The FDA approval, which is not expected to be final until 2008 when Abbott’s patent expires, is for Divalproex, a sodium delayed-release tablet to be produced in three different strengths.
Upon final approval, Teva’s Divalproex will be the AB-rated generic equivalent of Abbott’s Depakote tablets. This product is indicated for treatment of manic episodes associated with bipolar disorder, prophylaxis of migraine headaches, and as therapy in several types of epileptic disorders.
According to Teva, Depakote produces annual sales of approximately $813 million.