Glenmark Pharmaceuticals has announced that its subsidiary Glenmark Specialty SA has received final approval from the U.S. Food and Drug Administration for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation. The medicine is a generic version of Flovent HFA, an inhaled corticosteroid widely used for the maintenance treatment of asthma.
The newly approved inhaler has been found bioequivalent and therapeutically equivalent to the reference drug, meaning it works in the same way and provides the same clinical benefits as the branded product.
With this approval, Glenmark has also received the Competitive Generic Therapy (CGT) designation from the FDA and is recognized as the first approved applicant for this product. This status allows the company to receive 180 days of market exclusivity when the product is launched in the United States.
The inhaler will be distributed in the US by Glenmark’s American subsidiary starting March 2026. The approval is expected to strengthen the company’s respiratory product portfolio in the US market and increase access to affordable asthma treatments.
According to IQVIA market data, the US market for the 44 mcg strength of Flovent HFA recorded annual sales of about $520 million for the 12-month period ending January 2026. This highlights the significant demand for asthma maintenance therapies.
Fluticasone propionate inhalation aerosol is used as a maintenance therapy to control asthma symptoms by reducing inflammation in the lungs. It is prescribed for regular use to prevent symptoms such as wheezing and shortness of breath but is not meant for immediate relief during sudden asthma attacks.
