MORRISVILLE – A federal patent ruling against Liquidia could restrict the market availability of YUTREPIA, the Morrisville-based biopharmaceutical company’s lead product, while the final judgment and remedy remain pending.
The U.S. District Court for the District of Delaware ruled that claims 1 and 14 of United Therapeutics’ U.S. Patent No. 11,826,327 are valid and infringed by Liquidia. Those claims generally cover treating pulmonary hypertension associated with interstitial lung disease, or PH-ILD, with inhaled treprostinil, including dry-powder formulations.
The court found the other four asserted claims invalid. It directed the parties to submit a proposed form of judgment, including proposed remedies, within one week.
Liquidia said it disagrees with the decision and plans to pursue available appellate options. The company also said it intends to ask the U.S. Food and Drug Administration to remove the PH-ILD indication from YUTREPIA’s label.
The remedy has not been decided. Liquidia said potential outcomes could range from removing the PH-ILD indication to broader restrictions on YUTREPIA’s market availability. United Therapeutics has asked for injunctive relief that could restrict the product’s availability.
Reuters reported that Liquidia shares fell nearly 50% after the ruling, putting the company on track to lose about $3.18 billion in market value based on the trading move. Reuters described the decision as a major challenge to YUTREPIA’s commercial outlook.
YUTREPIA is a dry-powder formulation of treprostinil approved in 2025 for pulmonary arterial hypertension and PH-ILD. Liquidia, headquartered in Morrisville, said uncertainty around appeals and further proceedings prevents it from reasonably estimating the financial exposure.
The immediate North Carolina business consequence is a new legal risk to the lead product of a Triangle-headquartered public biotechnology company. The court has ruled on infringement, but the judgment, remedy, any appeal and any FDA label change remain unresolved.
Featured image: Official Liquidia corporate logo. Credit: Liquidia.