Product Details
Glenmark Pharmaceuticals Inc., USA launched Lacosamide Injection USP, 200 mg/20 mL (10 mg/mL), Single-Dose Vials on June 5, 2026. The product is bioequivalent and therapeutically equivalent to the reference listed drug, Vimpat® Injection, 200 mg/20 mL (10 mg/mL), of UCB, Inc. [NDA 022254].
Market Context
According to IQVIA® sales data for the 12-month period ending April 2026, the Vimpat® Injection market achieved annual sales of approximately $15.2 million. The market data includes both brand and all available therapeutic equivalents.
Regulatory Notes
The product is only approved for the indication(s) listed in Glenmark's approved label and is not marketed for all reference listed drug (RLD) indications. All brand names and trademarks mentioned are the property of their respective owners.
Management Commentary
Marc Kikuchi, President & Business Head, North America, stated: "The launch of Lacosamide Injection USP reflects the disciplined execution of our strategy to build a broader, differentiated product portfolio in the United States. By expanding our injectable product portfolio, we are enhancing our ability to meet the evolving needs of healthcare providers while advancing our commitment to improving patient access to quality, affordable treatment options."
Company Background
Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK) is a global, research-led pharmaceutical company with 11 manufacturing facilities across four continents, six R&D centres, and commercial presence in 80+ countries. The company focuses on respiratory, dermatology, and oncology therapeutic areas.
Financial Impact
Financial impact not quantified in the disclosure beyond the reference market size of $15.2 million annually.