Actavis Files ANDA For Generic Version Of Anticonvulsant Drug Vimpat

(RTTNews) - Specialty pharmaceutical company, Actavis, Inc. (ACT), Friday confirmed that it has filed an Abbreviated New Drug Application or ANDA with the US Food and Drug Administration or FDA seeking approval to market Lacosamide Tablets, 50 mg, 100 mg, 150 mg and 200 mg. Lacosamide is a generic version of UCB Inc.'s Vimpat, which is an anticonvulsant drug approved to treat partial-onset seizures of people diagnosed with epilepsy aged 17 years and older.

In a related development, UCB, Inc., UCB Pharma GMBH, Research Corporation Technologies, Inc. and Harris FRC Corporation filed suit against Actavis on July 10 in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of the patent. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA until April 28, 2016 or final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.

Actavis said it believes to be the first applicant to file an ANDA for the generic version of Vimpat and, should its ANDA be approved, it may be entitled to 180 days of generic market exclusivity. For the 12 months ending February Vimpat had total U.S. sales of about $338 million according to IMS Health data.