Actavis confirms Vimpat patent challenge and gets OK for generic Opana

US generics major Actavis (NYSE: ACT) confirmed on Friday (July 12) that it has filed an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval to market lacosamide tablets. 50mg, 100mg, 150mg and 200mg, a generic version of Belgian drugmaker UCB’s (Euronext Brussels: UCB) Vimpat, 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 and Harris FRC Corp filed suit against Actavis on July 10, 2013 in the US District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of US Patent No RE 38,551. The law suit 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 around $338 million according to IMS Health data quoted by Actavis.