Glenmark Receives US FDA Approval for Fluticasone Propionate Nasal Spray
核心洞察
Glenmark Pharmaceuticals received U.S. FDA approval for Fluticasone Propionate Nasal Spray USP, 0.05 mg/spray (50 mcg/spray), expanding its respiratory portfolio in the U.S. market.
The product is bioequivalent and therapeutically equivalent to Flonase Nasal Spray (搜索), the reference listed drug marketed by Haleon US Holdings LLC.
According to IQVIA data for the 12 months ended June 2026, the Flonase Nasal Spray (搜索) market recorded approximately US$295.2 million in annual sales.
Glenmark Pharmaceuticals Limited has received U.S. Food and Drug Administration (FDA) approval for its Fluticasone Propionate Nasal Spray USP, 0.05 mg/spray (50 mcg/spray), a milestone that expands the company's respiratory portfolio in the U.S. market. The approval positions fluticasone as one of Glenmark's key sales drivers in the United States.
The product is bioequivalent and therapeutically equivalent to Flonase Nasal Spray (搜索), the reference listed drug marketed by Haleon US Holdings LLC. Glenmark Pharmaceuticals Inc., USA will distribute the product in the United States.
Market Opportunity
According to IQVIA data for the 12 months ended June 2026, the Flonase Nasal Spray (搜索) market recorded approximately US$295.2 million in annual sales, highlighting the commercial opportunity for the product. Glenmark has positioned fluticasone as one of its key sales drivers in the U.S. market, and this approval follows the marketing nod for the OTC version of the drug in March this year.
Executive Commentary
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.
Competitive Landscape
Other peers, such as Lupin, are also expected to enter the market in the coming months. 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.
Market Response
Glenmark shares climbed more than 3 per cent to Rs 2,317 apiece on the NSE following the announcement.