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PARSIPPANY, N.J. — Actavis is looking to become the first to market a generic drug for epilepsy, the company said Friday.
Actavis announced that it had filed with the Food and Drug Administration for lacosamide tablets in the 50-mg, 100-mg, 150-mg and 200-mg strengths. The drug is a generic version of UBC's Vimpat and is used to treat partial-onset seizures in epilepsy patients aged 17 and older.
Actavis said it intends to challenge the drug's patent protection, and in response to the filing, UCB and several other companies filed a patent-infringement suit against Actavis in the U.S. District Court for the District of Delaware. The lawsuit places a stay of final FDA approval on the drug for 30 months or until the companies settle the case. UCB hopes to prevent Actavis from launching the drug prior to the expiration of a patent that is set to expire in 2022.
Assuming Actavis is the first to file for approval of a generic version of the drug, it expects to receive 180 days of market exclusivity in which to compete directly with UCB's product when the FDA approves it. Vimpat had sales of about $338 million during the 12-month period that ended in February, according to IMS Health.
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