District of Massachusetts seeking a declaration that certain Impella products do not infringe Maquet patents. Maquet counterclaimed for infringement against Abiomed, Inc., Abiomed Europe GmbH, and Abiomed R&D, Inc. The following U.S. patents are at issue: 8,888,728; 9,327,068; 9,545,468; 9,561,314; and 9,597,437. In February 2026, the U.S. Court of Appeals for the Federal Circuit remanded the case after considering the district court's claim constructions. Discovery will begin based on the altered constructions. In November 2017, Maquet Cardiovascular LLC filed suit against Abiomed, Inc., Abiomed R&D, Inc., and Abiomed Europe GmbH in the United States District Court for the District of Massachusetts alleging that certain Impella products infringe Maquet patents. U.S. Patent No. 10,238,783 remains in the suit, and trial was held in May 2026. The jury returned a verdict in Abiomed's favor. Post-trial briefing is ongoing.
The Abiomed-Maquet IP litigation progressed: the Federal Circuit remanded the 2016 declaratory-judgment case in February 2026 for discovery under altered claim constructions, and the 2017 case went to trial in May 2026 with a jury verdict in Abiomed's favor. The baseline reported Maquet's appeal of the 2016 case and the Federal Circuit's March 2025 affirmance of non-infringement in the 2017 case. The current filing shows the 2016 case is back in discovery and the 2017 case is in post-trial briefing after a defense verdict.
Show 8 minor / wording changes
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In January 2025, Imerys and Cyprus each filed a certification of voting results, indicating that their respective Chapter 11 plans had been accepted by each voting class of talc claimants. A joint confirmation hearing for the plans began in April 2025 but was continued, at the request of Imerys and Cyprus, after issues arose relating to treatment of foreign claims under their respective Chapter 11 plans.
The current filing no longer discusses the Imerys and Cyprus Chapter 11 plan confirmation process or the continuation of the joint confirmation hearing. The baseline reported that voting results were certified in January 2025 and a confirmation hearing began in April 2025 but was continued due to foreign-claims issues. The current filing's silence suggests the confirmation process has either concluded, been superseded by the settlement, or remains stayed pending the settlement-order appeal.
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Beginning in 2014 and continuing to the present, the Company and Janssen Pharmaceuticals, Inc. (JPI), along with other pharmaceutical companies, have been named in close to 3,500 lawsuits related to the marketing of opioids, including DURAGESIC, NUCYNTA and NUCYNTA ER. Similar lawsuits have also been filed by private plaintiffs and organizations, including but not limited to the following: individual plaintiffs on behalf of children born with Neonatal Abstinence Syndrome (NAS); hospitals; and health insurers/payors. To date, the Company and JPI have litigated two of the cases to judgment and have prevailed in both, either at trial or on appeal. In July 2021, the Company announced finalization of an agreement to settle the state and subdivision claims for up to $5.0 billion. Approximately 80% of the all-in settlement was paid by the end of fiscal second quarter 2025. A few government entities opted out of the settlement. In September 2024, the Company reached an agreement to resolve the hospital cases. The Company and JPI continue to defend the cases brought by the remaining government entity litigants as well as the cases brought by private litigants. In total, there are under 27 remaining opioid cases against the Company and JPI in various state courts, 290 remaining cases in the Ohio multi-district litigation (MDL), and 2 additional cases in other federal courts. In addition, the Province of British Columbia filed suit against the Company and its Canadian affiliate Janssen Inc., and many other industry members, in Canada. That action was certified as an opt in class action on behalf of other provincial/territorial and the federal governments in Canada in January 2025. The defendants, including the Company, filed appeals from the certification order in late February 2025. Additional proposed class actions have been filed in Canada against the Company and Janssen Inc., and many other industry members, by and on behalf of people who used opioids (for personal injuries), municipalities and First Nations bands. The proposed class action in Quebec on behalf of residents diagnosed with opioid use disorder was authorized to proceed against Janssen Inc. and other industry members in April 2024; and leave to appeal was denied in October 2024. Starting in November 2019, a series of shareholder derivative complaints were filed against the Company as the nominal defendant and certain current and former directors and officers as defendants in the Superior Court of New Jersey. The complaint alleges breaches of fiduciary duties related to the marketing of opioids, and that the Company has suffered damages as a result of those alleged breaches. As of September 2024, all the complaints had been dismissed, and all appeals exhausted.
The entire opioid litigation section — covering approximately 3,500 lawsuits, the $5.0 billion settlement, remaining case counts, Canadian class actions, and shareholder derivative suits — has been removed from the current filing. The baseline reported that 80% of the settlement had been paid by Q2 2025, hospital cases were resolved in September 2024, and under 27 U.S. cases plus 290 MDL cases remained. The current filing's omission suggests the Company views the opioid matter as substantially resolved or no longer material to disclose in the quarterly legal-proceedings note.
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The table below contains the most significant of these cases and provides the approximate number of plaintiffs in the United States with direct claims in pending lawsuits regarding injuries allegedly due to the relevant product or product category as of June 29, 2025 ... Product or product category Number of plaintiffs Body powders containing talc, primarily JOHNSON’S Baby Powder 70,030 DePuy ASR XL Acetabular System and DePuy ASR Hip Resurfacing System 40 PINNACLE Acetabular Cup System 860 Pelvic meshes 5,350 ETHICON PHYSIOMESH Flexible Composite Mesh 120 ELMIRON 920
The current filing no longer includes the tabular summary of plaintiff counts for ASR Hip, PINNACLE, pelvic meshes, PHYSIOMESH, and ELMIRON. The baseline table showed 40 ASR plaintiffs, 860 PINNACLE, 5,350 pelvic mesh, 120 PHYSIOMESH, and 920 ELMIRON as of June 29, 2025. The current filing retains narrative discussion of these product-liability matters but omits the quantitative snapshot, suggesting the Company views these counts as no longer material or stable enough to warrant quarterly tabular disclosure.
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In February 2024, a putative class action was filed against the Company and the Pension & Benefits Committee of Johnson & Johnson in the United States District Court for the District of New Jersey. The complaint alleges that defendants breached fiduciary duties under the Employee Retirement Income Security Act (ERISA) by allegedly mismanaging the Company's prescription-drug benefits program. The complaint seeks damages and other relief. In March 2025, plaintiffs filed a second amended complaint.
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In February 2024, a putative class action was filed against the Company and the Pension & Benefits Committee of Johnson & Johnson in the United States District Court for the District of New Jersey. The complaint alleges that defendants breached fiduciary duties under the Employee Retirement Income Security Act (ERISA) by allegedly mismanaging the Company’s prescription-drug benefits program. The complaint seeks damages and other relief. In March 2025, plaintiffs filed a second amended complaint. In November 2025, the court granted defendants' motion to dismiss plaintiffs' fiduciary duty claims. Plaintiffs voluntarily withdrew their remaining claim, and the court entered final judgment in defendants' favor in January 2026. Plaintiffs appealed to the United States Court of Appeals for the Third Circuit.
The ERISA prescription-drug benefits case was dismissed in November 2025, final judgment was entered in January 2026, and plaintiffs appealed to the Third Circuit. The baseline reported a second amended complaint was filed in March 2025 but no dismissal. The Company prevailed at the district-court level, but the appeal is pending.
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Beginning in September 2020, Janssen Pharmaceuticals, Inc., Janssen Pharmaceutica NV, and Janssen Research & Development, LLC filed patent infringement lawsuits in United States district courts against generic manufacturers who have filed ANDAs seeking approval to market generic versions of INVEGA TRINZA before expiration of the Orange Book Listed Patent. The following entities are named defendants: Mylan Laboratories Limited; Mylan Pharmaceuticals Inc.; and Mylan Institutional LLC. The following U.S. patent is included in one or more cases: 10,143,693. In May 2023, the District Court issued a decision finding that Mylan’s proposed generic product infringes the asserted patent and that the patent is not invalid. Mylan appealed the decision, and in March 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the district court's decision. In May 2025, Mylan filed a petition for panel rehearing or rehearing en banc with the U.S. Court of Appeals for the Federal Circuit. In July 2025, the court denied Mylan's petition.
The INVEGA TRINZA Mylan patent case, which concluded with the Federal Circuit denying Mylan's rehearing petition in July 2025, is no longer discussed in the current filing. The baseline reported the Federal Circuit affirmed the district court's infringement finding in March 2025 and denied rehearing in July 2025. The current filing's omission suggests the case is fully resolved in Janssen's favor and no longer requires disclosure.
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Beginning in April 2025, Aragon Pharmaceuticals, Inc., Janssen Biotech, Inc., The Regents of the University of California, and Sloan-Kettering Institute for Cancer Research variously initiated patent infringement lawsuits in U.S. District Court for the District of New Jersey against generic manufactures who have filed ANDAs seeking approval to market generic versions of ERLEADA before the expiration of certain Orange Book listed Patents. The following entities are named defendants: Lupin Limited; Lupin Pharmaceuticals, Inc.; Hetero Labs Limited Unit V; and Hetero USA, Inc.
The ERLEADA patent case against Lupin Limited and Lupin Pharmaceuticals, reported as initiated in April 2025 in the baseline, is no longer discussed in the current filing. The current filing retains the Hetero case (now settled) and adds a new MSN/Novadoz case, but omits Lupin. This suggests the Lupin case was settled, dismissed, or consolidated with another matter.
