Glenmark's ANDAs for epilepsy drug in US face legal challenge

If successful in its challenge of the patent, Glenmark will garner 180 days of exclusivity for its products

Glenmark Pharmaceuticals today said its applications for generic version of epilepsy treatment drug Vimpat in America have been challenged by UCB Inc and other companies in a US court.

"UCB Inc, UCS Pharma GmbH, Research Corporation Technologies Inc and Harris FRC Corporation filed suit against Glenmark Generics Ltd and Glenmark Generics Inc on July 10, 2013 in the US District Court of Delaware seeking to prevent Glenmark from commercialising its ANDAs prior to expiration of the US Patent No RE 38,551," Glenmark said in a filing to BSE.

The company's subsidiary Glenmark Generics had filed the abbreviated new drug applications (ANDAs) for Lacosamide tablets and oral solution with US Food and Drug Administration (USFDA) with a Paragraph IV certification, Glenmark said.

"If Glenmark is successful in its challenge of the patent, it will garner 180 days exclusivity for its products," it added.

According to IMS Health data for the 12 months ending March 31, 2013 Vimpat tablets and solution had total US sales of approximately $353 million, Glenamrk said.

Vimpat is indicated for an adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy.

The company scrip closed at Rs 597.70 on the BSE, down 1.14% from its previous close.