By: IPP Bureau
Last updated : February 27, 2025 12:56 pm
This launch of Epinephrine Injection multiple-dose Vial is eligible for 180 days of CGT exclusivity under section 505(j)(5)(B)(v) of the FD&C Act.
Glenmark Pharmaceuticals USA (Glenmark) announces the launch1 of 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 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 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.”