Glenmark Pharmaceuticals Receives USFDA Approval for Generic Fluticasone Propionate Nasal Spray

Glenmark Pharmaceuticals Ltd announced on Thursday that it has received approval from the United States Food and Drug Administration (USFDA) for its generic version of fluticasone propionate nasal spray, which is used for the treatment of rhinitis.

According to a regulatory filing by the company, the USFDA approval applies to the 0.05 mg/spray strength of fluticasone propionate nasal spray. Glenmark stated that the product is bioequivalent and therapeutically equivalent to the reference listed drug, Flonase nasal spray, 0.05 mg/spray, owned by Haleon US Holdings LLC.

The pharmaceutical company confirmed that the newly approved product will be distributed in the US market directly by Glenmark Pharmaceuticals Inc., USA.

Marc Kikuchi, Glenmark's President and Business Head for North America, commented that the regulatory clearance represents another step forward in expanding the company's respiratory portfolio in the United States. He noted that the development builds upon the established foundation the company has built within this specific therapeutic category.

Citing market data from IQVIA for the 12-month period ending in June 2026, Glenmark highlighted the market potential for the drug. The reference product, Flonase nasal spray, achieved annual sales of approximately $295.2 million in the US during that timeframe.

"Securing regulatory approvals in highly regulated international markets like the United States is a critical milestone for pharmaceutical companies looking to scale their global operations. This USFDA clearance allows Glenmark Pharmaceuticals to tap into a substantial market segment with an established demand profile, as evidenced by the significant annual sales figures of the reference product. Expanding product portfolios in established therapeutic areas helps companies optimize their distribution networks and strengthen their competitive positioning in overseas markets." — Dr. Shishir Gupta, Founder & CEO, StartupLanes