Glenmark Pharmaceuticals is likely to remain in focus after its subsidiary, Glenmark Specialty SA, received final approval from the United States Food and Drug Administration (US FDA) for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation. The approval includes 180 days of Competitive Generic Therapy (CGT) exclusivity upon commercialisation, according to the company’s press release dated March 4, 2026.
The product has been determined by the US FDA to be bioequivalent and therapeutically equivalent to the reference listed drug Flovent HFA Inhalation Aerosol, 44 mcg developed by GlaxoSmithKline. The CGT designation recognises Glenmark as the first approved applicant under the relevant section of the US Federal Food, Drug and Cosmetic Act, enabling the company to benefit from six months of competitive generic therapy exclusivity in the US market.
Glenmark said the Fluticasone Propionate Inhalation Aerosol will be distributed in the United States by Glenmark Pharmaceuticals Inc., USA starting March 2026. The approval further strengthens the company’s respiratory portfolio in the US and supports its focus on expanding access to inhalation therapies.
According to IQVIA sales data for the 12-month period ending January 2026, the Flovent HFA Inhalation Aerosol 44 mcg market recorded annual sales of approximately $520.1 million.
Commenting on the development, Marc Kikuchi, President & Business Head – North America, said receiving the approval for Fluticasone Propionate Inhalation Aerosol marks an important milestone in strengthening the company’s respiratory portfolio in the US. He added that the CGT designation and first approved applicant status reflect the technical expertise of Glenmark’s teams in bringing complex inhalation therapies to market while improving access to affordable respiratory treatments for patients and healthcare providers.
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