A suit had been filed against Glenmark Generics, a subsidiary of Glenmark Pharmaceuticals in the United States District Court by UCB INC., UCS Pharma GmbH, Research Corporation Technologies Inc. and Harris FRC Corporation, seeking to prevent Glenmark from commercializing its ANDA product prior to the expiration of US Patent. If Glenmark is successful in its challenge of the patent, it will garner 180-day exclusivity for its products.
Glenmark Generics had filed Abbreviated New Drug Applications (ANDAs) for Lacosamide Tablets, and Oral Solution with the US Food and Drug Administration (USFDA) with a Paragraph IV Certification for the Orange-Book listed patent. Glenmark’s ANDA products are generic versions of VIPMAT.
According to IMS health data for the twelve months ending March 31, 2013, VIPMAT tablets and Solution had total US sales of approximately $353 million.
