Lupin Launches Divalproex Sodium ER Tablets USP

Mumbai, Baltimore, September 22, 2020: Pharma major Lupin Limited (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 (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® Extended-Release (ER) Tablets, 250 mg and 500 mg, of AbbVie Inc., 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 USD 130 million in the U.S. (IQVIA MAT July 2020).

About Lupin

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, 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 Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.

The Company enjoys leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women’s health areas. Lupin is the 3^rd largest pharmaceutical company in the U.S. by prescriptions and 5^th in India by global revenues. The Company invests 9.6 % of its revenues on research and development.

Lupin has fifteen manufacturing sites, seven research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.

Please visit www.lupin.com for more information.

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*Safe Harbor Statement

Depakote® ER is the registered trademark of Sanofi