Liquidia Corporation Provides Update on Litigation Filed by United Therapeutics

Core Viewpoint - Liquidia Corporation is facing a patent infringement lawsuit from United Therapeutics Corporation regarding the commercialization of its inhalation powder YUTREPIA™ for treating pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease [1][6] Group 1: Legal Proceedings - United Therapeutics filed a complaint on May 9, 2025, in the U.S. District Court for the Middle District of North Carolina, alleging infringement of U.S. Patent No. 11,357,782 [1] - The lawsuit seeks to prevent Liquidia from commercializing YUTREPIA™ if it receives FDA approval [1][6] - The '782 patent claims the same general method of administering inhaled treprostinil as the previously invalidated '793 patent, which was deemed unpatentable due to prior art [2][6] Group 2: FDA Approval Timeline - The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of May 24, 2025, for the final action on the New Drug Application (NDA) for YUTREPIA [3][6] - United Therapeutics is not seeking an injunction against the FDA to prevent the approval of YUTREPIA [3] Group 3: Company Overview - Liquidia Corporation is focused on developing innovative therapies for patients with rare cardiopulmonary diseases, including pulmonary hypertension [4] - The company’s lead candidate, YUTREPIA™, is an investigational drug utilizing its proprietary PRINT Technology [4]