- Jury awarded USD 884,943,990 in single damages in AMITIZA (lubiprostone) antitrust trial; wholesaler portion USD 474,897,965 and retailers USD 346,837,646, both subject to statutory trebling.
- Consolidated suits since 2021 target three Takeda entities, alleging the 2014 settlement with Sucampo and Par was anticompetitive.
- The 2014 settlement permitted Par to launch an authorized generic on January 1, 2021, over six years before patent expiry and 17 months before Par's ANDA approval.
- Takeda terminated its Sucampo collaboration on March 31, 2024, no longer markets AMITIZA, will appeal, assess a provision for FY2025 and revise filings; FY2026 guidance not expected to be materially impacted except for adjusted free cash flow.
Jury verdict and damages
A U.S. jury returned a verdict against Takeda in the AMITIZA (lubiprostone) antitrust trial, awarding USD 884,943,990 in single damages; the wholesaler award was USD 474,897,965 and individual retailers USD 346,837,646, both subject to statutory trebling, while end-payor damages remain subject to further court proceedings.
Allegations and settlement background
The consolidated suits, filed since 2021 against three Takeda entities, allege a 2014 settlement between Takeda and Sucampo with Par Pharmaceutical was anticompetitive; that agreement permitted Par to launch an authorized generic on January 1, 2021, more than six years before patent expiry and 17 months before Par’s ANDA approval.
Product and commercial status
AMITIZA, approved by the U.S. FDA in 2006 for chronic idiopathic constipation in adults, is no longer sold or marketed by Takeda following termination of its collaboration and license agreement with Sucampo effective March 31, 2024.
Next steps and financial reporting impact
Takeda will pursue post-trial motions and an appeal, is assessing the provision to recognize in consolidated FY2025 (fiscal year ended March 31, 2026), will record a subsequent-event provision and re-file revised FY2025 consolidated financials and reports as required, expects no impact on FY2025 Core results, and does not expect FY2026 guidance to be materially affected except potentially for adjusted free cash flow dependent on payment amount and timing.
