Glenmark receives U.S. FDA approval for Fluticasone Propionate Nasal Spray 0.05 mg/spray, bioequivalent to Flonase Nasal Spray.
Written By: Samiksha Jadhav, BPharm
Reviewed By: Pharmacally Editorial Team
Glenmark Pharmaceuticals has received U.S. FDA approval for Fluticasone Propionate Nasal Spray USP, 0.05 mg (50 mcg) per spray, adding another respiratory product to its U.S. portfolio. The product is bioequivalent and therapeutically equivalent to Flonase Nasal Spray marketed by Haleon.
FDA Approval Expands Glenmark’s U.S. Respiratory Portfolio
The approval covers Glenmark’s Fluticasone Propionate Nasal Spray USP at a strength of 0.05 mg per spray. The company will distribute the product in the United States through Glenmark Pharmaceuticals Inc., USA.
The regulatory milestone strengthens Glenmark’s position in the U.S. respiratory market, where the company already maintains a portfolio spanning respiratory, dermatology, and oncology products. The company said the new approval supports its broader effort to expand access to quality and affordable treatment options.
Bioequivalence Supports Substitution with the Reference Product
Glenmark reported that its fluticasone propionate nasal spray is both bioequivalent and therapeutically equivalent to Flonase Nasal Spray 0.05 mg per spray. The reference product is listed under NDA 020121 and is associated with Haleon US Holdings LLC.
The source announcement does not provide additional clinical trial data, efficacy endpoints, safety findings, or dosing instructions beyond the approved product strength. It also notes that Glenmark’s product is approved only for the indications specified in its own FDA-approved labeling, which may differ from the indications approved for the reference listed drug.
U.S. Market Opportunity
The approval enters a sizeable established market. According to IQVIA National Sales Perspectives data cited by Glenmark, the Flonase Nasal Spray market generated approximately $295.2 million in annual sales during the 12-month period ending June 2026. The reported market includes the brand and available therapeutic equivalents.
This market data provides commercial context for the approval, although Glenmark did not disclose expected launch timing, pricing, projected sales, or market-share targets in the announcement.
Glenmark’s Next Step in U.S. Respiratory Expansion
Marc Kikuchi, President and Business Head, North America, said the approval represents another step in expanding Glenmark’s respiratory portfolio in the United States. He also highlighted the company’s focus on increasing access to quality and affordable treatment options.
Glenmark has not disclosed further regulatory or commercial milestones for the product. The company’s announcement confirms that the approved nasal spray will be marketed in the U.S. only for the indications included in its FDA-approved label.
The approval therefore gives Glenmark another FDA-approved respiratory product while positioning the company to compete in an established U.S. nasal spray market with substantial annual sales.
Reference
About the Writer
Samiksha Vikram Jadhav (LinkedIn) is a B. Pharm graduate with a strong academic foundation in pharmaceutical sciences, pharmacology, and drug development. She specializes in pharma market research, with a focused interest in mergers and acquisitions, strategic partnerships, and global pharma and biotech deals. Her work centers on analyzing industry transactions, market positioning, and business strategies, translating complex developments into clear, accurate, and insightful scientific and commercial reporting.
