Glenmark Secures FDA Approval For Generic Fluticasone Propionate Inhaler With 180-Day CGT Exclusivity

Glenmark Speciality SA has received final approval from the U.S. Food and Drug Administration for its Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation, a generic version of the asthma and respiratory therapy inhaler. The product has been confirmed by the FDA as both bioequivalent and therapeutically equivalent to the reference listed drug, Flovent HFA, developed by GlaxoSmithKline.

The approval comes with a Competitive Generic Therapy (CGT) designation, and Glenmark has been recognized as the “first approved applicant” under the relevant provisions of the FD&C Act. As a result, the company will receive 180 days of CGT exclusivity upon commercial launch in the United States.

The inhalation aerosol will be marketed in the U.S. through Glenmark Pharmaceuticals Inc., the company’s American subsidiary. Commercial distribution is expected to begin in March 2026, strengthening Glenmark’s presence in the respiratory therapeutics segment.

Commenting on the launch, Marc Kikuchi, President & Business Head, North America, said, “Receiving approval for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation marks an important milestone in strengthening our respiratory portfolio in the U.S. The CGT designation and first approved applicant status reflect the technical expertise and dedication of our teams in bringing complex inhalation therapies to market. We remain committed to improving access to quality and affordable respiratory treatments for patients and healthcare providers.”

This regulatory milestone further expands Glenmark’s respiratory portfolio in the U.S. market and reflects the company’s broader strategy to increase access to affordable inhalation therapies for patients with respiratory conditions.

According to IQVIA data, the U.S. market for the 44 mcg strength of Flovent HFA generated approximately $520.1 million in annual sales during the 12-month period ending January 2026, indicating significant market potential for the newly approved generic product.