Mumbai, Baltimore: Pharma major Lupin Limited (Lupin) announced that it has received approval for its Divalproex Sodium Extended-Release (ER) Tablets USP,250 mg and 500 mg, from the United States Food and Drug Administration (U.S. FDA), to market a generic equivalent of Depakote®Extended-Release Tablets, 250 mg and 500 mg, of AbbVie Inc.
Lupin’s Divalproex Sodium ER Tablets USP, 250 mg and 500 mgare 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, 250 mg and 500 mg(RLD: Depakote® ER)had annualsales ofapproximatelyUSD159million in the U.S. (IQVIA MATJune2019).
About Lupin Limited
Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.
Lupin is the 8thlargest generics pharmaceutical company by revenues (31stMar 2019, Bloomberg LTM) respectively. The Company is the 3rdlargest pharmaceutical player in the US by prescriptions (IQVIA MAT Jun 2019); 3rdlargest Indian pharmaceutical company by global revenues (31stMar 2019, Bloomberg LTM); 5thlargest generic pharmaceutical player in Japan and 6thlargest company in the Indian Pharmaceutical Market (IQVIA MAT Jun 2019).
For the financial year ended 31stMarch 2019, Lupin’s Consolidated sales and Net profits were at Rs. 163,694 million (USD 2.34 billion) and Rs. 9,466 million (USD 136 million) respectively. Please visit https://www.lupin.com for more information. You could also follow us on Twitter – www.twitter.com/lupinglobal/
CIN: L24100MH1983PLC029442 Registered Office: Lupin Ltd, 3rd Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz (East), Mumbai 400 055.
For further information or queries please contact –
Head – Investor Relations and M&A/ Corporate Communications
Depakote® is a registered trademark of Sanofi.