Lupin launches divalproex sodium ER tablets

Lupin announced the launch of divalproex sodium extended-release (ER) tablets USP, 250 mg and 500 mg, having received an approval from the United States Food and Drug Administration (US FDA) earlier. The product will be manufactured at Lupin’s Nagpur facility in India.

Divalproex sodium ER tablets USP, 250 mg and 500 mg, is the generic equivalent of depakote extended release (ER) tablets, 250 mg and 500 mg, of AbbVie indicated for:

• Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features

• Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures

• Prophylaxis of migraine headaches

Divalproex sodium extended-release (ER) tablets USP (RLD: Depakote ER) had annual sales of approximately $130 million in the US (IQVIA MAT July 2020).