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Beginning in January 2024, Janssen Inc. and Mitsubishi Tanabe Pharma Corporation initiated Statements of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against generic manufacturers who filed ANDSs seeking approval to market generic versions of INVOKANA before expiration of the listed patents. The following entities are named defendants Jamp Pharma Corporation (Jamp) and Apotex Inc. (Apotex). The following Canadian patents are included in one or more cases 2,534,024 and 2,671,357. The Company entered into confidential settlement agreements with Jamp, in April 2025, and with Apotex, in July 2025.
The INVOKANA Canadian patent cases against Jamp and Apotex, which were settled in April and July 2025, are no longer discussed in the current filing. The baseline reported both settlements were executed. The current filing's omission suggests these cases are fully resolved and no longer require disclosure.
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Beginning in March 2021, Janssen Pharmaceuticals, Inc., Bayer Pharma AG, Bayer AG and Bayer Intellectual Property GmbH filed patent infringement lawsuits in United States district courts against generic manufacturers who have filed ANDAs seeking approval to market generic versions of XARELTO before expiration of certain Orange Book Listed Patents. The following entities are named defendants: Dr. Reddy’s Laboratories, Inc.; Dr. Reddy’s Laboratories, Ltd.; Lupin Limited; Lupin Pharmaceuticals, Inc.; Taro Pharmaceutical Industries Ltd.; Taro Pharmaceuticals U.S.A., Inc.; Teva Pharmaceuticals USA, Inc.; Mylan Pharmaceuticals Inc.; Mylan Inc.; Mankind Pharma Limited; Apotex Inc.; Apotex Corp.; Cipla Ltd.; Cipla USA Inc.; and InvaGen Pharmaceuticals, Inc. The following U.S. patents are included in one or more cases: 9,539,218 and 10,828,310. U.S. Patent No. 10,828,310 was also under consideration by the USPTO in an IPR proceeding. In July 2023, the USPTO issued a final written decision finding the claims of the patent invalid. In September 2023, Bayer Pharma AG filed an appeal to the U.S. Court of Appeals for the Federal Circuit. Oral argument was heard in May 2025.
The baseline reported the USPTO found Patent 10,828,310 invalid in July 2023 and Bayer appealed. The current filing's omission suggests the Federal Circuit ruled (likely affirming invalidity) and the XARELTO patent cases were resolved or settled.
MD&A
Revenue grew 6.6% YoY to $49.4B driven by oncology/immunology strength; STELARA biosimilar erosion accelerated; new restructuring programs initiated.
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For the fiscal six months of 2025, worldwide sales were $45.6 billion, a total increase of 4.1%, including an operational* increase of 4.4% as compared to 2024 fiscal six months sales of $43.8 billion.
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For the fiscal six months of 2026, worldwide sales were $49.4 billion, a total increase of 8.2%, including an operational* increase of 6.0% as compared to 2025 fiscal six months sales of $45.6 billion.
Six-month revenue accelerated from 4.1% total growth (4.4% operational) in FY2025 to 8.2% total growth (6.0% operational) in FY2026, reaching $49.4 billion. The operational growth rate improved by 160 basis points year-over-year, indicating stronger underlying business momentum despite continued STELARA biosimilar headwinds.
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In the fiscal six months of 2025, the negative impact of the Stelara sales decline, due to biosimilar competition, on worldwide operational sales was approximately 5.9%.
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In the fiscal six months of 2026, the negative impact of the STELARA sales decline, due to biosimilar competition, on worldwide operational sales was approximately 5.0%.
STELARA biosimilar erosion moderated slightly from a 5.9% drag on worldwide operational sales in FY2025 to 5.0% in FY2026. However, the U.S. impact worsened from 6.7% to 7.0%, while international improved from 5.0% to 2.5%, suggesting the U.S. biosimilar transition is intensifying while international markets stabilize.
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Innovative Medicine segment sales in the fiscal six months of 2025 were $29.1 billion, an increase of 3.6% as compared to the same period a year ago, with an operational increase of 4.0% and a negative currency impact of 0.4%.
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Innovative Medicine segment sales in the fiscal six months of 2026 were $31.8 billion, an increase of 9.4% as compared to the same period a year ago, with an operational increase of 7.1% and a positive currency impact of 2.3%.
Innovative Medicine segment accelerated sharply from 3.6% total growth (4.0% operational) in FY2025 to 9.4% total growth (7.1% operational) in FY2026, reaching $31.8 billion. The operational growth rate improved by 310 basis points, driven by oncology portfolio strength (DARZALEX, CARVYKTI, TECVAYLI, TALVEY) and TREMFYA momentum offsetting STELARA declines.
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TREMFYA 2,142 1,714 25.0 25.4 (0.4)
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TREMFYA 3,654 2,142 70.6 67.8 2.8
TREMFYA six-month sales surged 70.6% to $0.8 billion in FY2026 versus 25.0% growth to $2.1 billion in FY2025. The acceleration reflects share gains across all indications with significant IBD launch momentum, positioning TREMFYA as a key growth driver offsetting STELARA biosimilar losses in the immunology portfolio.
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CARVYKTI 808 343 * * * DARZALEX 6,776 5,570 21.7 22.0 (0.3)
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DARZALEX 8,171 6,776 20.6 17.7 2.9
DARZALEX six-month sales grew 20.6% to $0.8 billion in FY2026 versus 21.7% growth to $6.8 billion in FY2025. Growth remains robust at over 20% driven by strong share gains and market expansion in multiple myeloma, though the rate moderated slightly from the prior year as the base scales.
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CARVYKTI 808 343 * * *
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CARVYKTI 1,254 808 55.1 52.1 3.0
CARVYKTI six-month sales grew 55.1% to $0.8 billion in FY2026 versus growth from $343 million to $45.6 billion in FY2025 (135% growth). While the percentage rate decelerated as the base expanded, absolute dollar growth remained strong, driven by continued share gains, site expansion, and capacity scaling in CAR-T therapy for multiple myeloma.
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The decline was partially offset by growth of TREMFYA (guselkumab) due to share gains across all indications with significant IBD launch momentum and market growth as well as growth in Other Immunology driven by sales of IMAAVY (nipocalimab) and ICOTYDE (icotrokinra) in the U.S.
The company disclosed new U.S. sales of IMAAVY (nipocalimab) and ICOTYDE (icotrokinra) contributing to Other Immunology growth in Q2 FY2026. These are recent launches not mentioned in the prior-year filing, representing pipeline progression in immunology beyond the established TREMFYA/STELARA/SIMPONI portfolio.
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Biosimilars for SIMPONI have entered the European market in the second quarter of 2026, with a potential U.S. entrant later in 2026. This will likely result in a reduction in future sales.
The company disclosed that SIMPONI biosimilars launched in Europe in Q2 FY2026, with a potential U.S. launch later in 2026. This represents a new biosimilar erosion headwind for the immunology portfolio beyond STELARA and REMICADE, with the company explicitly warning of future sales reductions.
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The sales growth of OPSUMIT (macitentan)/OPSYNVI (macitentan/tadalafil) was driven by share gains and market growth partially offset by the U.S. inventory burn related to expected generic competition. Generic competition for OPSUMIT entered the U.S. market late in the second quarter of 2026, which will likely result in a reduction in future sales.
The company disclosed that generic competition for OPSUMIT entered the U.S. market late in Q2 FY2026, with inventory burn already impacting sales. This represents a new erosion headwind in the pulmonary hypertension portfolio, with the company explicitly warning of future sales reductions.
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The MedTech segment sales in the fiscal six months of 2025 were $16.6 billion, an increase of 5.0% as compared to the same period a year ago, with an operational increase of 5.1% and a negative currency impact of 0.1%.
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The MedTech segment sales in the fiscal six months of 2026 were $17.6 billion, an increase of 6.0% as compared to the same period a year ago, with an operational increase of 4.1% and a positive currency impact of 1.9%.
MedTech segment six-month sales grew 6.0% to $17.6 billion in FY2026 versus 5.0% growth to $16.6 billion in FY2025. However, operational growth decelerated from 5.1% to 4.1%, indicating underlying business momentum slowed despite favorable currency tailwinds. The deceleration reflects tougher comparisons after the Shockwave acquisition anniversary and China volume-based procurement headwinds.
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Cardiovascular 2,313 1,873 23.5 22.3 1.2
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Cardiovascular $2,404 $2,313 4.0 % 3.1 % 0.9 %
Cardiovascular franchise Q2 growth decelerated sharply from 23.5% total (22.3% operational) in FY2025 to 4.0% total (3.1% operational) in FY2026. The prior-year period included the Shockwave acquisition boost; the current period reflects tougher comparisons, with Abiomed declining 2.0% and Electrophysiology growth moderating to 4.4% from 11.0% due to competitive pressures in Pulsed Field Ablation catheters and China inventory dynamics.
