Mumbai, February 27, 2025 – Glenmark Pharmaceuticals Inc., USA, a subsidiary of Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK), has announced the launch of Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL) Multiple-Dose Vial in the United States. The product is bioequivalent and therapeutically equivalent to the reference-listed drug by BPI Labs, LLC (NDA 205029).
Regulatory Advantage: CGT Exclusivity
The launch is eligible for 180 days of Competitive Generic Therapy (CGT) exclusivity under section 505(j)(5)(B)(v) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This exclusivity grants Glenmark a significant market advantage in the initial period following the launch.Market Potential
According to IQVIA™ sales data, the Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL) market generated approximately $42.7 million in annual sales for the 12-month period ending December 2024.Management Commentary
Marc Kikuchi, President & Business Head, North America, Glenmark Pharmaceuticals, stated:Company Overview
Glenmark Pharmaceuticals Ltd. is a research-driven global pharmaceutical company with operations across Branded, Generics, and OTC segments. The company specializes in respiratory, dermatology, and oncology therapeutic areas. With 11 world-class manufacturing facilities across four continents and a presence in over 80 countries, Glenmark ranks among the Top 100 Biopharmaceutical Companies and Top 50 Generics and Biosimilar Companies worldwide.Glenmark is also committed to sustainability, being the second pharmaceutical company in India to receive approval from the Science Based Target Initiative (SBTi) for its greenhouse gas (GHG) emission reduction targets.