Liquidia Corporation (LQDA), a biopharmaceutical company, Monday said that United Therapeutics Corporation (UTHR) has filed a patent infringement complaint against Liquidia.
The patent in question was issued in June 2022 to United Therapeutics for its treprostinil inhalation powder branded as Tyvaso DPI, which was approved by the U.S. Food and Drug Administration (FDA) for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) in May 2022.
Additionally, the complaint seeks to prevent Liquidia from commercializing its YUTREPIA (treprostinil) inhalation powder if approved by the FDA to treat PAH and PH-ILD.
In August 2024, the FDA had tentatively approved YUTREPIA to treat adults with PAH and PH-ILD. However, the final approval is delayed until after the expiration of 3-year regulatory exclusivity for Tyvaso DPI on May 23, 2025.
Liquidia noted that United Therapeutics is not seeking any injuction against the FDA to prevent the approval of YUTREPIA, for which the regulator had given a Prescription Drug User Fee Act (PDUFA) goal date of May 24, 2025.
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