US jury to decide if Takeda delayed generic constipation drug

Takeda Pharmaceutical

14/05/2026 19:54

Jury to decide if patent settlement delayed generic Amitiza, raising costs for buyers

Plaintiffs allege Takeda owes hundreds of millions of dollars in damages

Takeda argues settlement was legal, patents were strong, and deal increased competition

By Nate Raymond

BOSTON, May 14 (Reuters) - A federal jury in Boston is set to decide whether Takeda Pharmaceutical 4502.T should pay hundreds of millions of dollars in damages for what plaintiffs described as an antitrust scheme that delayed the release of a cheaper, generic version of its anti-constipation drug Amitiza.

     After five weeks of trial, jurors are set to begin deliberations on Friday after hearing closing arguments in lawsuits by pharmacies, insurers, health funds and retailers including CVS and Walgreens who allege they were overcharged for the drug due to an antitrust conspiracy Takeda joined.

Only three other such cases have gone to trial and reached a verdict in the 13 years since the U.S. Supreme Court held that deals between brand-name drug companies and generic rivals that delay the launch of cheaper medicines can violate antitrust law.

Such reverse payment or pay-for-delay agreements have been the subject of numerous lawsuits in the years since by the Federal Trade Commission and private litigants, yet most have been dismissed or settled before reaching a jury.

The lawsuits in Boston were filed beginning in 2021 by plaintiffs representing direct and indirect purchasers of Amitiza in class action lawsuits as well as large, individual retailers suing on their own behalf.

The drug was developed by Sucampo Pharmaceuticals, which partnered with Takeda to market and sell it in the United States after the treatment received the U.S. Food and Drug Administration's approval in 2006.

'PAYOFF TO STAY OFF'

In 2012, Par Pharmaceutical sought FDA approval to bring a generic version of Amitiza to market. Sucampo and Takeda sued, alleging patent infringement, and Par countered that the patents covering the drug were invalid.

The companies reached a settlement in 2014 under which Par would not bring a generic product to market until January 2021, when it could sell an authorized generic version of Amitiza, known as lubiprostone, supplied by Sucampo pursuant to a 50-50 profit split.

Lawyers for the plaintiffs in their closing arguments on Thursday said the agreement constituted an illegal "payoff" worth about $210 million that gave Par a lucrative partnership with Sucampo, which Mallinckrodt acquired in 2018, while causing generic drug competition to be delayed by six years.

"It’s a payoff to stay off," said Jonathan Stratton, a lawyer at Sperling Kenny Nachwalter representing five retailers including CVS and Walgreens who say they were overcharged by $527 million.

Thomas Sobol, a lawyer for a class of pharmacies and other direct drug purchasers, said "the core, immovable truth is Takeda, Sucampo and Par conspired with each other to delay generic competition and keep prices high."

Sobol, a lawyer at the law firm Hagens Berman Sobol Shapiro, said the scheme damaged his clients by as much as $759.5 million. The health plans, or so-called end-payors, are meanwhile seeking up to $103.5 million in damages, according to a slide their lawyer showed jurors.

Any damages the jury awards would be subject to automatic tripling under federal antitrust law, potentially exposing Takeda to a multi-billion dollar judgment.

Joshua Barlow, one of Takeda's lawyers, told jurors that the settlement had been lawful and pro-competition, saying without it, generic Amitiza would still not be available because the final patents for the drug do not expire until October 2027.

"It was a good settlement," Barlow, a lawyer at Arnold & Porter Kaye Scholer, said. "It increased competition."

He said the patents covering the drug were strong, and that after a judge delivered a ruling in the litigation between the companies that construed key patent terms in a way unfavorable to Par, "it was never going to be able to defeat them."

Takeda proceeded to trial alone in the antitrust litigation, after the plaintiffs dropped their claims against Par after its parent company, Endo International, filed for bankruptcy in 2022.

The case is In re Amitiza Antitrust Litigation, U.S. District Court for the District of Massachusetts, No. 1:21-cv-11057.

For the direct purchaser class: Thomas Sobol and Kristen Johnson of Hagens Berman Sobol Shapiro

For the retailers: Jonathan Stratton of Sperling Kenny Nachwalter

For the end-payor class: Uriel Rabinovitz of Lowey Dannenberg

For Takeda: Joshua Barlow of Arnold & Porter Kaye Scholer

(Reporting by Nate Raymond in Boston)