Lupin Receives FDA Approval to Market Generic Lutera® Tablets

        Lupin Receives FDA Approval to Market Generic Lutera® Tablets

  PR Newswire

  MUMBAI and BALTIMORE, January 22, 2013

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
 
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