Liquidia Corporation (NASDAQ:LQDA), a biopharmaceutical company driven by science and compassion to revolutionize care for patients with challenging respiratory and vascular diseases, today announced that it has entered into a global settlement agreement with United Therapeutics Corporation (NASDAQ:UTHR) that resolves all pending litigation between the companies. Importantly, YUTREPIA® (treprostinil) inhalation powder will remain available to patients with PAH without disruption.
Liquidia CEO Dr. Roger Jeffs said: "We are always guided by our commitment to act in the best interests of patients in everything we do. Today’s agreement fully resolves years of litigation and provides certainty to PAH patients that they can continue to access YUTREPIA, whose differentiated attributes have enabled its rapid adoption by physicians and patients since launch. We can now focus our full attention and resources on further growing the YUTREPIA brand, with the goal of making it the prostacyclin therapy of choice in PAH, whether patients are starting or switching from an inhaled therapy, transitioning from an oral prostacyclin, or de-escalating from parenteral prostacyclin to inhaled. And simultaneously, we will continue to build on our market position through post-marketing studies of YUTREPIA, pivotal studies of L606 to support PAH and PH-ILD indications, and new studies to explore novel treatments for conditions like systemic sclerosis-associated Raynaud's phenomenon (SSc-RP) and pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD), where no approved options exist."
Litigation Fully Resolved
The settlement follows the September 30, 2026, ruling by the U.S. District Court for the District of Delaware (the Court) that claims 1 and 14 of U.S. Patent No. 11,826,327 (the ’327 patent) are valid and infringed by Liquidia. These claims generally cover treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) with inhaled treprostinil, including dry powder formulations. As part of the settlement, Liquidia has agreed not to appeal the Court’s ruling. In addition, Liquidia has submitted a supplement to remove the PH-ILD indication from YUTREPIA’s label and no longer promotes it for PH-ILD.
The settlement includes mutual releases and is not an admission of liability by either party. Following Liquidia’s initial payment, the parties will file stipulations to dismiss with prejudice the following matters as between UTHR and Liquidia:
- United Therapeutics Corporation v. Liquidia Technologies, Inc., C.A. No. 1:23-cv-00975 (D. Del.), related to alleged infringement of the ’327 patent;
- United Therapeutics Corporation v. Liquidia Technologies, Inc., C.A. No. 1:25-cv-00368 (M.D.N.C.), related to alleged infringement of U.S. Patent No. 11,357,782;
- Liquidia Technologies, Inc. v. United Therapeutics Corporation, C.A. No. 1:25-cv-00299 (M.D.N.C.), related to alleged infringement of U.S. Patent No. 10,898,494;
- United Therapeutics Corporation and Lung Biotechnology PBC v. Liquidia Technologies, Inc. and Robert Roscigno, No. 21CVS004094-310 (N.C. Super. Ct.), related to alleged misappropriation of trade secrets;
- United Therapeutics Corporation and Lung Biotechnology PBC v. Robert Roscigno and Liquidia Technologies, Inc., No. 24CVS3755 (N.C. Super. Ct.), related to alleged breach of contract; and
- Sandoz Inc. and RareGen, LLC v. United Therapeutics Corporation and Smiths Medical ASD, Inc., No. 2:19-cv-1070 (D.N.J.), and the related appeals, Nos. 24-3067, 24-3116 and 24-3146 (3d Cir.), related to alleged antitrust violations.