Glenmark’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 approximately $42.7 million*.
Commenting on the launch, Marc Kikuchi, President & Business Head, North America 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.”
Read also: Glenmark Rolls Out Generic Xalatan in US, Targets USD 113M Market
Glenmark Pharmaceuticals Ltd. is a research-led, global pharmaceutical company, having a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology. The company has 11 world-class manufacturing facilities spread across 4 continents, and operations in over 80 countries. Scrip 100 positions Glenmark amongst the Top 100 biopharmaceutical companies ranked by Pharmaceutical Sales in 2023; while Generics Bulletin places it in the Top 50 Generics and biosimilar companies ranked by sales in 2024. The organization has impacted over 3.3 million lives over the last decade through its CSR interventions.
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