Last updated on April 18, 2014 at 7:47 EDT

Lupin Receives FDA Approval to Market Generic Lutera® Tablets

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(R) 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(R) 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


Safe Harbor Statement [http://www.lupinworld.com/safe%20harbor ]

Lutera(R) 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

Source: PR Newswire