The Food and Drug Administration has granted final approval to Teva for its application to market a generic version of Trileptal, by Novartis, for the treatment of epilepsy.
The generic, oxcarbazepine, will be available in 150, 300 and 600 mg tablets. Teva will begin shipping the drug in the near future.
Teva is currently involved in patent litigation concerning this product in the U.S. District Court for the District of New Jersey. A trial date has not been set.
The brand product had annual sales of approximately $690 million in the United States for the twelve months ended Sept. 30, 2007, based on IMS sales data.