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Cost of products sold increased as a percent to sales driven by: •Increased intangible asset amortization expense related to the Intra-Cellular acquisition in the Innovative Medicine business •Unfavorable product mix driven by the decline of STELARA sales in the Innovative Medicine business •Unfavorable transactional currency in the Innovative Medicine business •Macroeconomic factors in the MedTech business
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Cost of products sold decreased slightly as a percent to sales driven by: •Operational drivers and favorable currency in the Innovative Medicine and MedTech businesses partially offset by •Unfavorable product mix primarily driven by the decline of STELARA sales in the Innovative Medicine business •Impact of tariffs in the MedTech business
The company now explicitly cites "Impact of tariffs in the MedTech business" as a COGS headwind in FY2026, replacing the prior year's generic "Macroeconomic factors" language. This represents a more specific disclosure of tariff-related cost pressures affecting the MedTech segment, though the filing does not quantify the dollar impact.
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Consolidated earnings before provision for taxes on income for the fiscal six months of 2025 was $20.1 billion representing 44.1% of sales as compared to $9.5 billion in the fiscal six months of 2024, representing 21.6% of sales.
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Consolidated earnings before provision for taxes on income for the fiscal six months of 2026 was $12.7 billion representing 25.8% of sales as compared to $20.1 billion in the fiscal six months of 2025, representing 44.1% of sales.
Six-month pre-tax earnings declined from $20.1 billion (44.1% margin) in FY2025 to $12.7 billion (25.8% margin) in FY2026, a 1,830 basis point margin compression. However, FY2025 included a $7.0 billion talc reserve reversal; excluding that one-time benefit, the underlying comparison is more favorable. The current period includes $0.8 billion in talc charges and new restructuring costs.
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In the fiscal second quarter of 2026, the Company initiated a supply chain restructuring program primarily in the Innovative Medicine segment to exit certain manufacturing locations as part of its optimization efforts to streamline operations. The program is expected to be substantially complete by the end of 2029 with estimated costs between $650 million and $750 million, and include site and supplier exit costs, decommissioning and asset impairments costs. Restructuring expenses of $200 million, primarily related to asset impairments, were recorded in the fiscal second quarter of 2026.
The company initiated a new supply chain restructuring program in Q2 FY2026 to exit certain Innovative Medicine manufacturing locations, with estimated total costs of $650-750 million through 2029. This is a new multi-year program not present in the prior filing, with $200 million already recorded in Q2 FY2026, signaling ongoing operational optimization efforts.
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The worldwide effective income tax rate for the fiscal six months was 17.8% in 2025 and 16.1% in 2024.
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The worldwide effective income tax rate for the fiscal six months was 15.5% in 2026 and 17.8% in 2025.
The six-month effective tax rate declined from 17.8% in FY2025 to 15.5% in FY2026, a 230 basis point improvement. This represents a favorable tax development, though the filing does not detail the specific drivers of the rate reduction.
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8.1 net cash generated from operating activities
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11.1 net cash generated from operating activities
Six-month operating cash flow increased from $8.1 billion in FY2025 to $0.8 billion in FY2026, a $3.0 billion or 37% improvement. This reflects stronger earnings generation and improved working capital management, providing increased financial flexibility for capital allocation.
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(2.1) repurchase of common stock
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(4.2) repurchase of common stock
Six-month share repurchases doubled from $2.1 billion in FY2025 to $4.2B in FY2026, reflecting increased capital return to shareholders. This represents a significant acceleration in buyback activity, consistent with stronger cash generation and the company's capital allocation priorities.
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On April 15, 2025, the Board of Directors declared a regular cash dividend of $1.30 per share, payable on June 10, 2025, to shareholders of record as of May 27, 2025.
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On April 14, 2026, the Board of Directors declared a regular cash dividend of $1.34 per share, payable on June 9, 2026, to shareholders of record as of May 26, 2026.
The quarterly dividend increased from $1.30 per share in April 2025 to $1.34 per share in April 2026, a 3.1% increase. This represents the company's continued commitment to returning cash to shareholders through regular dividend growth.
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As of June 29, 2025, the Company had cash, cash equivalents and marketable securities of approximately $18.9 billion and had approximately $50.8 billion of notes payable and long-term debt for a net debt position of $31.9 billion as compared to the prior year fiscal second quarter net debt position of $16.0 billion.
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As of June 28, 2026, the Company had cash, cash equivalents and marketable securities of approximately $20.8 billion and had approximately $49.0 billion of notes payable and long-term debt for a net debt position of $28.2 billion as compared to the prior year fiscal second quarter net debt position of $31.9 billion.
Net debt improved from $31.9 billion at Q2 FY2025 to $28.2 billion at Q2 FY2026, a $3.7 billion reduction. This reflects debt paydown of $1.8 billion (from $50.8B to $49.0B) and cash balance growth of $1.9 billion (from $18.9B to $20.8B), demonstrating improved balance sheet strength and deleveraging progress.
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The Company anticipates that operating cash flows, the ability to raise funds from external sources, borrowing capacity from existing committed credit facilities and access to the commercial paper markets will continue to provide sufficient resources to fund operating needs, including the Company’s remaining balance of approximately $4.0 billion related to talc matters
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The Company anticipates that operating cash flows, the ability to raise funds from external sources, borrowing capacity from existing committed credit facilities and access to the commercial paper markets will continue to provide sufficient resources to fund operating needs, including the Company’s remaining balance of approximately $3.7 billion related to talc matters
The remaining talc liability balance declined from approximately $4.0 billion at Q2 FY2025 to approximately $3.7 billion at Q2 FY2026, a $0.3 billion reduction. This reflects partial settlement payments during the period, with the company continuing to work through the talc-related obligations.
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In July 2023, Janssen Pharmaceuticals, Inc. (Janssen) filed litigation against the U.S. Department of Health and Human Services as well as the Centers for Medicare and Medicaid Services challenging the constitutionality of the IRA's Medicare Drug Price Negotiation Program. The litigation requests a declaration that the IRA violates Janssen’s rights under the First Amendment and the Fifth Amendment to the Constitution and therefore that Janssen is not subject to the IRA’s mandatory pricing scheme. The impact of the IRA on our business and the broader pharmaceutical industry remains uncertain, as litigation filed by Janssen and other pharmaceutical companies remains ongoing and while CMS has publicly announced the maximum fair price for each of the selected drugs, implementation of the program is still in progress. In April 2024, Janssen appealed the district court’s denial of its summary judgment motion to the Third Circuit.
The detailed discussion of Janssen's constitutional challenge to the IRA's Medicare Drug Price Negotiation Program was removed from the FY2026 filing. The prior-year filing included a full paragraph on the litigation status, including the April 2024 Third Circuit appeal. The removal suggests the litigation is no longer viewed as material disclosure, possibly due to unfavorable court rulings or the company's decision to participate in the program.
Show 8 minor / wording changes
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The estimated costs of the total program are between $0.9 billion - $1.0 billion and is expected to be completed over the next two years.
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The estimated costs of the total program are between $0.6 billion - $0.7 billion and is expected to be substantially completed by the end of fiscal year 2026.
The Surgery franchise restructuring program cost estimate was reduced from $0.9-1.0 billion to $0.6-0.7 billion, and the completion timeline was accelerated from "over the next two years" (from mid-2025) to "by the end of fiscal year 2026." Total project costs of $0.3 billion have been recorded to date. This represents a favorable revision, with lower expected costs and faster completion.
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Total project costs of approximately $0.6 billion have been recorded since the restructuring was announced.
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This program will be completed as of the fiscal fourth quarter of 2026 at a total project cost of approximately $1.0 billion.
The Orthopaedics restructuring program (initiated in fiscal 2023) will be completed in Q4 FY2026 at a total cost of approximately $1.0 billion, up from $0.6 billion recorded through mid-2025. The company has now recorded $0.8 billion to date, indicating the program is nearing completion with final costs higher than initially disclosed.
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Furthermore, in June 2025, the Company secured a new 364-day Credit Facility of $10 billion (expiration on June 24, 2026) which may be used for general corporate purposes including to support our commercial paper borrowings.
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Furthermore, in June 2026, the Company secured a new 364-day Credit Facility of $12.5 billion (expiration on June 23, 2027) which may be used for general corporate purposes including to support commercial paper borrowings.
The company increased its 364-day revolving credit facility from $10 billion (June 2025) to $12.5 billion (June 2026), a 25% increase. This provides additional liquidity headroom and financial flexibility, though the filing does not explain the rationale for the upsize.
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the remaining approximately $1.1 billion to settle opioid litigation
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the remaining approximately $0.9 billion related to opioid settlements.
The remaining opioid settlement liability declined from approximately $1.1 billion at Q2 FY2025 to approximately $0.9 billion at Q2 FY2026, a $0.2 billion reduction. This reflects partial settlement payments during the period, with the company continuing to work through the opioid-related obligations.
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The Inflation Reduction Act (IRA) contains provisions that redesign the Medicare Part D benefit in various ways, including by shifting a greater portion of costs to manufacturers within certain coverage phases and replacing the Part D coverage gap discount program with a new manufacturer discounting program.
The standalone paragraph describing the IRA's Medicare Part D redesign provisions was removed from the FY2026 filing. The prior-year filing included a detailed explanation of the IRA's impact on manufacturer cost-sharing. The current filing still references "Medicare Part D redesign" impacts on individual product sales but no longer provides the policy-level overview.
