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UTC can't counterclaim over amended Liquidia drug application, US judge says

By Melissa Ritti ( May 5, 2025, 15:57 GMT | Insight) -- A US judge on Friday refused to reach intervenor United Therapeutics Corp.'s counterclaims that the US Food and Drug Administration ran afoul of the Administrative Procedure Act when it allowed Liquidia to amend its new drug application for Yutrepia in order to include a new indication. In a holding worth noting for drugmakers, the court said deprivation of the 30-month period of exclusivity UTC might have otherwise enjoyed if Liquidia was instead required to file a new NDA does not constitute an injury-in-fact under Article III of the US Constitution. The decision comes as UTC reports a 25 percent year-over-year spike in sales for its Tyvaso hypertension drug series.The US Food and Drug Administration and Liquidia Technologies on Friday defeated counterclaims by intervenor United Therapeutics Corp. over the agency’s allowance of an amended new drug application, or NDA, for Yutrepia, a treprostinil inhalation powder....

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