Liquidia has agreed to pay approximately $380.7 million to United Therapeutics and other parties to resolve a yearslong legal conflict over its lung disease treatment Yutrepia, ending six lawsuits involving patent infringement, trade secrets, contractual disputes and antitrust allegations.
The settlement, announced Tuesday, allows Liquidia to continue selling Yutrepia for pulmonary arterial hypertension, or PAH, while requiring the company to stop promoting and commercializing the treatment for pulmonary hypertension associated with interstitial lung disease, known as PH-ILD, according to Reuters and company disclosures.
The agreement marks the conclusion of a prolonged dispute between two competing developers of treprostinil-based treatments. Liquidia’s Yutrepia is a dry-powder inhaled formulation of the drug, while United Therapeutics markets the competing Tyvaso franchise.
Under the financial terms disclosed by Liquidia, the company will make an initial net payment of $175 million to United Therapeutics within 30 business days. Two additional installments of $72.7 million each are scheduled for January 31 and April 30, 2027.
Liquidia will separately pay $60.3 million in October to parties holding interests in related antitrust litigation involving Treprostinil Injection. Together, the payments represent the approximately $380.7 million settlement cost.
Deal Follows Delaware Patent Ruling
The settlement comes two weeks after a federal court in Delaware ruled against Liquidia in a patent dispute concerning Yutrepia’s use for PH-ILD.
On September 30, the court found that two claims of United Therapeutics’ U.S. Patent No. 11,826,327 were valid and infringed by Liquidia. The patent covers methods of treating PH-ILD with inhaled treprostinil, including dry-powder formulations.
As part of the settlement, Liquidia agreed not to appeal the decision and submitted a request to the U.S. Food and Drug Administration to remove the PH-ILD indication from Yutrepia’s approved labeling.
The company also agreed to discontinue clinical trial cohorts investigating Yutrepia for PH-ILD and stop publication of related study data, according to a United Therapeutics regulatory filing cited by Reuters.
The settlement includes mutual legal releases and does not constitute an admission of liability by either company. Following the initial payment, the companies are expected to file documents formally dismissing the pending litigation with prejudice, preventing those claims from being brought again between the parties.
The six proceedings span patent infringement allegations, claims involving the alleged misuse of trade secrets, contractual disputes and antitrust litigation concerning treprostinil products.
Yutrepia Retains Access to Key Treatment Market
The commercial provisions are central to the agreement because they preserve Liquidia’s ability to compete in PAH, even as the company relinquishes its position in PH-ILD.
PAH is a progressive disorder involving elevated blood pressure in the pulmonary arteries. PH-ILD, by contrast, develops in association with lung diseases that cause inflammation and scarring.
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Both conditions can be treated with inhaled treprostinil, making the two indications important to the commercial strategies of Liquidia and United Therapeutics.
Yutrepia will remain available for PAH patients without interruption, Liquidia said. The company will also continue developing its broader clinical portfolio, including L606, an experimental extended-release treprostinil treatment being studied for PAH and PH-ILD.
For United Therapeutics, the restrictions on Yutrepia reduce competition for Tyvaso in the PH-ILD market. Jefferies analyst Roger Song said the agreement could improve visibility into the future growth of the Tyvaso franchise, according to Reuters.
Liquidia Plans to Fund Payments Through Existing Operations
Liquidia said it expects to finance the settlement through existing cash holdings and ongoing Yutrepia sales rather than seek additional capital.
The company reported preliminary, unaudited Yutrepia net product sales of $222.7 million for the third quarter of 2026 and cash and cash equivalents of $396.1 million as of September 30.
Chief Operating Officer and Chief Financial Officer Michael Kaseta said the company expects to meet its settlement obligations while continuing to invest in its commercial operations and clinical programs.
Liquidia also terminated a promotional agreement involving Treprostinil Injection and will cease commercial support for that product as part of the broader resolution of the antitrust-related matters.
The agreement drew a positive response from analysts, who viewed the removal of legal uncertainty as significant for Liquidia’s commercial outlook. JPMorgan analyst Jessica Fye said the financial payment was more favorable to United Therapeutics than expected, according to Reuters.
Liquidia shares rose nearly 37% in premarket trading Wednesday after losing more than half their value following the September court decision.
Source: Reuters