Liquidia Corporation announced that on May 31, Judge Andrews of the U.S. District Court for the District of Delaware (District Court) denied the motion for preliminary injunction filed by United Therapeutics (UTHR) that sought to block the launch of Liquidia?s YUTREPIA? (treprostinil) inhalation powder to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD). The ruling reinforces the clear path for the U.S. Food and Drug Administration (FDA) to issue a final decision on the amended New Drug Application (NDA) for YUTREPIA.

The motion for preliminary injunction was filed in the lawsuit (Case No. 23-975) filed by UTHR in September 2023 in which it has alleged YUTREPIA would infringe U.S. Patent No. 11,826,327 (?327 patent).

While this ruling maintains the status quo in which there is no legal impediment to the FDA granting final approval to YUTREPIA, this lawsuit will continue forward to trial, which is currently scheduled for June 2025. Friday?s ruling follows earlier legal rulings from multiple bodies finding that YUTREPIA does not infringe any valid claim of the patents previously asserted by UTHR, including the decision by the Patent Trial and Appeal Board, affirmed by the U.S. Court of Appeals for the Federal Circuit (Federal Circuit), that all claims of U.S. Patent No. 10,716,793 (?793 Patent) to be unpatentable.

UTHR has stated that it plans to appeal the Federal Circuit?s affirmation of the invalidity of the ?793 Patent to the United States Supreme Court. Separately, UTHR has also appealed Judge Andrews? ruling to set aside an injunction that he had previously issued blocking the launch of YUTREPIA based solely on the ?793 Patent.

YUTREPIA is an investigational, inhaled dry powder formulation of treprostinil delivered through a convenient, low-effort, palm-sized device. The FDA previously issued tentative approval of YUTREPIA for the PAH indication in November 2021. YUTREPIA was designed using Liquidia?s PRINT® technology, which enables the development of drug particles that are precise and uniform in size, shape, and composition, and that are engineered for enhanced deposition in the lung following oral inhalation.

Liquidia has completed INSPIRE, or Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil, an open-label, multi-center phase 3 clinical study of YUTREPIA in patients diagnosed with PAH who are naïve to inhaled treprostinil or who are transitioning from Tyvaso® (nebulized treprostinil). YUTREPIA is currently being studied in the ASCENT trial, an Open-Label Prospective Multicenter Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in Pulmonary Hypertension, with the objective of informing YUTREPIA?s dosing and tolerability profile in patients with PH-ILD. YUTREPIA was previously referred to as LIQ861 in investigational studies.