According to Liquidia, the company has reached a settlement with United Therapeutics to end all litigation related to patent infringement by Liquidia’s Yutrepia treprostinil DPI. A United States District Court judge recently ruled that Yutrepia infringed on a United Therapeutics patent protecting Tyvaso inhaled treprostinil, leading Liquidia to announce that it would submit an sNDA to remove the PH-ILD indication from the Yutrepia NDA.
The company says that the sNDA has now been submitted, and the settlement will allow the company to continue marketing Yutrepia for PAH without interruption. In addition to giving up marketing the DPI for the PH-ILD indication and ending litigation, Liquidia reports that the deal includes a $175 million payment now to United Therapeutics plus an additional $145.4 million to be paid in two installments by the end of April 2027. An additional $60.3 million will go to parties who were involved in litigation related to injected Treprostinil.
Liquidia CEO Roger Jeffs commented, “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.”
Jeffs added that the company will continue to conduct post-marketing studies of Yutrepia and pivotal studies of L606 liposomal treprostinil inhalation suspension for both indications. Liquidia acquired North American rights to L606 from Pharmosa Biopharm in 2023. He said that Liquidia would also continue developing Yutrepia for systemic sclerosis-associated Raynaud’s phenomenon (SSc-RP) and pulmonary hypertension associated with COPD.
Read the Liquidia press release
