Takeda faces $885m hit after landmark pay-for-delay lawsuit verdict

Takeda has been ordered to pay $885m – potentially rising to $2.5bn – after a landmark court case verdict found the Japanese pharma company liable for a conspired arrangement to keep market monopoly of its constipation drug Amitiza (lubiprostone).

A jury in the US District Court for the District of Massachusetts found Takeda liable in a pay-for-delay litigation. This anticompetitive tactic involves a pharmaceutical company paying a generic rival to hold off marketing a copycat drug in return for financial compensation. It is the first time a federal jury has found a drugmaker liable in a pay-for-delay case.

The lawsuit was filed by wholesalers, retail pharmacies, and end payers in 2021, claiming they had been overpaying for Amitiza. Retail giants CVS and Walgreens were among those suing Takeda. In the eyes of the jury, Takeda was found to have entered into an anticompetitive agreement with generic drugmaker Par Pharma, which stopped a cheaper version of the drug from reaching the market.

As per Takeda, damages to wholesalers amount to $475m, while individual retailers are being awarded $347m. These will be automatically trebled once the final recording of the court’s decision is made, meaning the final figure could rise to around $2.5bn.

In a statement following the decision, Takeda confirmed it would appeal the outcome.

The company said: “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.”

Reacting to the proceedings, Citi analysts stated: “The amount of damages remains undetermined until the district court delivers its final judgment, and even if Takeda were to lose the district court case, we would expect it to appeal and the litigation to continue.”

Amitiza was approved in the US in 2006 for the treatment of chronic idiopathic constipation (CIC) in adults. As its core patent expiries approached in 2017, Takeda and its partner Sucampo Pharmaceuticals negotiated a $210m settlement with Par Pharmaceuticals in 2014. The agreement saw Par delay the market entry of its generic referencing Amitiza until 2021. Peak sales for Takeda’s drug came in the late-2010s, when it generated around $500m anually, according to GlobalData’s Pharma Intelligence Centre. Takeda no longer sells Amitiza after the expiry of its license agreement with Sucampo in March 2024.

GlobalData is the parent company of Pharmaceutical Technology.

The court’s verdict comes at a time of significant change for Takeda. Earlier this week, the drugmaker revealed that it plans to cut about 4,500 jobs in fiscal 2026 as part of restructuring efforts. It expects annual savings of more than $1.27bn by fiscal 2028.

“Takeda faces $885m hit after landmark pay-for-delay lawsuit verdict” was originally created and published by Pharmaceutical Technology, a GlobalData owned brand.

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