Glenmark Launches Generic Epinephrine Injection with 180-Day Exclusivity
Key Insights
Glenmark Pharmaceuticals has launched a generic version of Epinephrine Injection USP (10 mg/10 mL) Multiple-Dose Vial, securing 180 days of competitive generic therapy exclusivity.
The product is bioequivalent to BPI Labs (search)' reference drug and enters a market with annual sales of approximately $42.7 million as of December 2024.
This strategic launch expands Glenmark's institutional channel portfolio, reinforcing their commitment to providing affordable treatment alternatives.
Glenmark Pharmaceuticals Inc., USA has announced the introduction of its generic Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL) Multiple-Dose Vial to the U.S. market. The company has secured 180 days of competitive generic therapy (CGT) exclusivity under the Federal Food, Drug, and Cosmetic Act, positioning itself as the sole generic competitor in this market segment.
Market Impact and Commercial Significance
The launch targets a significant market opportunity, with IQVIA™ data showing annual sales of approximately $42.7 million for the 12-month period ending December 2024. The product is therapeutically equivalent to BPI Labs (search), LLC's reference listed drug (NDA 205029), ensuring identical clinical efficacy and safety profiles.
Marc Kikuchi, President & Business Head, North America at Glenmark, emphasized the strategic importance of this launch: "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."
Company Background and Capabilities
Glenmark Pharmaceuticals maintains a strong global presence in the pharmaceutical industry, operating across Branded, Generics, and OTC segments. The company's expertise spans multiple therapeutic areas, including respiratory, dermatology, and oncology. With 11 manufacturing facilities across four continents and operations in over 80 countries, Glenmark has established itself as a significant player in the global pharmaceutical market.
The company's market position is reflected in its rankings, placing among the Top 100 biopharmaceutical companies by pharmaceutical sales in 2023 according to Scrip 100, and among the Top 50 Generics and biosimilar companies by sales in 2024 as reported by Generics Bulletin.
Environmental and Social Commitment
Beyond its commercial operations, Glenmark has demonstrated commitment to sustainability and social responsibility. In 2023, the company achieved approval from the Science Based Target initiative (SBTi) for its Green House Gas emission reduction targets, becoming only the second pharmaceutical company in India to reach this milestone. The organization has also made significant social impact, touching over 3.3 million lives through various CSR initiatives over the past decade.