Liquidia Corp. (LQDA) announced on Monday that the U.S. District Court for the District of Delaware, presided over by Judge Andrews, denied United Therapeutics' (UTHR) motion for a preliminary injunction. This motion, filed last Friday, sought to halt the launch of Liquidia's YUTREPIA (treprostinil) inhalation powder, a treatment for pulmonary hypertension associated with interstitial lung disease (PH-ILD).
This decision supports a clear path for the U.S. Food and Drug Administration (FDA) to make a final decision on the amended New Drug Application (NDA) for YUTREPIA.
United Therapeutics filed the motion in a lawsuit initiated in September 2023, claiming that YUTREPIA would infringe on U.S. Patent No. 11,826,32.
While this ruling preserves the current situation, where there are no legal barriers preventing the FDA from granting final approval for YUTREPIA, the lawsuit will proceed to trial, currently scheduled for June 2025.
Additionally, United Therapeutics has appealed Judge Andrews' previous decision to lift an injunction that had blocked the launch of YUTREPIA based solely on the '793 Patent.
