Lupin Receives FDA Approval for its Oral Contraceptive Kurvelo® Tablets; The Generic of Nordette® Tablets
MUMBAI, India and BALTIMORE, Maryland, October 18, 2012 /PRNewswire/ --
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Pharma major, Lupin Ltd., announced today that its subsidiary Lupin Pharmaceuticals Inc. (collectively Lupin) has received final approval for its oral contraceptive Kurvelo® Tablets (Levonorgestrel and Ethinyl Estradiol Tablets, USP) 0.15 mg/0.03 mg from the United States Food and Drugs Administration (FDA) to market a generic version of Teva Branded Pharmaceuticals (Teva) Nordette® Tablets (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg.
Lupin's Kurvelo® Tablets are the AB-rated generic equivalent of Teva's Nordette® Tablets. Lupin's Kurvelo® tablets is a Levonorgestrel and Ethinyl estradiol combined oral contraceptive indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Lupin is marketing its Kurvelo® tablets in 21 light orange colored active tablets containing 0.15 mg Levonorgestrel and 0.03 mg Ethinyl estradiol and seven pink inert tablets (without hormones). This dosage regimen is identical to that of Nordette®.
Nordette® Tablets had annual U.S sales of approximately USD 59 million (IMS MAT Jun 2012 sales).
The OC market in the U.S is valued at close to USD 5.0 Bn. It's a very niche segment and requires a high level of R&D expertise, API strengths and manufacturing competencies and as such, is a much less competed for space. The 5th largest Generic player by prescription, Lupin is the most vertically integrated generic OC player for the US market and has a dedicated OC facility in Indore. Lupin's current ANDA filings for OC's stand at 30, which is the largest product pipeline for the US Generic OC market.
About Lupin Limited
Headquartered in Mumbai, Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded and generic formulations and APIs. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership positions in the Anti-TB and Cephalosporin segment.
Lupin is the 5th largest and fastest growing generics player in the US (5.1% market share by prescriptions, IMS Health) and the 3rd largest Indian pharmaceutical company by sales. The Company is also the fastest growing top 10 generic pharmaceutical players in Japan and South Africa (IMS). For the financial year ended March 2012, Lupin's Consolidated Total Income and Profit after Tax were Rs. 70,972 million (USD 1.49 billion) and Rs. 8,676 million (USD 182 million) respectively. Please visit http://www.lupinworld.com for more information.
Lupin Pharmaceuticals, Inc. is the wholly owned U.S. subsidiary of Lupin Limited. Headquartered in Baltimore, Maryland, Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality, affordable generic medicines and branded formulations trusted by healthcare professionals and patients across geographies. For more information, visit http://www.lupinpharmaceuticals.com .
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Head - Corporate Communications
Kurvelo® is a registered trademark of Lupin.
SOURCE Lupin Ltd