A jury awarded nearly $885 million in damages to pharmacies and wholesalers alleging that a Takeda settlement illegally kept generic competition off the market for Amitiza. The case involved class-action litigation over a constipation drug. Takeda had partnered with Sucampo for development and commercialization, later terminating the partnership in 2024 and stopping sales. Earlier, Takeda settled patent litigation with Par Pharmaceutical, paying Par while Par agreed to delay market entry until 2021. The payments were characterized as reverse payments or “pay for delay.” Takeda argued the settlement followed the Hatch-Waxman Act and allowed a 2021 authorized generic launch before patent expiration and before Par’s abbreviated new drug application approval. Federal antitrust damages may be tripled after final judgment, potentially exceeding $2.6 billion.
"Five years of class-action litigation over a Takeda Pharmaceutical gastrointestinal drug culminated this week in a jury awarding nearly $885 million in damages to pharmacies and wholesalers who had alleged that one such settlement illegally kept generic competition from entering the market."
"Under federal antitrust law, damages are automatically tripled. That would put Takeda on the hook for more than $2.6 billion. The case concerns the constipation drug Amitiza. The twice-daily capsule was developed by Sucampo Pharmaceuticals."
"Under the terms of Takeda's settlement with Par, Takeda paid Par and the generic drugmaker agreed to keep its drug off the market until 2021. Such payments are called reverse payments because money flows from the branded company to the generic one. The practice has also been described as "pay for delay" as these payments essentially postpone the launch of generic competition."
"Takeda contends its settlement was consistent with the framework of the Hatch-Waxman Act, the 1984 law that created a framework for generic drugs in the U.S. The pharma company also says the agreement permitted a 2021 launch of Par's authorized generic in 2021, which was six years before Amitiza's patents expired and 17 months before Par's own abbreviated new drug application was approved."
#antitrust-law #pharmaceutical-settlements #generic-drug-competition #hatch-waxman-act #pay-for-delay
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