Glenmark Secures US Approval for Fluticasone Inhaler, Awarded 180-Day Exclusivity

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Glenmark Wins US FDA Nod for Fluticasone Inhaler, Gets 180-Day Exclusivity

Glenmark Wins US FDA Nod for Fluticasone Inhaler, Gets 180-Day Exclusivity

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CNBC TV18•04-03-2026, 14:58

Glenmark Wins US FDA Nod for Fluticasone Inhaler, Gets 180-Day Exclusivity

•Glenmark Specialty SA received final US FDA approval for Fluticasone Propionate Inhalation Aerosol, adding to its US respiratory portfolio.
•The product is deemed bioequivalent and therapeutically equivalent to FloVent HFA Inhalation Aerosol, 44 mcg.
•Glenmark secured Competitive Generic Therapy (CGT) designation, making it the 'first approved applicant' eligible for 180 days of exclusivity.
•Distribution by Glenmark Pharmaceuticals Inc., USA is set to begin in March 2026.
•The FloVent HFA 44 mcg market recorded annual sales of approximately $520.1 million, according to IQVIA data.

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