Soon after the FDA granted temporary approval to Liquidia’s sNDA for Yutrepia treprostinil DPI, the company announced that it has filed a lawsuit challenging the FDA’s grant of 3-year new clinical investigation exclusivity to United Therapeutics’ Tyvaso treprostinil DPI, which is standing in the way of final approval of Yutrepia. Exclusivity for Tyvaso DPI is scheduled to expire on May 23, 2025.
The FDA tentatively approved Yutrepia for the treatment of pulmonary arterial hypertension (PAH) in November 2021, and the new temporary approval for the sNDA added pulmonary hypertension associated with interstitial lung disease (PH-ILD) as an indication.
United Therapeutics previously sued the FDA over the agency’s acceptance of the Yutrepia sNDA; according to Liquidia, that complaint was withdrawn on August 20, 2024. United Therapeutics has also actively pursued litigation alleging that Yutrepia infringes on Tyvaso patents.
Liquidia CEO Roger Jeffs commented, “The FDA’s action improperly allows United Therapeutics to tack on yet another regulatory exclusivity, stifling competition and patient choice. This decision violates clear congressional intent to allow NCI exclusivity only for true innovations that are supported by new clinical studies that demonstrate safety and/or efficacy of the innovation. It is our strong belief that the FDA’s decision to grant Tyvaso DPI this new NCI exclusivity should be vacated, and Liquidia should be allowed to bring Yutrepia to market for the benefit of patients immediately.”
Read the Liquidia press release.
