Takeda said a U.S. jury awarded plaintiffs $884.9 million in damages in AMITIZA antitrust litigation alleging delayed generic competition, with portions of the award subject to automatic trebling under U.S. antitrust law.
By: Regulatory Desk
Takeda Pharmaceutical Company said a jury in the U.S. District Court for the District of Massachusetts returned a verdict on May 18, 2026 (U.S. Eastern Time) in litigation concerning its constipation drug AMITIZA (lubiprostone), awarding plaintiffs $884.9 million in single damages.
According to the company, the award included approximately $474.9 million for the wholesaler class and $346.8 million for individual retailers. Damages related to the end payor class remain subject to additional proceedings and will be determined before final judgment.
Under U.S. antitrust law, damages awarded to wholesalers and retailers are typically trebled when final judgment is entered, meaning those amounts could increase substantially.
Plaintiffs allege that Takeda and Sucampo Pharmaceuticals entered into an anticompetitive settlement with Par Pharmaceutical that delayed generic competition for AMITIZA. Takeda maintains that the settlement was negotiated at arm’s length under the Hatch–Waxman framework and permitted Par to launch an authorized generic version of AMITIZA on January 1, 2021, years before patent expiry and before final approval of Par’s abbreviated new drug application.
Takeda added that it stopped marketing AMITIZA after its collaboration and license agreement with Sucampo ended on March 31, 2024. The company said it disagrees with the verdict, believes the claims lack merit, and plans to pursue post-trial motions and an appeal, arguing that evidentiary and legal errors occurred during trial.
The company also noted that the verdict is not enforceable until the court enters final judgment and that the final liability amount could still change depending on end-payor proceedings and the outcome of any appeal.
Takeda is currently assessing any financial provision that may need to be recognized in its consolidated financial statements for the fiscal year ended March 31, 2026, and expects to revise and re-file its FY2025 earnings materials after completing that assessment.
The company said the verdict will not affect its FY2025 core financial results and does not currently expect a material impact on FY2026 guidance, although adjusted free cash flow could be affected depending on the timing and amount of any eventual payment.
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