EQS-Adhoc: Takeda Pharmaceutical Company Limited: Takeda Provides an Update regarding Jury Verdict in AMITIZA® (lubiprostone) Antitrust Litigation in the U.S. and Related Revision to FY2025 Financial Results

News Release

Takeda Provides an Update regarding Jury Verdict in AMITIZA^®
(lubiprostone) Antitrust Litigation in the U.S. and Related Revision to
FY2025 Financial Results
 

OSAKA, Japan and CAMBRIDGE, Massachusetts, May 18, 2026 - Takeda (TSE:4502/NYSE:TAK) today announced that on May 18, 2026 (U.S. Eastern Time), a jury in the U.S. District Court for the District of Massachusetts returned a verdict against Takeda in the AMITIZA^® (lubiprostone) antitrust litigation and awarded plaintiffs USD 884,943,990 in single damages. Under U.S. antitrust law, the damages awarded to the wholesaler class (USD 474,897,965 in single damages) and individual retailers (collectively USD 346,837,646 in single damages) will be automatically trebled upon entry of judgment. The damages awarded to the end payor class are subject to further proceedings prior to entry of judgment. Takeda will vigorously pursue post-trial motions and an appeal.

Since 2021, several antitrust actions have been filed against three Takeda owned corporate entities (Takeda Pharmaceutical Company Limited, Takeda Pharmaceuticals U.S.A., Inc., and Takeda Pharmaceuticals America, Inc.) in the U.S. District Court for the District of Massachusetts. The pending case consolidates actions filed by a putative class of wholesalers, a putative class of third-party payors, and individual retailer plaintiffs. The plaintiffs collectively allege that a settlement that Takeda and Sucampo Pharmaceuticals, Inc. (“Sucampo”) entered into in 2014 with Par Pharmaceutical, Inc. (“Par”) to resolve patent litigation claims related to Par’s generic formulation of AMITIZA was anticompetitive.

The settlement agreement resolved patent litigation through an arms-length negotiation process, which was consistent with the Hatch-Waxman framework. The settlement agreement specifically allowed Par to launch an authorized generic on January 1, 2021, more than six years before patents covering AMITIZA would have expired and seventeen months before Par’s own Abbreviated New Drug Application was approved. Other generic entrants followed pursuant to their licensed entry dates. AMITIZA is a prescription medicine approved by the U.S. Food and Drug Administration in 2006 for the treatment of chronic idiopathic constipation in adults. Takeda’s collaboration and license agreement with Sucampo related to AMITIZA was terminated as of March 31, 2024, and Takeda no longer sells or markets AMITIZA.

Takeda stated: “We remain firm in our conviction that the plaintiffs’ case lacks merit, and we will vigorously pursue post-trial motions and an appeal. We also believe that there were both evidentiary and legal errors made during the trial. While we are disappointed with this outcome, we thank the jury for its service.”

The jury’s verdict is not enforceable until the court enters judgment at a later date, and the amount of any liability that may ultimately be imposed on Takeda has not yet been finalized. Under U.S. antitrust law, the damages awarded to the wholesaler class and the individual retailers are subject to statutory trebling; however, the final amount of damages awarded to the end payor class may still be adjusted in connection with additional court proceedings prior to the entry of judgment.

Takeda is currently assessing the amount of the provision to be recognized in its consolidated financial statements for the fiscal year ended March 31, 2026 (FY2025) in relation to this matter. Once that amount is determined, Takeda will, as soon as practicable, record a provision as a subsequent event that relates to a condition that existed as of March 31, 2026, revise its FY2025 consolidated financial statements, and re-file a revised FY2025 Earnings Report with the Tokyo Stock Exchange and revise other FY2025 financial materials reflecting the impact of the provision in due course. This outcome will not have any impact on Takeda’s FY2025 Core financial results.

Takeda does not expect its FY2026 financial forecast or Management Guidance to be materially impacted, except for the adjusted free cash flow forecast, depending upon the amount and timing of any payment.
We will revise the FY2026 financial forecast and Management Guidance, as necessary, once our assessment is completed.

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

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Investor Relations

Christopher O’Reilly

Christopher.oreilly@takeda.com

+81(0)90-6481-3412

Media Contacts

Media Relations

Media_Relations@takeda.com

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2329834  19-May-2026 CET/CEST