utah778/iStock via Getty Images Liquidia Corporation ( NASDAQ: LQDA ) announced Thursday a lawsuit challenging the recent FDA decision to grant a three-year exclusivity to Tyvaso DPI from United Therapeutics ( UTHR ), which it said had delayed potential approval for its competing product, Yutrepia. The litigation, filed in a federal court in the District of Columbia, comes days after the FDA granted tentative approval for Yutrepia amid an ongoing patent dispute between Liquidia ( LQDA ) and United ( UTHR ) over the product. The treatment greenlighted for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) is an inhaled dry-powder formulation of treprostinil, the active ingredient of Tyvaso DPI.
At the time of tentative approval, the agency granted a three-year new clinical investigation exclusivity (NCI exclusivity) to Tyvaso DPI, and Liquidia ( LQDA ) said full approval for Yutrepia is expected after the expiry of that exclusivity on May 23, 2025. The company said it is seeking a final approval of Yutrepia “as soon as possible.” “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,” Liquidia ( LQDA ) CEO Roger Jeffs added.
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