Glenmark gets USFDA nod for generic Flovent with 180‑day CGT exclusivity

Glenmark Pharma

• Glenmark gets USFDA nod for Fluticasone Propionate inhaler
• Secures 180 days CGT exclusivity as first approved generic
• Glenmark plans US launch in March 2026.

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Glenmark on Wednesday said its subsidiary Glenmark Specialty SA has received final approval from the USFDA for its Fluticasone Propionate Inhalation Aerosol, 44 mcg per actuation, securing 180 days of Competitive Generic Therapy (CGT) exclusivity in the world’s largest pharmaceutical market.

The approval makes Glenmark the first applicant under the CGT pathway for this product, allowing it to launch the inhaler without generic competition for six months once commercialized. The product has been deemed bioequivalent and therapeutically equivalent to GlaxoSmithKline’s FloVent HFA Inhalation Aerosol, 44 mcg, a widely used maintenance treatment for asthma.

Glenmark plans to begin US distribution through Glenmark Pharmaceuticals Inc., USA in March 2026. The move strengthens its respiratory franchise in a market where branded and generic versions of the reference drug generated about $520.1 million in sales in the 12 months ending January 2026, according to IQVIA data.

Marc Kikuchi, President and Business Head for North America, said the approval reinforces Glenmark’s capabilities in complex inhalation therapies.

“Receiving approval for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation marks an important milestone in strengthening our respiratory portfolio in the U.S. The CGT designation and first approved applicant status reflect the technical expertise and dedication of our teams in bringing complex inhalation therapies to market. We remain committed to improving access to quality and affordable respiratory treatments for patients and healthcare providers,” he said.

CGT designations are granted to medicines with limited generic competition, and first‑approved applicants are eligible for six months of exclusivity—an incentive aimed at encouraging development of hard‑to‑copy generics, particularly in categories like inhalation therapies where technical barriers are high.

The approval adds to Glenmark’s global respiratory portfolio, one of its core therapeutic focus areas alongside dermatology and oncology.