Glenmark Pharmaceuticals Receives U.S. FDA Approval for Fluticasone Propionate Inhalation Aerosol with 180-Day Exclusivity

Glenmark Pharmaceuticals Ltd's subsidiary, Glenmark Specialty SA, has received final approval from the U.S. FDA for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation, which is bioequivalent and therapeutically equivalent to the reference listed drug, FloVent®2 HFA Inhalation Aerosol, 44 mcg. Glenmark has been granted a Competitive Generic Therapy (CGT) designation and is eligible for 180 days of CGT exclusivity upon commercialization. The product will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA starting in March 2026, strengthening Glenmark’s respiratory portfolio and expanding access to quality inhalation therapies. The FloVent® HFA Inhalation Aerosol, 44 mcg market achieved annual sales of approximately $520.1 million as of January 2026.