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On December 15, 2022, the European Union (EU) Member States formally adopted the EU’s Pillar Two Directive, which generally provides for a minimum effective tax rate of 15%, as established by the Organization for Economic Co-operation and Development (OECD) Pillar Two Framework that was supported by over 130 countries worldwide. Several EU and non-EU countries have enacted Pillar Two legislation with an initial effective date of January 1, 2024, with other aspects of the law effective in 2025 or later. While countries continue to enact new provisions or issue new regulations this could have an impact to the Company’s effective tax rate. The Company will continue to monitor further developments to determine any potential impact in the countries in which we operate, such as the recently announced understanding between the U.S. and the G7 of a side-by-side system that would fully exclude U.S. parented groups from certain provisions of the Pillar Two Framework.
The detailed discussion of the OECD Pillar Two global minimum tax framework and its potential impact on the company's effective tax rate was removed from the FY2026 filing. The prior-year filing included a full paragraph on the EU Pillar Two Directive, country-by-country implementation, and the U.S.-G7 understanding. The removal suggests the company views the Pillar Two impact as less material or uncertain than in the prior year.
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Although the long-term implications of Russia’s invasion of Ukraine are difficult to predict at this time, the financial impact of the conflict in the fiscal second quarter of 2025, including accounts receivable or inventory reserves, was not material. As of the fiscal six months ending June 29, 2025, and the fiscal year ending December 29, 2024, the business of the Company’s Russian subsidiaries represented less than 1% of the Company’s consolidated assets and represented approximately 1% of revenues. The Company does not maintain Ukrainian subsidiaries. In March of 2022, the Company took steps to suspend all advertising, enrollment in clinical trials, and any additional investment in Russia. The Company continues to supply products relied upon by patients for healthcare purposes.
The standalone Russia-Ukraine war section was removed from the FY2026 filing. The prior-year filing included two paragraphs detailing the immaterial financial impact, the <1% revenue/asset exposure, and the March 2022 operational suspension. The current filing consolidates regional conflicts into a single sentence: "The long-term implications of regional conflicts on the Company are difficult to predict. The financial impact of known existing conflicts in the fiscal second quarter of 2026 was not material." This represents a disclosure simplification, not a change in underlying exposure.
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Although the long-term implications of the conflict in the Middle East are difficult to predict at this time, the financial impact of the conflict in the fiscal second quarter of 2025, including accounts receivable or inventory reserves, was not material. As of the fiscal six months ending June 29, 2025, and the fiscal year ending December 29, 2024, the business of the Company’s Israel subsidiaries represented less than 1% of both Company’s consolidated assets and revenues.
The standalone Middle East conflict section was removed from the FY2026 filing. The prior-year filing included a paragraph detailing the immaterial financial impact and the <1% Israel revenue/asset exposure. The current filing consolidates regional conflicts into a single sentence: "The long-term implications of regional conflicts on the Company are difficult to predict. The financial impact of known existing conflicts in the fiscal second quarter of 2026 was not material." This represents a disclosure simplification, not a change in underlying exposure.
Notes
New supply chain restructuring program initiated in Innovative Medicine; expanded IP litigation across multiple products; updated contingent liabilities.
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In the fiscal second quarter of 2026, the Company initiated a supply chain restructuring program primarily in the Innovative Medicine segment to exit certain manufacturing locations as part of its optimization efforts to streamline operations. The program is expected to be substantially complete by the end of 2029 with estimated costs between $650 million and $750 million, and include site and supplier exit costs, decommissioning and asset impairments costs. Restructuring expenses of $200 million, primarily related to asset impairments, were recorded in the fiscal second quarter of 2026.
The Company initiated a new restructuring program in Q2 FY2026 targeting its Innovative Medicine supply chain, with expected costs of $650-750 million through 2029. The program recorded $200 million in charges in Q2 2026, primarily asset impairments. This is a new multi-year initiative not present in the prior period.
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Restructuring expenses of $29 million were recorded in the fiscal second quarter of 2025. The estimated costs of the total program are between $0.9 billion - $1.0 billion and is expected to be completed over the next two years.
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Total project costs of approximately $0.3 billion have been recorded since the restructuring was announced. The estimated costs of the total program are between $0.6 billion - $0.7 billion and is expected to be substantially completed by the end of fiscal year 2026.
The Surgery franchise restructuring cost estimate was lowered from $0.9-1.0 billion to $0.6-0.7 billion, and the completion timeline was shortened from two years (from FY2025) to end of FY2026. Total costs recorded to date are $0.3 billion. The reduction suggests the program scope was refined or certain activities were completed more efficiently than originally planned.
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Total project costs of approximately $0.6 billion have been recorded since the restructuring was announced. The estimated costs of the total program are between $0.7 billion - $0.8 billion and is expected to be substantially completed by the end of fiscal year 2025.
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Total project costs of approximately $0.8 billion have been recorded since the restructuring was announced. This program will be completed as of the fourth quarter of 2026 at a total cost of approximately $1.0 billion.
The Orthopaedics franchise restructuring cost estimate increased from $0.7-0.8 billion to approximately $1.0 billion, and the completion timeline was extended from end of FY2025 to Q4 FY2026. Costs recorded to date increased from $0.6 billion to $0.8 billion. The increase suggests the program encountered additional complexity or expanded scope.
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In May 2026, Janssen and Pharmascience Inc., Mallinckrodt PLC (now Keenova Therapeutics plc), and SpecGx LLC entered into a confidential settlement agreement. In June 2026, Janssen entered into a stipulated dismissal with Aurobindo Pharma USA, Inc. and a confidential settlement with Eugia Pharma Specialities Ltd. and Eugia US, LLC.
Janssen resolved multiple INVEGA SUSTENNA patent litigation matters in Q2 FY2026 through confidential settlements and dismissals with five generic manufacturers. These resolutions reduce litigation risk and may involve agreed-upon generic entry dates, though terms are not disclosed.
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In July 2026, the Supreme Court of Canada dismissed Pharmascience's appeal.
The Supreme Court of Canada ruled in Janssen's favor in July 2026, dismissing Pharmascience's appeal regarding the validity of Canadian Patent 2,655,335 covering INVEGA SUSTENNA. This favorable ruling strengthens Janssen's patent protection in Canada.
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Beginning in June 2025, Aragon Pharmaceuticals, Inc., Janssen Biotech, Inc., The Regents of the University of California, and Sloan-Kettering Institute for Cancer Research initiated a patent infringement lawsuit in the United States District Court for the District of New Jersey against Hetero Labs Limited Unit V and Hetero USA, Inc. who filed an ANDA seeking approval to market a 240 mg generic version of ERLEADA before the expiration of certain Orange Book Listed Patents. The following U.S. patents are included in the case: 8,445,507; 8,802,689; 9,338,159; 9,987,261; 9,481,663; 9,884,054; RE 49,353; 10,849,888; 10,702,508; 11,963,952; 12,303,493; and 12,303,497. In May 2026, the parties entered into a confidential settlement agreement, and the case was dismissed.
Janssen initiated and quickly settled ERLEADA patent litigation against Hetero in June 2025 through May 2026. The confidential settlement resolves the dispute and may establish a generic entry date, though terms are not disclosed.
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Beginning in June 2026, Aragon Pharmaceuticals, Inc., Janssen Biotech, Inc., and Sloan-Kettering Institute for Cancer Research initiated a patent infringement lawsuit in the United States District Court for the District of New Jersey against MSN Pharmaceuticals Inc., MSN Laboratories Private Limited, and Novadoz Pharmaceuticals, LLC who filed an ANDA seeking approval to market 60 mg and 240 mg generic versions of ERLEADA before the expiration of certain Orange Book Listed Patents. The following U.S. patents are included in the case: 9,481,663; 11,963,952; 12,303,493; and 12,303,497.
Janssen initiated new ERLEADA patent litigation in June 2026 against MSN and Novadoz covering both 60 mg and 240 mg generic versions. This is ongoing litigation to protect ERLEADA exclusivity.
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A trial against Sandoz Inc. took place in February 2026. Post-trial briefing is complete, and the parties await a decision from the court.
SPRAVATO patent litigation against Sandoz proceeded to trial in February 2026, with post-trial briefing now complete. A court decision is pending. The outcome will determine whether Sandoz can launch a generic version before patent expiration.
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In June 2026, Intra-Cellular, Aurobindo Pharma Ltd., and Aurobindo Pharma USA, Inc. entered into a confidential settlement agreement and the case was dismissed. Trial is scheduled to begin in March 2027 against Zydus Pharmaceuticals (USA) Inc. and Zydus Lifesciences Ltd.
Intra-Cellular (acquired by JNJ in April 2025) settled CAPLYTA patent litigation with Aurobindo in June 2026. Litigation against Zydus continues with trial scheduled for March 2027. The settlement reduces litigation risk while the Zydus case remains active.
