Glenmark Pharma's US arm launches Epinephrine Injection USP, 10 mg/10 mL

Glenmark Pharma announced that its US-based subsidiary, Glenmark Pharmaceuticals Inc, has launched the Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL) multiple-dose vial.

Glenmark's Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL) multiple-dose vial is both bioequivalent and therapeutically equivalent to the reference listed drug, Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL), from BPI Labs, LLC, NDA 205029. The launch of this product is eligible for 180 days of CGT exclusivity under Section 505(j)(5)(B)(v) of the Federal Food, Drug, and Cosmetic (FD&C) Act, it added.

Epinephrine injection is used for emergency treatment of severe allergic reactions (including anaphylaxis) to insect bites or stings, medicines, foods, or other substances. It is also used to treat anaphylaxis caused by unknown substances or triggered by exercise.

According to IQVIATM sales data for the 12-month period ending December 2024, the Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL) market2 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.

Glenmark Pharmaceuticals is a global innovation-driven pharmaceutical company with a presence across specialty, generics, and OTC businesses. The company has 11 world-class manufacturing facilities spread across 4 continents and operations in over 80 countries.

On a consolidated basis, the company reported a net profit of Rs 348 crore in Q3 FY25 compared with a net loss of Rs 449.6 crore in Q3 FY24. Revenue from operations surged 35.1% YoY to Rs 3,387.6 crore in the quarter ended 31 December 2024.

Shares of Glenmark Pharmaceuticals shed 0.52% to Rs 1,309.50 on the BSE.

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