Lupin launches generic Divalproex Sodium tablets for bipolar disorder in US

Drug firm Lupin on Tuesday said it has launched generic Divalproex Sodium extended-release tablets used for treatment of various conditions, including manic episodes associated with bipolar disorder, in the American market.

The company has launched Divalproex Sodium extended-release (ER) tablets USP, in the strengths of 250 mg and 500 mg, having received an approval earlier from the United States Food and Drug Administration (USFDA), Lupin said in a statement.

The product will be manufactured at the company's Nagpur facility, it added.

The company's tablet is generic version of AbbVie Inc's Depakote extended-release tablets in the same strengths, Lupin said.

According to IQVIA MAT July 2020 data, Divalproex Sodium extended-release tablets USP had annual sales of approximately USD 130 million (about Rs 950 crore) in the US, it added.

The tablets are indicated for acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features, and for prophylaxis of migraine headaches, the statement said.

The product is also indicated for 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, it added.

Shares of Lupin Ltd on Tuesday closed 0.07 per cent lower at Rs1,040per scrip on the BSE.