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In January 2026, 2seventy bio, Inc. filed suit in the Unified Patent Court, Local Division of Brussels, against the Company, Janssen Biotech, Inc., Janssen Pharmaceuticals Inc., Janssen-Cilag International NV, Janssen Pharmaceutica NV, Janssen-Cilag NV, Janssen Biologics B.V., Janssen-Cilag B.V., Janssen-Cilag GmbH, Janssen-Cilag, Janssen-Cilag SpA, Janssen-Cilag A/S, Janssen-Cilag Aktiebolag, Janssen-Cilag Farmaceutica Lda., Legend Biotech Corporation, Legend Biotech USA Inc., Legend Biotech Ireland Limited, and Legend Biotech Belgium BV alleging that the manufacture and sale of CARVYKTI infringes EU Patent No. 3 689 383. In the suit, the exclusive licensee, 2seventy bio, Inc., seeks damages and an injunction. In May 2026, The United States of America, including the Department of Health and Human Services, Office of Technology Transfer, as the patent owner, intervened in the action. An oral hearing is scheduled for March 2027.
JNJ and Legend Biotech face new patent infringement litigation in Europe over CARVYKTI, with 2seventy bio seeking damages and an injunction. The U.S. government intervened as patent owner in May 2026. An oral hearing is scheduled for March 2027. This litigation could impact CARVYKTI commercialization in Europe.
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In February 2026, BIOCAD filed an unfair competition action against Genmab and Johnson & Johnson LLC in the Arbitrazh Court of Moscow Region seeking: (1) a declaration of entitlement to use the inventions claimed in Genmab’s EA Patent No. 015584 in the manufacture/marketing of their drug “Daratumia” (INN daratumumab) starting from March 24, 2026, on the basis that patent EA 015584 expires March 23, 2026; (2) a declaration that Genmab’s and Johnson & Johnson LLC’s actions in obtaining PTE extending Genmab’s EA Patent No. 037929 and sending warning letters to BIOCAD asserting infringement risks after March 24, 2026 constitute unfair competition under Article 14.8 of Law on Protection of Competition (EA 037929 has PTE until March 23, 2031); and (3) an order restraining Genmab and Johnson & Johnson LLC from creating obstacles to BIOCAD’s introduction of “Daratumia” into civil circulation starting from March 24, 2026.
BIOCAD filed an unfair competition action in Russia in February 2026 challenging JNJ's patent term extension for DARZALEX and seeking to launch a biosimilar. The case involves a patent that expired in March 2026 and a separate patent with extension to 2031. This litigation could impact DARZALEX exclusivity in Russia.
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In March 2026, Janssen Biotech, Inc. and Janssen Sciences Ireland Unlimited Company (collectively, Janssen) filed a patent infringement lawsuit in the United States District Court for the District of Delaware against Accord BioPharma, Inc. (Accord) and Bio-Thera Solutions, Ltd. in response to Accord’s filing of an aBLA seeking approval to market biosimilar versions of SIMPONI and SIMPONI ARIA and providing notice of commercial marketing pursuant to 42 U.S.C. § 262(l) (8) (A) for those biosimilar products. The following U.S. patents are currently included in that case: 8,017,325; 8,586,356; 8,852,889; 8,956,830; 9,170,249; 9,217,168; 9,475,858; 9,487,810; 9,663,810; 9,890,410; 12,129,292; 12,139,735; and 12,180,271. The following U.S. patents were dismissed without prejudice: 11,014,982; 11,041,020; 12,122,824; and 12,291,566. Janssen is seeking an order enjoining defendants from marketing their biosimilar versions of SIMPONI and SIMPONI ARIA before the expiration of the asserted patents. In May 2026, Janssen filed a motion for preliminary injunction. The court scheduled a hearing on the motion for September 2026.
Janssen initiated biosimilar litigation against Accord in March 2026 over SIMPONI and SIMPONI ARIA, asserting 13 patents. Janssen filed for preliminary injunction in May 2026 with a hearing scheduled for September 2026. This litigation seeks to delay biosimilar entry and protect SIMPONI franchise exclusivity.
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In March 2026, Accord BioPharma, Inc., Intas Pharmaceuticals Ltd., and Bio-Thera Solutions, Ltd. submitted four petitions requesting inter partes review (IPR) of U.S. patent nos. 11,014,982; 11,041,020; 12,122,824; and 12,291,566. Janssen Biotech, Inc., as the Patent Owner, has requested that the USPTO deny institution of the IPRs.
Accord and partners filed four IPR petitions in March 2026 challenging SIMPONI patents. Janssen has requested denial of institution. These IPR proceedings run parallel to the district court litigation and could invalidate key patents if successful.
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In June 2026, Janssen Biotech, Inc. and Janssen Sciences Ireland Unlimited Company (collectively, Janssen) filed a patent infringement lawsuit in the United States District Court for the Eastern District of Virginia against Alvotech hf. and Alvotech USA Inc. (Alvotech USA) in response to Alvotech USA’s filing of aBLAs seeking approval to market biosimilar versions of SIMPONI and SIMPONI ARIA and providing notice of commercial marketing pursuant to 42 U.S.C. § 262(l) (8) (A) for those biosimilar products. The following U.S. patents are included in the case: 8,017,325; 8,852,889; 8,956,830; 9,170,249; 9,217,168; 9,475,858; 9,487,810; 9,663,810; 9,890,410; 10,421,986; 11,225,516; 12,139,735; 12,534,524; and 12,595,454. Janssen is seeking an order enjoining defendants from marketing their biosimilar versions of SIMPONI and SIMPONI ARIA before the expiration of the asserted patents.
Janssen initiated a second biosimilar litigation in June 2026, this time against Alvotech, asserting 14 patents covering SIMPONI and SIMPONI ARIA. This is early-stage litigation seeking to block biosimilar entry. Multiple biosimilar challengers indicate increasing competitive pressure on the SIMPONI franchise.
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In March 2016, Abiomed, Inc. filed a declaratory judgment action against Maquet Cardiovascular LLC (Maquet) in the U.S. District Court for the District of Massachusetts seeking a declaration that certain Impella products do not infringe Maquet patents, including U.S. Patent Nos. 7,022,100 (’100 patent); 8,888,728; and 9,327,068. Maquet counterclaimed for infringement of those patents against Abiomed, Inc., Abiomed Europe GmbH, and Abiomed R&D, Inc. (collectively, Abiomed), and later added claims for infringement of U.S. Patent Nos. 9,545,468; 9,561,314; and 9,597,437. After claim construction, Maquet alleged infringement of only the ’100 patent. In September 2021, the court granted Abiomed’s motion for summary judgment of non-infringement of the ’100 patent, and in September 2023, the district court entered final judgment in favor of Abiomed on all patents-in-suit. Maquet appealed.
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In March 2016, Abiomed, Inc. filed a declaratory judgment action against Maquet Cardiovascular LLC (Maquet) in the United States District Court for the District of Massachusetts seeking a declaration that certain Impella products do not infringe Maquet patents. Maquet counterclaimed for infringement against Abiomed, Inc., Abiomed Europe GmbH, and Abiomed R&D, Inc. The following U.S. patents are at issue: 8,888,728; 9,327,068; 9,545,468; 9,561,314; and 9,597,437. In February 2026, the U.S. Court of Appeals for the Federal Circuit remanded the case after considering the district court's claim constructions. Discovery will begin based on the altered constructions.
The Federal Circuit remanded the Impella patent case in February 2026 after reviewing claim constructions, requiring new discovery. The prior period showed final judgment in Abiomed's favor on all patents. The remand reopens litigation that had been resolved favorably, creating renewed uncertainty.
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In November 2017, Maquet Cardiovascular LLC filed suit against Abiomed, Inc., Abiomed R&D, Inc., and Abiomed Europe GmbH (collectively, Abiomed) in the U.S. District Court for the District of Massachusetts, alleging that certain Impella products infringe U.S. Patent No. 9,789,238 (’238 patent). Maquet subsequently added U.S. Patent No. 10,238,783 (’783 patent). After claim construction, the court entered a stipulated judgment of non-infringement of both patents. Maquet appealed. On March 21, 2025, ... the U.S. Court of Appeals for the Federal Circuit left undisturbed the judgment on non-infringement of the ’238 patent, vacated the judgment regarding the ’783 patent, and remanded the case to the District Court for further proceedings on the ’783 patent.
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In November 2017, Maquet Cardiovascular LLC filed suit against Abiomed, Inc., Abiomed R&D, Inc., and Abiomed Europe GmbH in the United States District Court for the District of Massachusetts alleging that certain Impella products infringe Maquet patents. U.S. Patent No. 10,238,783 remains in the suit, and trial was held in May 2026. The jury returned a verdict in Abiomed's favor. Post-trial briefing is ongoing.
Following the Federal Circuit remand in March 2025, the '783 patent case proceeded to trial in May 2026. The jury returned a verdict in Abiomed's favor, a positive outcome. Post-trial briefing is ongoing. This resolves the remanded issue favorably for JNJ.
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In June 2026, three Relators filed an Amended False Claims Act Complaint in the United States District Court for the Southern District of Florida alleging the Company and DePuy Synthes, along with Tenet Healthcare Corporation, Delray Medical Center, and West Boca Medical Center caused the submission of false claims to federal and Florida healthcare programs. The Relators are sales representatives for competitor companies, and the complaint was served following a decision by the Department of Justice to decline intervening in the case. The Company and DePuy Synthes disagree with and are defending themselves against these claims.
A new False Claims Act complaint was filed in June 2026 against JNJ and DePuy Synthes by competitor sales representatives, alleging false claims to federal and Florida healthcare programs. The DOJ declined to intervene. This is early-stage qui tam litigation that JNJ is defending.
