Lupin unveils bipolar disorder drug Divalproex Sodium ER Tablets in US

Published On 2020-09-23 06:45 GMT   |   Update On 2020-09-23 06:45 GMT
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Mumbai, Baltimore: Pharma major Lupin Limited has recently 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 (U.S. 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 ExtendedRelease (ER) Tablets, 250 mg and 500 mg, of AbbVie Inc., indicated for:

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• 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 USD 130 million in the U.S. (IQVIA MAT July 2020).
Lupin Limited is a global pharmaceutical company based in Mumbai, Maharashtra, India.

The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.




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