Jury Hits Takeda Over Amitiza Deal, Opening Door to Multi-Billion Dollar Antitrust Blow

A federal jury in Boston has delivered a costly verdict against Japanese drugmaker Takeda Pharmaceutical Company, concluding that the company used an unlawful strategy to keep cheaper versions of its constipation medicine Amitiza off the U.S. market for years.

The panel found Takeda responsible for roughly $885 million in damages after siding with wholesalers, insurers, pharmacies and major retailers that argued they were forced to pay inflated prices because generic competition was delayed. Among the companies involved in the lawsuit were CVS Health and Walgreens.

The ruling could ultimately become far more expensive. Under U.S. antitrust law, much of the award may be automatically tripled, potentially pushing the financial hit beyond $2 billion.

At the center of the case was Amitiza, a treatment originally developed by Sucampo Pharmaceuticals and marketed in the United States through a partnership with Takeda after the drug received approval in 2006.

The dispute traces back to 2012, when Par Pharmaceutical moved to launch a generic version of the drug. Takeda and Sucampo responded with patent litigation, accusing the company of infringement. Two years later, the sides settled.

Plaintiffs argued that the 2014 agreement was effectively a “pay-for-delay” arrangement — a type of patent settlement critics say allows branded drugmakers to buy time by rewarding generic rivals for postponing cheaper alternatives. According to the lawsuit, the deal allowed Par to hold off launching a competing version until January 2021 while still benefiting from a profit-sharing arrangement tied to an authorized generic form of the medicine, lubiprostone.

Lawyers representing drug purchasers described the arrangement as a massive financial payoff that preserved Takeda’s market exclusivity for nearly six extra years.

Takeda, however, maintained throughout the trial that the agreement was lawful and actually accelerated competition rather than suppressing it. The company said it plans to challenge the verdict on appeal, arguing that legal and evidentiary mistakes affected the outcome of the trial.

The decision is being closely watched across the pharmaceutical industry because it marks the first time a jury has ruled against a drugmaker in a class-action “pay-for-delay” antitrust case since the U.S. Supreme Court opened the door to such challenges in 2013. Earlier jury trials involving similar allegations had all ended in victories for pharmaceutical companies.

The jury split damages across several categories of plaintiffs. Direct purchasers, including wholesalers and pharmacies, were awarded nearly $475 million. Insurers and other end payors received more than $63 million. Separate claims brought by retailers resulted in another $346 million in awards, including about $191 million for CVS and roughly $121 million for Walgreens.

Takeda’s commercial relationship involving Amitiza ended in 2024, and the company no longer markets the drug.

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