Takeda faces ‘pay-for-delay’ class-action suit over anti-constipation drug
Takeda Pharmaceuticals is the target of a proposed class action that alleges the pharma giant paid to keep a generic anti-constipation drug off the market.
The complaint filed by KPH Healthcare Services in the US District Court for the District of Massachusetts on Tuesday, August 3, claimed that Takeda paid drug manufacturer Par to keep a generic of its Amitiza (lubiprostone) anti-constipation drug off the market.
“The deal preserved Amitiza’s monopoly, and with it Amitiza’s monopoly profits which were shared between Takeda and Par (now owned by Endo),” said the suit.
KPH Healthcare Services (and subsidiary Kinney) claimed the deal was struck in 2014, shortly after the patent for the active ingredient in Amitiza, lubiprostone, expired.
Since then, at least six companies have filed applications to market and sell an Amitiza generic, but could not enter the market as Par was the first company to seek generic approval.
Par’s parent company Endo International announced that it had begun shipping the first authorised generic versions of Amitiza in January 2021.
KPH brings the class-action lawsuit on behalf of all purchasers of the Amitiza and Par’s authorised generic over the six years since the alleged deal.
For this, KPH and Kinney are asking the Massachusetts court to award class damages at an amount to be determined at court and a trial by jury.
Antitrust crackdown
Last week, the US Senate Judiciary voted to pass four bills that aim to crack down on anti-competitive pharmaceutical practices, giving the Federal Trade Commission more power to deny pay-for-delay deals.
Specifically, the Preserving Access to Affordable Generics and Biosimilars Act targets deals between drug developers and follow-on drug developers to delay the entry of generics into the market.
The next step for the four bills will be a vote before the full Senate and then onto the House of Representatives.
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