UTC Sues Liquidia to Block FDA Approval of Yutrepia Until 2026

Sept. 6, 2023, 5:23 PM UTC

United Therapeutics Corp. launched a fresh campaign to block Liquidia Corp.’s Yutrepia, alleging its amended bid for approval of its treatment for high blood pressure in the lungs—a rival to UTC’s Tyvaso—“warrants an automatic 30-month stay of approval.”

Liquidia told UTC in a July 24 letter that it had submitted an amendment of its new drug application to the US Food and Drug Administration that “describes a modification to the original application,” a move that required Liquidia to certify that it believes UTC’s patent is invalid, unenforceable, or won’t be infringed by Yutrepia, according to a complaint filed Tuesday ...

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