Glenmark Pharma launches 10 mg/10 mL Epinephrine Injection USP

A new multiple-dose vial of epinephrine injection USP, 10 mg/10 mL (1 mg/mL), has been introduced by Glenmark Pharmaceuticals Inc., USA (Glenmark).

The reference listed medication, epinephrine injection USP, 10 mg/10 mL (1 mg/mL), of BPI Labs, LLC, NDA 205029, is bioequivalent and therapeutically equivalent to Glenmark's epinephrine injection USP, 10 mg/10 mL (1 mg/mL) multiple-dose vial. According to section 505(j)(5)(B)(v) of the FD&C Act, this introduction of the epinephrine injection USP, 10 mg/10 mL (1 mg/mL) multiple-dose vial is qualified for 180 days of CGT exclusivity.

IQVIA sales data for the 12-month period ending December 2024 shows that the market for epinephrine injection USP, 10 mg/10 mL (1 mg/mL) generated about $42.7 million in sales annually.

 “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”. Marc Kikuchi, president & business head, North America, said while commenting on the launch.

With an emphasis on the therapeutic areas of oncology, dermatology, and respiratory care, Glenmark Pharmaceuticals Ltd. is a multinational pharmaceutical firm that leads research and operates in the branded, generic, and over-the-counter markets. The corporation operates in more than 80 countries and has 11 top-notch manufacturing sites spread across four continents.