Glenmark Pharmaceuticals on Thursday launched of Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL) Multiple-Dose Vial.
Epinephrine injection is used for emergency treatment of severe allergic reactions (including anaphylaxis) to insect bites or stings, medicines, foods, or other substances. According to Mayo Clinic, it is also used to treat anaphylaxis caused by unknown substances or triggered by exercise.
According to the company’s statement, 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, it added.
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.
“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 in a statement.
