Last updated on April 19, 2014 at 17:21 EDT

Lupin Receives FDA Approval for Generic Lexapro® Tablets

September 13, 2012

MUMBAI, India and BALTIMORE, Maryland, September 13, 2012 /PRNewswire/ –

Pharma major, Lupin Ltd., announced today that its subsidiary Lupin Pharmaceuticals
Inc. (collectively, Lupin) has received final approval for its Escitalopram Tablets
(Escitalopram oxalate) 5 mg, 10 mg, and 20 mg, from the United States Food and Drugs
Administration (FDA) to market a generic version of Forest Laboratories, Inc.’s (Forest)
Lexapro Tablets, 5 mg, 10 mg, and 20 mg.

Lupin’s Escitalopram Tablets USP, 5 mg, 10 mg, and 20 mg is the AB-rated generic
equivalent of Forest’s Lexapro(R) Tablets and is indicated for acute and maintenance
treatment of major depressive disorder in adults and adolescents aged 12-17 years. It is
also indicated for the acute treatment of general anxiety disorder in adults.

Lexapro(R) Tablets had annual U.S sales of approximately USD 2.7 billion for the
twelve months ending June, 2012 (IMS Health Sales Data). Lupin remains the 5th largest
generics player in the US (5.5% market share by prescriptions, IMS Health), the only Asian
company to achieve that distinction.

About Lupin Limited

Headquartered in Mumbai, Lupin is an innovation led transnational pharmaceutical
company producing a wide range of generic and branded formulations and APIs. The Company
today has significant presence in the Cardiovascular, Diabetology, Asthma, Paediatrics,
CNS, GI, Anti-Infective and NSAID space in addition to holding global leadership positions
in the Anti-TB and Cephalosporin segments.

Lupin is the 5th largest and fastest growing generics player in the US (5.5 % market
share by prescriptions, IMS Health), the only Asian company to achieve that distinction.
The company is also the fastest growing top 10 pharmaceutical player in India, Japan and
South Africa (IMS).

For the financial year ended March 2012, Lupin’s Consolidated Revenues and Profit
after Tax were Rs.70,829 Million (USD 1.42 Billion) and Rs. 8,676 Million (USD 190
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 harbor ]
*Lexapro(R)is a registered trademark of Forest Laboratories, 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