New Launch27 Feb 2025, 02:28 pm
Glenmark Pharmaceuticals Inc., USA Launches Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL) Multiple-Dose Vial with 180 Days of CGT Exclusivity
AI Summary
Glenmark Pharmaceuticals Inc., USA (Glenmark) has announced the launch of Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL) Multiple-Dose Vial. The product 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 is eligible for 180 days of CGT exclusivity under section 505(j)(5)(B)(v) of the FD&C Act. As of December 2024, the Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL) market achieved annual sales of approximately $42.7 million according to IQVIA™ sales data.
Key Highlights
- Glenmark Pharmaceuticals Inc., USA launches Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL) Multiple-Dose Vial.
- The launched product 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 is eligible for 180 days of CGT exclusivity under section 505(j)(5)(B)(v) of the FD&C Act.
- As of December 2024, the Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL) market achieved annual sales of approximately $42.7 million according to IQVIA™ sales data.
- The launch strengthens Glenmark's commitment to bring quality and affordable alternatives for patients.