Glenmark Generics has filed Abbreviated New Drug Applications (ANDAs) for Lacosamide tablets, and oral solution with the US Food and Drug Administration (FDA) with a Paragraph IV Certification for the Orange-Book listed patent. Glenmark’s ANDA products are generic versions of VIMPAT, which are indicated for an adjunctive therapy in the treatment for partial-onset seizures in adults with epilepsy.
UCB, UCS Pharma, Research Corporation Technologies and Harris FRC Corporation filed suit against Glenmark Generics and Glenmark Generics on July 10, 2013, in the United States District Court for the District of Delaware, seeking to prevent Glenmark from commercialising its ANDA product prior to the expiration of US Patent No.RE 38,551. This lawsuit was filed under the provisions of the Hatch-Waxman Act. If Glenmark is successful in its challenge of the patent, it will garner 180-day exclusivity for its products.
According to the IMS health data for the twelve months ending March 31, 2013, VIMPAT tablets and Solution had total US sales of approximately $353 million.
EP News Bureau – Mumbai