Glenmark Pharmaceuticals Inc., USA, has announced the launch of Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL) Multiple-Dose Vial, an FDA-approved bioequivalent and therapeutically equivalent alternative to the reference drug from BPI Labs, LLC (NDA 205029).
This launch is significant as it qualifies for 180-day Competitive Generic Therapy (CGT) exclusivity under section 505(j)(5)(B)(v) of the FD&C Act. Epinephrine Injection is widely used in emergency medical settings to treat severe allergic reactions, cardiac arrest, and other critical conditions.
According to IQVIA™ sales data for the 12-month period ending December 2024, the Epinephrine Injection USP market reached approximately $42.7 million in annual sales. Glenmark’s introduction of this product strengthens its commitment to providing high-quality, cost-effective medications for patients and healthcare providers.
Marc Kikuchi, President & Business Head, North America, commented, “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.”