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In July 2016, the Company and Janssen Products, LP were served with a qui tam complaint pursuant to the False Claims Act filed in the United States District Court for the District of New Jersey alleging the off-label promotion of two HIV products, PREZISTA and INTELENCE, and anti-kickback violations in connection with the promotion of these products. The complaint was filed under seal in December 2012. The federal and state governments have declined to intervene, and the lawsuit is being prosecuted by the relators. The Court denied summary judgment on all claims in December 2021. Daubert motions were granted in part and denied in part in January 2022, and trial commenced in May 2024. On June 13, 2024, a jury found no liability regarding the anti-kickback violations but found liability for a portion of the off-label promotion claims. The Company is pursuing post-trial briefing challenging the verdict on the off-label claims. On March 28, 2025, the Court granted in part and denied in part Janssen’s motions and the Company is appealing the verdict and judgments. The Company filed a notice of appeal with the Third Circuit on April 29, 2025. Briefing is ongoing.
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In July 2016, the Company and Janssen Products, LP were served with a qui tam complaint pursuant to the False Claims Act filed in the United States District Court for the District of New Jersey alleging the off-label promotion of two HIV products, PREZISTA and INTELENCE, and anti-kickback violations in connection with the promotion of these products. The complaint was filed under seal in December 2012. The federal and state governments have declined to intervene, and the lawsuit is being prosecuted by the relators. The court denied summary judgment on all claims in December 2021. Daubert motions were granted in part and denied in part in January 2022, and trial commenced in May 2024. In June 2024, a jury found no liability regarding the anti-kickback violations but found liability for a portion of the off-label promotion claims. The Company challenged the verdict on the off-label claims in post-trial briefing. In March 2025, the court dismissed the state law portion of the claims but entered judgment on the federal claims. The Company appealed the remainder of the verdict to the Third Circuit. The federal government has intervened for the limited purpose of defending the qui tam provision of the False Claims Act. Briefing is complete and oral argument was held in March 2026. A decision is pending. In April 2026, the Third Circuit ordered the parties to engage in mediation.
The PREZISTA/INTELENCE qui tam appeal progressed through oral argument in March 2026, and the Third Circuit ordered mediation in April 2026. The prior period showed briefing ongoing. The mediation order suggests the court is encouraging settlement discussions, which could resolve the matter without a full appellate decision.
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In March 2017, Janssen Biotech, Inc. (JBI) received a Civil Investigative Demand from the United States Department of Justice regarding a False Claims Act investigation concerning management and advisory services provided to rheumatology and gastroenterology practices that purchased REMICADE or SIMPONI ARIA. In August 2019, the United States Department of Justice notified JBI that it was closing the investigation. Subsequently, the United States District Court for the District of Massachusetts unsealed a qui tam False Claims Act complaint, which was served on the Company. The Department of Justice had declined to intervene in the qui tam lawsuit in August 2019. The Company filed a motion to dismiss, which was granted in part and denied in part. Discovery is underway.
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In March 2017, Janssen Biotech, Inc. (JBI) received a Civil Investigative Demand from the United States Department of Justice (DOJ) regarding a False Claims Act investigation concerning management and advisory services provided to rheumatology and gastroenterology practices that purchased REMICADE or SIMPONI ARIA. In August 2019, the DOJ notified JBI that it was closing the investigation. Subsequently, the United States District Court for the District of Massachusetts unsealed a qui tam False Claims Act complaint, which was served on the Company. The DOJ had declined to intervene in the qui tam lawsuit in August 2019. The Company filed a motion to dismiss, which was granted in part and denied in part. The court heard argument on the parties’ summary judgment motions in May 2026, but has not yet issued a decision. The court has scheduled a trial date in November 2026.
The REMICADE qui tam case progressed to summary judgment argument in May 2026, with a trial date scheduled for November 2026. The prior period showed discovery underway. The case is advancing toward trial, increasing near-term litigation risk and potential exposure.
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In October 2017, certain United States service members and their families brought a complaint against a number of pharmaceutical and medical devices companies, including Johnson & Johnson and certain of its subsidiaries in United States District Court for the District of Columbia, alleging that the defendants violated the United States Anti-Terrorism Act. The complaint alleges that the defendants provided funding for terrorist organizations through their sales practices pursuant to pharmaceutical and medical device contracts with the Iraqi Ministry of Health. In July 2020, the District Court dismissed the complaint. In January 2022, the United States Court of Appeals for the District of Columbia Circuit reversed the District Court’s decision. In June 2023, defendants filed a petition for a writ of certiorari to the United States Supreme Court. In June 2024, the Supreme Court vacated the D.C. Circuit's decision and remanded the case to the D.C. Circuit. Oral argument was held in November 2024.
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In October 2017, certain United States service members and their families brought a complaint against a number of pharmaceutical and medical devices companies, including the Company and certain of its subsidiaries in the United States District Court for the District of Columbia, alleging that the defendants violated the United States Anti-Terrorism Act. The complaint alleges that the defendants provided funding for terrorist organizations through their sales practices pursuant to pharmaceutical and medical device contracts with the Iraqi Ministry of Health. In July 2020, the district court dismissed the complaint. In January 2022, the United States Court of Appeals for the District of Columbia Circuit reversed the district court’s decision. In June 2024, the Supreme Court vacated the D.C. Circuit's decision and remanded the case to the D.C. Circuit for reconsideration. In January 2026, the D.C. Circuit affirmed its reversal of the district court's dismissal of the complaint. In April 2026, the D.C. Circuit denied the defendants' rehearing petition.
Following Supreme Court remand, the D.C. Circuit reaffirmed its reversal in January 2026 and denied rehearing in April 2026. The case now returns to the district court for proceedings on the merits. This adverse appellate outcome means the case will proceed, increasing litigation risk and potential exposure under the Anti-Terrorism Act.
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In February 2024, a putative class action was filed against the Company and the Pension & Benefits Committee of Johnson & Johnson (Committee) in United States District Court for the District of New Jersey. The complaint alleges that defendants breached fiduciary duties under the Employee Retirement Income Security Act (ERISA) by allegedly mismanaging the Company’s prescription-drug benefits program. The complaint seeks damages and other relief. In January 2025, the Court granted in part and denied in part defendants’ motion to dismiss, with leave to replead. In March 2025, plaintiffs filed a second amended complaint. In April 2025, defendants filed a motion to dismiss plaintiffs' fiduciary duty claims.
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In February 2024, a putative class action was filed against the Company and the Pension & Benefits Committee of Johnson & Johnson in the United States District Court for the District of New Jersey. The complaint alleges that defendants breached fiduciary duties under the Employee Retirement Income Security Act (ERISA) by allegedly mismanaging the Company’s prescription-drug benefits program. The complaint seeks damages and other relief. In March 2025, plaintiffs filed a second amended complaint. In November 2025, the court granted defendants' motion to dismiss plaintiffs' fiduciary duty claims. Plaintiffs voluntarily withdrew their remaining claim, and the court entered final judgment in defendants' favor in January 2026. Plaintiffs appealed to the United States Court of Appeals for the Third Circuit.
The ERISA prescription drug benefits case was dismissed in JNJ's favor in November 2025, with final judgment entered in January 2026. Plaintiffs appealed to the Third Circuit. The prior period showed the case in motion-to-dismiss stage. The dismissal is a favorable outcome, though the appeal creates some residual risk.
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In October 2020, Fortis Advisors LLC (Fortis), in its capacity as representative of the former stockholders of Auris Health Inc. (Auris), filed a complaint against the Company, Ethicon Inc., and certain named officers and employees (collectively, Ethicon) in the Court of Chancery of the State of Delaware. The complaint alleges breach of contract, fraud, and other causes of action against Ethicon in connection with Ethicon’s acquisition of Auris in 2019. The complaint seeks damages and other relief. In December 2021, the Court granted in part and denied in part defendants’ motion to dismiss certain causes of action. All claims against the individual defendants were dismissed. The trial occurred in January 2024. In September 2024, the court found liability with respect to certain claims and no liability with respect to other claims. The Company has appealed the decision.
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In October 2020, Fortis Advisors LLC, as representative of the former stockholders of Auris Health Inc. (Auris), filed a complaint against the Company alleging breach of contract, fraud, and other causes of action in connection with Ethicon’s acquisition of Auris in 2019. In January 2026, the Company paid a $0.8 billion judgment, inclusive of interest.
JNJ paid a $0.8 billion judgment in January 2026 related to the Auris acquisition litigation, inclusive of interest. The prior period showed the Company had appealed the September 2024 liability finding. The payment suggests the judgment was enforceable pending appeal, representing a significant cash outflow.
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In October 2019, Innovative Health, LLC filed a complaint against Biosense Webster, Inc (BWI) in the United States District Court for the Central District of California. The complaint alleges that certain of BWI's business practices and contractual terms violate the antitrust laws of the United States and the State of California by restricting competition in the sale of High Density Mapping Catheters and Ultrasound Catheters. In May 2025, a jury returned its verdict in favor of Innovative Health. Innovative Health is seeking a permanent injunction. BWI intends to appeal once the judgment is final.
