Glenmark Receives US FDA Approval for Generic Version of Flovent

Glenmark Receives USFDA Approval for Fluticasone Propionate Inhalation Aerosol

Glenmark Specialty SA, a subsidiary of Glenmark Pharmaceuticals, 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.

This 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.

Key Highlights:

Read also: Oshea Herbals Aims for Rs 650 Crore Revenue Amidst Expansion Efforts

• Fluticasone Propionate Inhalation Aerosol is expected to launch in the US market in March 2026 through Glenmark Pharmaceuticals Inc., USA.
• The product is expected to capitalize on a market where branded and generic versions of the reference drug generated approximately $520.1 million in sales in the 12 months ending January 2026, according to IQVIA data.
• The approval reinforces Glenmark's capabilities in complex inhalation therapies and adds to its global respiratory portfolio, one of its core therapeutic focus areas alongside dermatology and oncology.

The CGT designation and first-approved applicant status reflect the technical expertise and dedication of Glenmark's teams in bringing complex inhalation therapies to market. The company remains committed to improving access to quality and affordable respiratory treatments for patients and healthcare providers.