Lupin Receives FDA Approval to Market Generic Lutera® Tablets

MUMBAI and BALTIMORE, January 22, 2013 /PRNewswire/ --

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, 0.1 mg / 0.02 mg from the United States Food and Drugs Administration (US FDA) to market a generic version of Watson Laboratories, Inc.'s Lutera® 28 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 will be marketing its generic product shortly.

Lutera® Tablets had annual U.S sales of approximately USD 103.6 million (IMS MAT Sept 2012 sales).

Lupin entered the US Oral Contraceptives market with the launch of its generic for NOR QD in September 2011 and has the largest OC pipeline for the US market, with 32 filings with the US FDA and has received 7 approvals so far. In December 2012, the company also launched the generic for Yasmin, which has annual sales of approximately USD 275.1 million (IMS MAT Sept 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, visit http://www.lupinpharmaceuticals.com.

Safe Harbor Statement

Lutera® is a registered trademark of Watson Pharmaceutical Inc.

For further information or queries please contact -
Shamsher Gorawara
Head - Corporate Communications
Lupin Limited
Ph: +91-98-20-338-555
Email: shamshergorawara@lupinpharma.com


SOURCE Lupin Ltd




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