Glenmark wins US nod for Fluticasone inhaler, to get 180-day exclusivity
Published on 04/03/2026 02:58 PM
Glenmark wins US nod for Fluticasone inhaler, to get 180-day exclusivityGlenmark Specialty SA has received US FDA approval for its Fluticasone Propionate inhalation aerosol, securing 180-day competitive generic therapy exclusivity in a market with annual sales of over $520 million.By Sheersh Kapoor March 4, 2026, 2:58:13 PM IST (Published)1 Min ReadGlenmark Pharmaceuticals arm, Glenmark Specialty SA has received final approval from the US Food & Drug Administration (FDA) for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation, marking a fresh addition to its US respiratory portfolio.
The product has been deemed bioequivalent and therapeutically equivalent to the reference listed drug, FloVent HFA Inhalation Aerosol, 44 mcg.
Glenmark has also secured Competitive Generic Therapy (CGT) designation and is recognised as the “first approved applicant”, making it eligible for 180 days of CGT exclusivity upon commercial launch.
The company said the product will be distributed in the United States by Glenmark Pharmaceuticals Inc., USA starting March 2026.
According to IQVIA data for the 12 months ended January 2026, the FloVent HFA 44 mcg market recorded annual sales of approximately $520.1 million, including brand and therapeutic equivalents.
The approval comes as Glenmark continues to expand its presence in complex inhalation therapies in the US, one of its key overseas markets.
As of 2:39 pm on March 4, shares of Glenmark Pharmaceuticals Ltd were trading at ₹2,051.40, down ₹71.90 or 3.39% on the NSE.
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