Glenmark Generics Limited confirms that it has filed Abbreviated New Drug Applications (ANDAs) for Lacosamide Tablets, and Oral Solution with the U.S. Food and Drug Administration (FDA) with a Paragraph IV Certification for the Orange-Book listed patent. Glenmarks 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, INC., UCS Pharma GmbH, Research Corporation Technologies, Inc. and Harris FRC Corporation filed suit against Glenmark Generics Limited and Glenmark Generics Inc. on July 10, 2013, in the United States District Court for the District of Delaware, seeking to prevent Glenmark from commercializing its ANDA product prior to the expiration of U.S. 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 31 March 2013, VIMPAT tablets and Solution had total U.S. sales of approximately $353 mn.
See the rest here:
Glenmark Pharma confirms patent challenge for VIPMAT