By: IPP Bureau
Last updated : August 20, 2026 10:36 am
The company expands its U.S. respiratory portfolio with an FDA-approved generic equivalent to Flonase, targeting a market with annual sales of nearly US$295 million
Glenmark Pharmaceuticals Limited has received U.S. FDA approval for its Fluticasone Propionate Nasal Spray USP, 0.05 mg/spray (50 mcg/spray), expanding the company’s respiratory portfolio in the U.S. market.
The product is bioequivalent and therapeutically equivalent to Flonase Nasal Spray, the reference listed drug marketed by Haleon US Holdings LLC. Glenmark Pharmaceuticals Inc., USA will distribute the product in the United States.
According to IQVIA data for the 12 months ended June 2026, the Flonase Nasal Spray market recorded approximately US$295.2 million in annual sales, highlighting the commercial opportunity for the product.
Marc Kikuchi, President & Business Head, North America said, “The approval of Fluticasone Propionate Nasal Spray USP, 0.05 mg/spray marks another step in expanding our respiratory portfolio in the U.S. and builds on the strong foundation we have established in this therapeutic area.”
“We remain committed to broadening access to quality, affordable treatment options that address the evolving needs of patients and healthcare providers,” he added.
The latest approval further expands Glenmark’s U.S. product portfolio while supporting its strategy of providing quality and affordable treatment options to patients and healthcare providers.