Mumbai, Baltimore, October 25, 2012: – Pharma major, Lupin Ltd., announced today that its subsidiary Lupin Pharmaceuticals Inc. (collectively Lupin) has received final approval for its 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) Seasonale® Tablets (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg.
Lupin’s Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg are the AB-rated generic equivalent of Teva’s Seasonale® Tablets. Lupin’s Levonorgestrel and Ethinyl Estradiol tablets are a combined oral contraceptive indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Lupin is marketing its Levonorgestrel and Ethinyl Estradiol tablets in 84 pink active tablets each containing 0.15 mg of Levonorgestrel, a synthetic progestogen and 0.03 mg of Ethinyl estradiol, and 7 white inert tablets. Seasonale® Tablets had annual U.S sales of approximately USD 81.2 million (IMS MAT Jun 2012 sales).
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, visithttp://www.lupinpharmaceuticals.com
For further information please contact:
Shamsher Gorawara
Head – Corporate Communications
Lupin Limited:
Ph: +91 98 20 338 555
Email: shamshergorawara@lupinpharma.com
Or
Rajiv Pillai
Head – Investor Relations
Lupin Limited:
Ph: +91 98 20 552 083
Email: rajivpillai@lupinpharma.com
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