Actavis, Inc. has confirmed the filing of its Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for seeking approval to market Lacosamide tablets 50 mg, 100 mg, 150 mg and 200 mg. Actavis' ANDA product 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.
UCB, Inc., UCB Pharma GMBH, Research Corporation Technologies, Inc. and Harris FRC Corporation filed suit against Actavis on July 10 in the US District Court for the District of Delaware seeking to prevent Actavis from commercialising its ANDA product prior to the expiration of US Patent No. RE 38,551. 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.
Based on available information, Actavis believes it may be a "first applicant" to file an ANDA for the generic version of Vimpat and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
For the 12 months ending February, 2013, Vimpat had total US sales of approximately $338 million according to IMS Health data.
Actavis, Inc. is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products.