London: Liquidia Corp has filed a legal challenge to the U.S. Food and Drug Administration’s decision to grant three-year exclusivity to United Therapeutics’ inhaled drug used to treat lung disorders, it said on Thursday.
The FDA on Monday granted regulatory exclusivity to United’s Tyvaso DPI, which delays traditional approval for Liquidia’s inhaled drug, yutrepia.
Tyvaso DPI and yutrepia are inhaled drugs used to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
Liquidia filed the litigation in the district court of the District of Columbia.
(Reporting by Sneha S K; Editing by Mrigank Dhaniwala)