Takeda reaches settlement with drug wholesalers over alleged pay-for-delay scheme for Colcrys

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Takeda, the Japanese pharmaceutical giant, has reached a settlement in an antitrust case that has been looming over the company. The lawsuit, which spanned approximately two years, involved allegations of anti-competitive practices related to Takeda’s gout medication, Colcrys.

The settlement was reached with drug wholesalers who had accused Takeda of employing anti-competitive agreements to delay the entry of generic versions of Colcrys into the market. Specific details regarding the settlement terms were not disclosed, and Takeda has declined to comment on the matter.

The lawsuit originated when a consortium of wholesalers, including prominent entities such as AmerisourceBergen, filed antitrust claims in a federal court in Pennsylvania in August 2021. Central to the case were patent settlements that Takeda had forged in 2015 and 2016 with several generic drug manufacturers concerning their versions of generic Colcrys.

One of the defendants, Par Pharmaceutical (a subsidiary of Endo), opted to produce an authorised generic version of Colcrys, paying Takeda royalties instead of marketing its own product, as alleged by the plaintiffs. The other generic drug manufacturers also delayed their product launches for several years, as outlined in the complaint.

Takeda received FDA approval for Colcrys as a standalone treatment for acute gout flares in 2009, even though the active ingredient, colchicine, had been widely available. Prior to Colcrys, multiple sellers offered colchicine products at low prices, according to the plaintiffs.

However, due to the patent agreements, Takeda managed to maintain a dominant position in the market until Mylan entered in 2019. The wholesalers contended that they paid prices that were inflated by 1,200% compared to what they should have been in the absence of such agreements. Meanwhile, Colcrys’ annual sales soared to as high as $546 million.

Notably, the Colcrys case is one of at least three pay-for-delay lawsuits involving Takeda or its acquired company, Shire, in recent years. In 2017, an antitrust class action alleged that Shire’s patent settlement with Actavis concerning the ADHD drug Intuniv was anti-competitive. Shortly before the Colcrys lawsuit in 2021, Takeda and Par faced a similar lawsuit accusing them of delaying generic competition for the constipation drug Amitiza. At the close of 2022, a federal judge in Massachusetts declined Takeda’s motion to dismiss that case.

This resolution marks a significant development in Takeda’s efforts to address legal challenges related to its business practices, highlighting the ongoing scrutiny of antitrust issues in the pharmaceutical industry.

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