Unichem Laboratories received final approval for Abbreviated New Drug Application (ANDA) from the US Food and Drug Administration (US FDA) for the Divalproex Sodium delayed release tablets in the multiple strengths of 125 mg, 250 mg, and 500 mg.

It was originally developed and marketed by the Abbott Laboratories under the brand name drug Depakote. It is indicated for the treatment of manic episodes associated with bipolar disorder, migrane head aches and epileptic disorders.

The patent for the product expired in January 2008. So, increased generic competition has resulted in Depakote sales declining from USD 1.3 billion in 2008 to USD 161 million in 2010 in US market. Further, Lupin, Dr. Reddy's Laboratories, Cadila healthcare, Sun Pharma already received the final approval.