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Last updated on April 16, 2014 at 21:24 EDT

Lupin Launches its Oral Contraceptive Daysee(TM) Tablets in the US Market; Generic of Seasonique® Tablets

April 12, 2013

MUMBAI, India and BALTIMORE, April 12, 2013 /PRNewswire/ –

Pharma major, Lupin Ltd., announced today that its subsidiary Lupin Pharmaceuticals
Inc. (collectively Lupin) has received final approval for its Daysee(TM) Tablets
(Levonorgestrel and Ethinyl Estradiol Tablets, USP, 0.15 mg/0.03 mg and Ethinyl Estradiol
Tablets, USP, 0.01 mg) from the United States Food and Drugs Administration (US FDA) to
market a generic version of Teva Branded Pharm.’s Seasonique Tablets(R). Lupin has already
commenced shipping the product.

Lupin’s Daysee(TM) Tablets is indicated for use by women to prevent pregnancy.

Lupin’s Daysee(TM) Tablet (Levonorgestrel and Ethinyl estradiol tablets USP 0.15
mg/0.03 mg and Ethinyl estradiol tablets USP 0.01 mg) is available in Extended-Cycle
Wallets each containing a 13-week supply of tablets: 84 light blue tablets, each
containing 0.15 mg of Levonorgestrel and 0.03 mg of Ethinyl estradiol, and 7 mustard
tablets, each containing 0.01 mg of Ethinyl estradiol. The light blue tablets are round,
biconvex, film-coated tablets, debossed with “LU” on one side and “V21″ on the other side.
The mustard tablets are round, biconvex, film-coated tablets debossed with “LU” on one
side and “V22″ on the other side.

The total sales for Branded and generic sales for the product stood at USD 161 million
(IMS MAT Dec 2012).

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 [http://www.lupinworld.com/safe harbor ]

        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