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In October 2019, Innovative Health, LLC filed a complaint against Biosense Webster, Inc. (BWI) in the United States District Court for the Central District of California. The complaint alleges that certain of BWI's business practices and contractual terms violate the antitrust laws of the United States and the State of California by restricting competition in the sale of High Density Mapping Catheters and Ultrasound Catheters. In May 2025, a jury returned its verdict in favor of Innovative Health. In August 2025, the court issued a permanent injunction concerning BWI's business practices. BWI appealed both the jury verdict and the permanent injunction. In June 2026, briefing of the appeal was completed.
The Biosense Webster antitrust case progressed through permanent injunction issuance in August 2025 and appeal briefing completion in June 2026. The prior period showed the jury verdict with injunction pending. The permanent injunction restricts BWI's business practices, and the appeal is now fully briefed awaiting decision.
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In October 2018, two separate putative class actions were filed against Actelion Pharmaceutical Ltd., Actelion Pharmaceuticals U.S., Inc. and Actelion Clinical Research, Inc. (collectively Actelion) in United States District Court for the District of Maryland and United States District Court for the District of Columbia. The complaints allege that Actelion violated state and federal antitrust and unfair competition laws by allegedly refusing to supply generic pharmaceutical manufacturers with samples of TRACLEER. TRACLEER is subject to a Risk Evaluation and Mitigation Strategy required by the U.S. Food and Drug Administration, which imposes restrictions on distribution of the product. In January 2019, the plaintiffs dismissed the District of Columbia case and filed a consolidated complaint in the United States District Court for the District of Maryland. In September 2024, the district court granted plaintiff's motion for class certification. Trial is scheduled for March 2026.
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In October 2018, two separate putative class actions were filed against Actelion Pharmaceuticals Ltd., Actelion Pharmaceuticals US, Inc. and Actelion Clinical Research, Inc. (collectively, Actelion) in the United States District Court for the District of Maryland and the United States District Court for the District of Columbia. The complaints allege that Actelion violated state and federal antitrust and unfair competition laws by allegedly refusing to supply generic pharmaceutical manufacturers with samples of TRACLEER. TRACLEER is subject to a Risk Evaluation and Mitigation Strategy required by the U.S. Food and Drug Administration, which imposes restrictions on distribution of the product. In January 2019, the plaintiffs dismissed the District of Columbia case and filed a consolidated complaint in the United States District Court for the District of Maryland. In September 2024, the district court granted plaintiffs' motion for class certification. In February 2026, the parties agreed to settle the matter. In July 2026, the court granted final approval of the settlement.
The TRACLEER antitrust class action was settled in February 2026 with final court approval in July 2026. The prior period showed trial scheduled for March 2026. The settlement resolves the matter, eliminating trial risk, though settlement terms are not disclosed.
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In December 2023, a putative class action lawsuit was filed against the Company and Janssen Biotech Inc. (collectively Janssen) in the United States District Court for the Eastern District of Virginia. The complaint alleges that Janssen violated federal and state antitrust laws and other state laws by delaying biosimilar competition with STELARA through Janssen's enforcement of patent rights covering STELARA. The complaint seeks damages and other relief. In February 2024, plaintiffs filed an amended complaint, which Janssen moved to dismiss in March 2024. In August 2024, the court granted in part and denied in part Janssen's motion to dismiss.
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In December 2023, a putative class action lawsuit was filed against the Company and Janssen Biotech Inc. (collectively, Janssen) in the United States District Court for the Eastern District of Virginia. The complaint alleges that Janssen violated federal and state antitrust laws and other state laws by delaying biosimilar competition with STELARA through Janssen's enforcement of patent rights covering STELARA. The complaint seeks damages and other relief. In August 2024, the court granted in part and denied in part Janssen's motion to dismiss plaintiffs' amended complaint. In December 2025, the court granted plaintiffs' motion for class certification. In January 2026, the court granted summary judgment for Janssen on plaintiffs' claim regarding patents obtained through the acquisition of Momenta Pharmaceuticals, Inc. in 2020. In March 2026, plaintiffs appealed to the United States Court of Appeals for the Fourth Circuit.
The STELARA antitrust case progressed through class certification in December 2025 and partial summary judgment in Janssen's favor in January 2026 on Momenta-related patents. Plaintiffs appealed in March 2026. The prior period showed motion-to-dismiss stage. The partial summary judgment is favorable, though the case continues on other claims and the appeal is pending.
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In August 2025, Xoma Corporation (Xoma) filed a complaint against Janssen Biotech, Inc. (Janssen) in the United States District Court for the Eastern District of Pennsylvania. The complaint alleges breach of contract, unjust enrichment, and declaratory relief claims against Janssen regarding the alleged failure to obtain a license from Xoma in connection with Janssen's commercialization of TREMFYA. In December 2025, the court denied Janssen's motion to dismiss.
Xoma filed a breach of contract lawsuit in August 2025 alleging Janssen failed to obtain a required license for TREMFYA commercialization. The court denied Janssen's motion to dismiss in December 2025. This is early-stage litigation that could result in damages or licensing obligations related to TREMFYA.
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Beginning in March 2021, Janssen Pharmaceuticals, Inc., Bayer Pharma AG, Bayer AG and Bayer Intellectual Property GmbH filed patent infringement lawsuits in United States district courts against generic manufacturers who have filed ANDAs seeking approval to market generic versions of XARELTO before expiration of certain Orange Book Listed Patents. The following entities are named defendants: Dr. Reddy’s Laboratories, Inc.; Dr. Reddy’s Laboratories, Ltd.; Lupin Limited; Lupin Pharmaceuticals, Inc.; Taro Pharmaceutical Industries Ltd.; Taro Pharmaceuticals U.S.A., Inc.; Teva Pharmaceuticals USA, Inc.; Mylan Pharmaceuticals Inc.; Mylan Inc.; Mankind Pharma Limited; Apotex Inc.; Apotex Corp.; Cipla Ltd.; Cipla USA Inc.; and InvaGen Pharmaceuticals, Inc. The following U.S. patents are included in one or more cases: 9,539,218 and 10,828,310. U.S. Patent No. 10,828,310 was also under consideration by the USPTO in an IPR proceeding. In July 2023, the USPTO issued a final written decision finding the claims of the patent invalid. In September 2023, Bayer Pharma AG filed an appeal to the U.S. Court of Appeals for the Federal Circuit. Oral argument was heard in May 2025.
XARELTO patent litigation disclosure was removed from the current filing. The prior period described ongoing litigation against multiple generic manufacturers and an IPR appeal heard in May 2025. The removal suggests these matters may have been resolved or are no longer considered material to disclose, though no explicit resolution is stated.
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Beginning in September 2020, Janssen Pharmaceuticals, Inc., Janssen Pharmaceutica NV, and Janssen Research & Development, LLC filed patent infringement lawsuits in United States district courts against generic manufacturers who have filed ANDAs seeking approval to market generic versions of INVEGA TRINZA before expiration of the Orange Book Listed Patent. The following entities are named defendants: Mylan Laboratories Limited; Mylan Pharmaceuticals Inc.; and Mylan Institutional LLC. The following U.S. patent is included in one or more cases: 10,143,693. In May 2023, the District Court issued a decision finding that Mylan’s proposed generic product infringes the asserted patent and that the patent is not invalid. Mylan appealed the decision, and in March 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the district court's decision. In May 2025, Mylan filed a petition for panel rehearing or rehearing en banc with the U.S. Court of Appeals for the Federal Circuit. In July 2025, the court denied Mylan's petition.
INVEGA TRINZA patent litigation disclosure was removed from the current filing. The prior period showed the Federal Circuit affirmed Janssen's victory in March 2025 and denied Mylan's rehearing petition in July 2025. The removal is a lifecycle removal — the litigation concluded favorably for Janssen with no further appeals, so the disclosure is no longer current news.
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Beginning in January 2024, Janssen Inc. and Mitsubishi Tanabe Pharma Corporation initiated Statements of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against generic manufacturers who filed ANDSs seeking approval to market generic versions of INVOKANA before expiration of the listed patents. The following entities are named defendants Jamp Pharma Corporation (Jamp) and Apotex Inc. (Apotex). The following Canadian patents are included in one or more cases 2,534,024 and 2,671,357. The Company entered into confidential settlement agreements with Jamp, in April 2025, and with Apotex, in July 2025.
INVOKANA Canadian patent litigation disclosure was removed from the current filing. The prior period showed confidential settlements with both defendants (Jamp in April 2025, Apotex in July 2025). The removal is a lifecycle removal — the litigation was fully resolved through settlements, so the disclosure is no longer current news.
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Beginning in March 2024, Intra-Cellular Therapies, Inc. (Intra-Cellular) filed patent infringement lawsuits in the United States District Court for the District of New Jersey against generic manufactures who have filed ANDAs seeking approval to market generic versions of CAPLYTA before expiration of certain Orange Book Listed Patents. The following entities are named defendants: Aurobindo Pharma Ltd., Aurobindo Pharma USA, Inc., Alkem Laboratories Ltd., Dr. Reddy’s Laboratories Inc., Dr. Reddy’s Laboratories Ltd., Hetero USA, Inc., Hetero Labs Ltd. Unit-V, Hetero Labs Ltd., MSN Laboratories Private Ltd., Zydus Pharmaceuticals (USA) Inc., and Zydus Lifesciences Ltd. The following U.S. Patents are included in one or more cases: US RE 48,825; RE 48,839; 8,648,077; 9,168,258; 9,199,995; 9,616,061; 9,956,227; 10,117,867; 10,464,938; 10,960,009; 11,026,951; 11,753,419; 11,980,617; 12,070,459; 12,090,155; 12,122,792; and 12,128,043. In July 2025, Intra-Cellular, Hetero USA, Inc., Hetero Labs Ltd. Unit-V, and Hetero Labs Ltd. entered into a confidential settlement agreement.
