Liquidia has filed a lawsuit against the FDA over its decision to grant three years of exclusivity to United Therapeutics’ drug Tyvaso, which competes against Liquidia’s Yutrepia, the company announced Thursday.
Liquidia faced a setback earlier this week when it scored a tentative approval for its treprostinil inhalation powder Yutrepia from the FDA, but was simultaneously delayed from launching until after Tyvaso’s regulatory exclusivity expires on May 23, 2025. Liquidia shares $LQDA are down about 30% over the last week.
The FDA granted tentative approval of Yutrepia to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), the same indications as Tyvaso.
“The FDA’s action improperly allows United Therapeutics to tack on yet another regulatory exclusivity, stifling competition and patient choice,” Liquidia CEO Roger Jeffs wrote in a statement. “This decision violates clear congressional intent to allow [new clinical investigation] exclusivity only for true innovations that are supported by new clinical studies that demonstrate safety and/or efficacy of the innovation.”
Jeffs added that the company believes the FDA’s decision on Tyvaso’s exclusivity should be ended and Yutrepia should be able to enter the market.
In the complaint filed in the District of Columbia, Liquidia alleges that the FDA has “improperly” allowed United to “maintain its decades-long monopoly in violation of clear congressional intent permitting exclusivity only in strictly limited circumstances involving innovation.” Liquidia is asking for the court to declare that the FDA’s decision to grant Tyvaso exclusivity and not give Yutrepia full approval exceeds the agency’s authority.
Liquidia also pointed out in its Thursday announcement that United Therapeutics had voluntarily dismissed without prejudice the complaint it had filed earlier this year against the FDA over how the agency handled Liquidia’s new drug application for Yutrepia.
United Therapeutics filed the lawsuit in the US District Court for the District of Columbia in February, alleging that Liquidia used United’s research to support a second indication in PH-ILD. The FDA tentatively approved Yutrepia to treat PAH in 2021, and then last year, Liquidia amended its NDA to add the indication to treat PH-ILD too. According to court filings, United Therapeutics dismissed its suit on Aug. 20, the day after Liquidia announced it had received tentative FDA approval.