Glenmark Pharmaceuticals’ US-based subsidiary -- Glenmark Pharmaceuticals Inc, USA has the launched Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL) Multiple-Dose Vial. The company’s Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL) Multiple-Dose Vial is bioequivalent and therapeutically equivalent to the reference listed drug, Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL), of BPI Labs, LLC, NDA 205029. This launch of Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL) Multiple-Dose Vial is eligible for 180 days of CGT exclusivity under section 505(j)(5)(B)(v) of the 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 achieved annual sales of around $42.7 million.
Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.
