Takeda Pharmaceutical Company said a U.S. federal jury has returned a verdict against the company in long-running antitrust litigation involving constipation drug AMITIZA, awarding plaintiffs nearly $885 million in damages while the pharmaceutical company prepares post-trial motions and an appeal.
The verdict, delivered on May 18 in the U.S. District Court for the District of Massachusetts, stems from allegations that Takeda and former partner Sucampo Pharmaceuticals entered into an anticompetitive agreement in 2014 related to generic competition for AMITIZA (lubiprostone), a prescription medicine approved to treat chronic idiopathic constipation in adults.
According to Takeda, the jury awarded total single damages of $884.9 million to multiple plaintiff groups, including wholesalers, retailers and end payors. Under U.S. antitrust law, however, substantial portions of the award are expected to automatically increase because of statutory trebling provisions.
The wholesaler class received approximately $474.9 million in single damages, while individual retailer plaintiffs were awarded about $346.8 million. These categories will automatically be tripled upon entry of judgment, potentially raising Takeda’s exposure significantly. Damages awarded to the end payor class remain subject to further proceedings and may still be adjusted before final judgment is entered.
Takeda emphasized that the jury decision is not yet enforceable because judgment has not formally been entered by the court. The company added that the ultimate financial liability remains uncertain as post-trial proceedings continue.
The litigation dates back to 2021, when several antitrust lawsuits were filed against three Takeda-owned corporate entities: Takeda Pharmaceutical Company Limited, Takeda Pharmaceuticals U.S.A., Inc. and Takeda Pharmaceuticals America, Inc. The lawsuits were consolidated in Massachusetts federal court and include claims brought by wholesalers, third-party payors and individual retailers.
Plaintiffs alleged that a patent settlement agreement signed in 2014 between Takeda, Sucampo Pharmaceuticals and generic drugmaker Par Pharmaceutical improperly delayed generic competition for AMITIZA.
Takeda disputed those claims, arguing that the agreement was negotiated at arm’s length and complied with the U.S. Hatch-Waxman regulatory framework governing branded and generic pharmaceuticals. The company said the settlement permitted Par Pharmaceutical to launch an authorized generic version of AMITIZA beginning January 1, 2021—more than six years before relevant patents expired and roughly 17 months before approval of Par’s own abbreviated new drug application.
Additional generic entrants later entered the market under licensed timelines, according to the company.
AMITIZA, known generically as lubiprostone, received approval from the U.S. Food and Drug Administration in 2006 for chronic idiopathic constipation treatment in adults. Takeda noted that its collaboration and licensing agreement with Sucampo ended in March 2024 and that the company no longer markets or sells the product.
In a statement following the ruling, Takeda said it strongly disagrees with the jury’s findings and believes both evidentiary and legal errors occurred during trial. The company said it intends to vigorously pursue post-trial motions and appeal the decision.
Financially, Takeda said it is assessing what legal provision must be recognized in consolidated financial statements for the fiscal year ended March 31, 2026. The company expects to revise and refile certain FY2025 financial materials after completing its assessment. However, Takeda said the ruling will not affect its FY2025 core financial results and does not expect a material impact on FY2026 financial guidance, except for potential adjustments to free cash flow depending on the timing and amount of any eventual payment.