The CAPLYTA litigation disclosure in the current filing omits the Hetero settlement that was disclosed in the prior period (July 2025). However, the current filing does disclose the Aurobindo settlement (June 2026) and ongoing litigation against Zydus. The omission of the Hetero settlement is likely a lifecycle removal — it was disclosed when fresh in the prior period, and is now integrated history.
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In July 2023, the DOJ issued Civil Investigative Demands to the Company, Johnson & Johnson Surgical Vision, Inc., and Johnson & Johnson Vision Care, Inc. (collectively, J&J Vision) in connection with a civil investigation under the False Claims Act relating to free or discounted intraocular lenses and equipment used in eye surgery, such as phacoemulsification and laser systems. J&J Vision has provided documents and information responsive to the Civil Investigative Demands and is continuing to cooperate with the DOJ regarding its inquiry.
The J&J Vision DOJ investigation disclosure was removed from the current filing. The prior period showed the investigation was ongoing with document production and cooperation. The removal suggests the investigation may have been closed or is no longer considered material to disclose, though no explicit resolution is stated.
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The Company or its subsidiaries are also parties to various proceedings brought under the Comprehensive Environmental Response, Compensation, and Liability Act, commonly known as Superfund, and comparable state, local or foreign laws in which the primary relief sought is the Company’s agreement to implement remediation activities at designated hazardous waste sites or to reimburse the government or third parties for the costs they have incurred in performing remediation at such sites.
The generic Superfund and environmental proceedings disclosure was removed from the current filing. This was boilerplate language describing the Company's exposure to environmental remediation proceedings. The removal suggests these matters are no longer considered material to disclose individually, though environmental liabilities may still exist.
Financial Statements
Primary statements as printed on the EDGAR filing (iXBRL face). Companyfacts is used only when a statement is not on the HTML face. Not generated by the model.
Consolidated Statements of Operations (Unaudited)
| Description | Q2 ended Jun 28, 2026 | Q2 ended Jun 29, 2025 |
|---|---|---|
| Revenue: | ||
| Total revenue / net sales | 25,310 | 23,743 |
| Cost of revenue / cost of sales | 8,051 | 7,628 |
| Gross profit | 17,259 | 16,115 |
| Operating expenses: | ||
| Research and development | 3,653 | 3,516 |
| Selling, general and administrative | 6,432 | 5,889 |
| Interest expense | 281.0 | 308.0 |
| Other income/(expense), net | (331.0) | (107.0) |
| Income before income taxes | 6,747 | 6,491 |
| Income tax expense/(benefit) | 1,213 | 954.0 |
| Net income | 5,534 | 5,537 |
| Basic earnings per share | 2.30 | 2.30 |
| Diluted earnings per share | 2.27 | 2.29 |
consolidated balance sheets (Unaudited)
(Unaudited; Dollars in Millions Except Share and Per Share Data)
| Description | June 28, 2026 | December 28, 2025 |
|---|---|---|
| Assets | ||
| Current assets: | ||
| Cash and cash equivalents (Note 4) | 20,422 | 19,709 |
| Marketable securities | 336 | 393 |
| Accounts receivable, trade, less allowances $171 (2025, $183) | 19,046 | 17,178 |
| Inventories (Note 2) | 15,144 | 14,191 |
| Prepaid expenses and other | 4,826 | 4,153 |
| Total current assets | 59,774 | 55,624 |
| Property, plant and equipment at cost | 55,518 | 54,364 |
| Less: accumulated depreciation | (31,936) | (31,195) |
| Property, plant and equipment, net | 23,582 | 23,169 |
| Intangible assets, net (Note 3) | 48,229 | 50,403 |
| Goodwill (Note 3) | 48,479 | 48,772 |
| Deferred taxes on income (Note 5) | 6,728 | 6,874 |
| Other assets | 14,269 | 14,368 |
| Total assets | 201,061 | 199,210 |
| Liabilities and shareholders’ equity | ||
| Current liabilities: | ||
| Loans and notes payable | 11,692 | 8,495 |
| Accounts payable | 9,223 | 11,991 |
| Accrued liabilities | 9,464 | 8,594 |
| Accrued rebates, returns and promotions | 19,990 | 19,124 |
| Accrued compensation and employee related obligations | 3,475 | 4,534 |
| Accrued taxes on income (Note 5) | 1,051 | 1,388 |
| Total current liabilities | 54,895 | 54,126 |
| Long-term debt (Note 4) | 37,344 | 39,438 |
| Deferred taxes on income (Note 5) | 6,608 | 6,791 |
| Employee related obligations (Note 6) | 6,657 | 6,957 |
| Long-term taxes payable (Note 5) | 485 | 486 |
| Other liabilities | 10,101 | 9,868 |
| Total liabilities | 116,090 | 117,666 |
| Commitments and Contingencies (Note 11) | ||
| Shareholders’ equity: | ||
| Common stock par value $1.00 per share (authorized 4,320,000,000 shares; issued 3,119,843,000 shares) | 3,120 | 3,120 |
| Accumulated other comprehensive income (loss) (Note 7) | (13,951) | (14,930) |
| Retained earnings and Additional paid-in capital | 171,665 | 168,978 |
| Less: common stock held in treasury, at cost (711,615,000 and 711,904,000 shares) | 75,863 | 75,624 |
| Total shareholders’ equity | 84,971 | 81,544 |
| Total liabilities and shareholders’ equity | 201,061 | 199,210 |
consolidated statements of cash flows (Unaudited)
(Unaudited; Dollars in Millions)
| Description | Fiscal six months ended June 28, 2026 | Fiscal six months ended June 29, 2025 |
|---|---|---|
| Cash flows from operating activities | ||
| Net earnings | 10,769 | 16,536 |
| Adjustments to reconcile net earnings to cash flows from operating activities: | ||
| Depreciation and amortization of property and intangibles | 3,963 | 3,715 |
| Stock based compensation | 758 | 698 |
| Asset write-downs | 220 | 30 |
| Charges for acquired in-process research and development assets | 2 | 92 |
| Net loss/(gain) on sale of assets/businesses | (43) | (74) |
| Deferred tax provision | (320) | 2,997 |
| Credit losses and accounts receivable allowances | (12) | 3 |
| Changes in assets and liabilities, net of effects from acquisitions and divestitures: | ||
| Increase in accounts receivable | (1,947) | (2,283) |
| Increase in inventories | (1,002) | (656) |
| Decrease in accounts payable and accrued liabilities | (956) | (886) |
| Decrease/(Increase) in other current and non-current assets | 1,299 | (6,194) |
| Decrease in other current and non-current liabilities | (1,601) | (5,926) |
| Net cash flows from operating activities | 11,130 | 8,052 |
| Cash flows used for investing activities | ||
| Additions to property, plant and equipment | (2,370) | (1,838) |
| Proceeds from the disposal of assets/businesses, net (Note 10) | 92 | 332 |
| Acquisitions, net of cash acquired (Note 10) | (263) | (14,458) |
| Acquired in-process research and development assets / related milestones (Note 10) | — | (369) |
| Purchases of investments | (299) | (431) |
| Sales of investments | 368 | 953 |
| Credit support agreements activity, net | 515 | (2,684) |
| Other (including capitalized licenses and milestones) | (193) | (66) |
| Net cash used for investing activities | (2,150) | (18,561) |
| Cash flows (used for) from financing activities | ||
| Dividends to shareholders | (6,358) | (6,118) |
| Repurchase of common stock | (4,249) | (2,127) |
| Proceeds from short-term debt, net | 13,146 | 9,349 |
| Repayment of short-term debt, net | (9,677) | (5,058) |
| Proceeds from long-term debt, net of issuance costs | — | 9,138 |
| Repayment of long-term debt | (2,003) | (754) |
| Proceeds from the exercise of stock options/employee withholding tax on stock awards, net | 1,531 | 557 |
| Credit support agreements activity, net | (49) | (271) |
| Other | (588) | 41 |
| Net cash (used for) from financing activities | (8,247) | 4,757 |
| Effect of exchange rate changes on cash and cash equivalents | (20) | 224 |
| Increase in cash and cash equivalents | 713 | (5,528) |
| Cash and cash equivalents, beginning of period | 19,709 | 24,105 |
| Cash and cash equivalents, end of period | 20,422 | 18,577 |
Face scale: (Unaudited; Dollars in Millions Except Share and Per Share Data); (Unaudited; Dollars in Millions). Amounts in millions USD; EPS as reported. Statements found on the EDGAR/iXBRL face print as filed; the rest are presentation-friendly mappings of filer XBRL tags. Use EDGAR for interactive notes and detail. Interactive statements & notes on EDGAR ↗
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Figures/quotes linked to EDGAR · Narrative written by AI · Jul 24, 2026 · How we verify