India Pharma Outlook Team | Thursday, 20 August 2026
The latest USFDA approval has given Glenmark Pharmaceuticals another entry into the US respiratory market with its Fluticasone Propionate Nasal spray.
The company received the final approval on August 20, 2026, for a generic product equivalent to Haleon’s Flonase nasal spray.
The product will add to Glenmark’s respiratory portfolio in the United States. This approval gives the company access to a market that recorded about USD 295.2 million in annual sales for the 12 months, according to IQVIA data. Glenmark Pharmaceuticals will distribute the product across the US market.
Glenmark’s latest USFDA approval covers Fluticasone Propionate Nasal Spray USP at 0.05 mg/spray. The FDA has determined the product to be bioequivalent and therapeutically equivalent to Flonase nasal spray, 0.05 mg/spray, from Haleon US Holdings LLC.
Glenmark Pharmaceuticals will distribute the approved nasal spray in the United States. The product adds another respiratory treatment to Glenmark’s US portfolio. The company has continued to expand its respiratory presence in the US.
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.”
Earlier in March 2026, Glenmark secured FDA approval for Fluticasone Propionate Inhalation Aerosol, 44 mcg per actuation. That product received Competitive Generic Therapy designation and first-approved-applicant status.
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The latest USFDA approval gives Glenmark an opportunity in a sizeable nasal spray market. IQVIA data shows that the Flonase nasal spray market recorded approximately USD 295.2 million in annual sales during the 12 months ending June 2026.
The approval also comes as Glenmark expands its US business. The company’s US business grew 19.8 per cent year-on-year in Q1 FY27, excluding out-licensing income, according to recent market data. New product launches supported the growth.
Glenmark can now use its latest product approval to deepen its presence in the US generic respiratory segment. The company’s existing respiratory focus gives the new nasal spray a broader portfolio context.
The new USFDA approval fits Glenmark’s wider strategy of expanding respiratory products in the US. The company already markets respiratory therapies and continues to develop additional products for the segment.
Glenmark received 180-day CGT exclusivity eligibility for that product after gaining first-approved-applicant status. The company said the approval strengthened its US respiratory portfolio and supported access to affordable inhalation therapies.
The latest nasal spray approval adds another product to that platform. It also gives Glenmark exposure to a well-established US product category. With its US business showing growth and its respiratory pipeline expanding, Glenmark continues to build its position in the American generic drug market.
