Takeda settles antitrust lawsuit over gout drug Colcrys after trial kicked off

21 Sep 2023
www.fiercepharma.com
Patent InfringementDrug ApprovalBiosimilar
Takeda settles antitrust lawsuit over gout drug Colcrys after trial kicked off
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Source: FiercePharma
The Colcrys case is one of at least three pay-for-delay lawsuits Takeda has faced in the past several years.
Takeda has managed to close one of the antitrust cases that have been hanging over the company.
The Japanese pharma giant has inked a settlement with drug wholesalers who accused the company of using anti-competitive deals to delay generic entry to its gout drug Colcrys, a court filing shows.
The exact terms of the deal were unclear. Takeda declined to comment.
The lawsuit lasted for about two years. A group of wholesalers, including big names such as AmerisourceBergen, filed the antitrust claims in federal court in Pennsylvania in August 2021. The case centers on patent settlements that Takeda reached in 2015 and 2016 with several generic drug manufacturers around their generic versions of Colcrys.
Other defendants in the lawsuit include Endo’s Par Pharmaceutical, Amneal and Teva, through its acquisition of Watson Laboratories.
Rather than selling its own product, Par agreed to make an authorized generic Colcrys by paying Takeda royalties, according to the plaintiffs. The other generic players also delayed their launches for several years, the complaint shows.
Takeda won FDA approval in 2009 for Colcrys as a standalone drug for treating acute flares of gout. Its active ingredient, colchicine, has long been widely available. Before Colcrys, at least 21 sellers marketed colchicine products “for pennies,” the plaintiffs said.
But because of its patent deals, Takeda managed to dominate the market until Mylan entered in 2019, the wholesalers said. The plaintiffs said they paid prices that were 1,200% higher than they should have otherwise been. In the meantime, Colcrys’ annual sales climbed as high as $546 million.
Colcrys is one of at least three pay-for-delay lawsuits Takeda or its acquired company Shire have faced in recent years. In 2017, an antitrust class action claimed Shire’s patent settlement with Actavis around the ADHD drug Intuniv was anticompetitive.
Shortly before the Colcrys suit in 2021, Takeda and Par were hit by a similar lawsuit accusing the two of delaying generic competition to constipation drug Amitiza. At the end of 2022, a federal judge in Massachusetts rejected Takeda’s motion to dismiss the case.
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