Last updated on April 23, 2014 at 11:18 EDT

Lupin Receives FDA Approval for its Oral Contraceptive Kurvelo® Tablets; The Generic of Nordette® Tablets

October 18, 2012

MUMBAI, India and BALTIMORE, Maryland, October 18, 2012 /PRNewswire/ –


Pharma major, Lupin Ltd., announced today that its subsidiary Lupin Pharmaceuticals
Inc. (collectively Lupin) has received final approval for its oral contraceptive
Kurvelo(R) Tablets (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) Nordette(R) Tablets (Levonorgestrel and Ethinyl
Estradiol Tablets, USP), 0.15 mg/0.03 mg.

Lupin’s Kurvelo(R) Tablets are the AB-rated generic equivalent of Teva’s Nordette(R)
Tablets. Lupin’s Kurvelo(R) tablets is a Levonorgestrel and Ethinyl estradiol combined
oral contraceptive indicated for the prevention of pregnancy in women who elect to use
this product as a method of contraception. Lupin is marketing its Kurvelo(R) tablets in 21
light orange colored active tablets containing 0.15 mg Levonorgestrel and 0.03 mg Ethinyl
estradiol and seven pink inert tablets (without hormones). This dosage regimen is
identical to that of Nordette(R).

Nordette(R) Tablets had annual U.S sales of approximately USD 59 million (IMS MAT Jun
2012 sales).

The OC market in the U.S is valued at close to USD 5.0 Bn. It’s a very niche segment
and requires a high level of R&D expertise, API strengths and manufacturing competencies
and as such, is a much less competed for space. The 5th largest Generic player by
prescription, Lupin is the most vertically integrated generic OC player for the US market
and has a dedicated OC facility in Indore. Lupin’s current ANDA filings for OC’s stand at
30, which is the largest product pipeline for the US Generic OC market.

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 .

For further information or queries please contact -

        Shamsher Gorawara
        Head - Corporate Communications
        Lupin Limited:
        Ph: +91-98-20-338-555
        Email: shamshergorawara@lupinpharma.com

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

Kurvelo(R) is a registered trademark of Lupin.

SOURCE Lupin Ltd

Source: PR Newswire