Glenmark Pharmaceuticals Inc., USA (Glenmark) has launched Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL) Multiple-Dose Vial. The product is bioequivalent and therapeutically equivalent to Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL) of BPI Labs, LLC (NDA 205029).
This launch qualifies 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).
According to IQVIA sales data for the 12-month period ending December 2024, the Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL) market recorded annual sales of approximately $42.7 million.
Marc Kikuchi, President & Business Head, North America, Glenmark, said, “We are excited to announce the launch of Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL) Multiple-Dose Vial, growing our portfolio of products within the institutional channel, while also strengthening our commitment to bring to market quality and affordable alternatives for patients.”