Jury Verdict in U.S. Antitrust Litigation Relating to AMITIZA® (lubiprostone) and Revision of Related Financial Results for the Fiscal Year Ending March 2026 (FY2025)
Takeda Pharmaceutical Company Limited, Takeda Pharmaceuticals U.S.A., Inc., and Takeda Pharmaceuticals America, Inc.
AMITIZA® (lubiprostone), which was sold in the United States
The plaintiffs alleged that the settlement agreement entered into in 2014 by Takeda and Sucampo Pharmaceuticals, Inc. to resolve patent infringement litigation with Par Pharmaceutical, Inc. was anticompetitive. Takeda believes that the plaintiffs' claims are without merit.
Related procedures
Jury verdict, post-verdict motions and appeals in U.S. antitrust litigation
U.S. District Court for the District of Massachusetts
A putative class of wholesalers, a putative class of third-party payors, and individual retail pharmacy plaintiffs
Takeda Pharmaceutical Company Limited, Takeda Pharmaceuticals U.S.A., Inc., and Takeda Pharmaceuticals America, Inc.
The jury found actual damages (single damages) of US$884,943,990, comprising US$474,897,965 for the wholesaler class and US$346,837,646 in total for the individual retail pharmacies. The damages awarded to the wholesaler class and the individual retail pharmacies will automatically be trebled upon entry of judgment. The final amount for the third-party payor class may be adjusted through additional proceedings.
The provision amount is currently under review and has not been determined. Once the amount has been determined, Takeda plans to recognize the provision in its consolidated financial statements for FY2025. FY2025 Core results will not be affected.
The consolidated financial statements for the fiscal year ending March 2026 (FY2025). The provision is expected to be recognized as a subsequent event relating to circumstances that existed as of 31 March 2026.
The forecasts and management guidance for FY2026 are not expected to be materially affected. However, the adjusted free cash flow forecast may be affected depending on the amount and timing of payment. Once the review has been completed, Takeda plans to revise its FY2026 forecasts and management guidance as necessary.
Company response
Sales and marketing of AMITIZA. Takeda's collaboration and license agreement with Sucampo Pharmaceuticals, Inc. relating to AMITIZA ended on 31 March 2024, and Takeda does not currently sell or market AMITIZA.
Takeda will contest the matter through all available legal means, including post-verdict motions and appeals. Takeda will review the provision amount and, once it has been determined, revise its consolidated financial statements for FY2025, revised earnings releases and other FY2025 financial materials as soon as reasonably possible.
Once the provision amount has been determined, Takeda plans to file a revised earnings release and other materials as soon as reasonably possible. Once the review has been completed, Takeda plans to revise its FY2026 forecasts and management guidance as necessary.
| Item | Details |
|---|---|
| Event name | Jury Verdict in U.S. Antitrust Litigation Relating to AMITIZA® (lubiprostone) and Revision of Related Financial Results for the Fiscal Year Ending March 2026 (FY2025) |
| Date of occurrence | 18 May 2026 (U.S. Eastern Time; date of the jury verdict) |
| Subject Entity | Takeda Pharmaceutical Company Limited, Takeda Pharmaceuticals U.S.A., Inc., and Takeda Pharmaceuticals America, Inc. |
| Target Locations / Products | AMITIZA® (lubiprostone), which was sold in the United States |
| Cause | The plaintiffs alleged that the settlement agreement entered into in 2014 by Takeda and Sucampo Pharmaceuticals, Inc. to resolve patent infringement litigation with Par Pharmaceutical, Inc. was anticompetitive. Takeda believes that the plaintiffs' claims are without merit. |
| Amount of Impact on Business Performance | The provision amount is currently under review and has not been determined. Once the amount has been determined, Takeda plans to recognize the provision in its consolidated financial statements for FY2025. FY2025 Core results will not be affected. |
| Accounting period in which recognized | The consolidated financial statements for the fiscal year ending March 2026 (FY2025). The provision is expected to be recognized as a subsequent event relating to circumstances that existed as of 31 March 2026. |
| Impact on Earnings Forecast | The forecasts and management guidance for FY2026 are not expected to be materially affected. However, the adjusted free cash flow forecast may be affected depending on the amount and timing of payment. Once the review has been completed, Takeda plans to revise its FY2026 forecasts and management guidance as necessary. |
| Type of litigation or proceeding | Jury verdict, post-verdict motions and appeals in U.S. antitrust litigation |
| Court or authority | U.S. District Court for the District of Massachusetts |
| Plaintiff | A putative class of wholesalers, a putative class of third-party payors, and individual retail pharmacy plaintiffs |
| Defendant | Takeda Pharmaceutical Company Limited, Takeda Pharmaceuticals U.S.A., Inc., and Takeda Pharmaceuticals America, Inc. |
| Date of filing / date of action | 18 May 2026 (U.S. Eastern Time; date of the jury verdict). The litigation was filed from 2021 onward, but the specific filing date is Not disclosed. |
| Claim amount / surcharge amount | The jury found actual damages (single damages) of US$884,943,990, comprising US$474,897,965 for the wholesaler class and US$346,837,646 in total for the individual retail pharmacies. The damages awarded to the wholesaler class and the individual retail pharmacies will automatically be trebled upon entry of judgment. The final amount for the third-party payor class may be adjusted through additional proceedings. |
| Suspended operations | Sales and marketing of AMITIZA. Takeda's collaboration and license agreement with Sucampo Pharmaceuticals, Inc. relating to AMITIZA ended on 31 March 2024, and Takeda does not currently sell or market AMITIZA. |
| Outlook | Takeda will contest the matter through all available legal means, including post-verdict motions and appeals. Takeda will review the provision amount and, once it has been determined, revise its consolidated financial statements for FY2025, revised earnings releases and other FY2025 financial materials as soon as reasonably possible. |
| Planned follow-up disclosure | Once the provision amount has been determined, Takeda plans to file a revised earnings release and other materials as soon as reasonably possible. Once the review has been completed, Takeda plans to revise its FY2026 forecasts and management guidance as necessary. |
Items this document does not state (8)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.A jury returned an unfavorable verdict in litigation in which the plaintiffs alleged that the settlement agreement entered into in 2014 by Takeda and Sucampo Pharmaceuticals, Inc. to resolve patent infringement litigation with Par Pharmaceutical, Inc. was anticompetitive. Takeda plans to revise its FY2025 financial results once the amount has been determined, as it may be necessary to recognize a provision for matters relating to events that existed as of 31 March 2026.