Pharma major Lupin Limited announced on Saturday that its U.S subsidiary, Lupin Pharmaceuticals, Inc.

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(LPI) has received tentative approval for the company’s Abbreviated New Drug Application (ANDA) for Eszopiclone tablets, 1 mg, 2 mg and 3 mg from the U.S. Food and Drug Administration (USFDA).

The company said its Eszopiclone tablets are the AB-rated generic equivalent of Sepracor’s LUNESTA® tablets, indicated for the treatment of insomnia. The brand product had annual sales of approximately $761 million for the twelve months ended December 2009, based on IMS Health sales data.

Commenting on the approval, Vinita Gupta, President and CEO of Lupin Pharmaceuticals, Inc. said, “We are pleased to receive this tentative approval and look forward to bringing Eszopiclone tablets to the US market as an affordable generic alternative post patent expiry”.

The product will be introduced in the market through LPI’s strong network of national wholesalers and pharmacy chains post patent expiry in 2012.

Headquartered in Mumbai, India, Lupin Limited is an innovation led transnational pharmaceutical company producing a wide range of quality, affordable generic and branded formulations and APIs for the developed and developing markets of the world. The ompany today has significant market share in key markets in the Cardiovasculars (prils and statins), Diabetology, Asthma, Pediatrics, CNS, GI, Anti-Infectives and NSAIDs therapy segments, not to mention global leadership positions in the Anti-TB and Cephalosporins.

Lupin has the unique distinction of being the fastest growing top 10 Generics players in the two largest pharmaceutical markets of the world – The U.S (ranked 8th by prescriptions & growing at 50 %) and Japan (ranked 7th and growing at 23%). The company is also the fastest growing, top 5 pharmaceutical players in India (ORG IMS - March 2009) and the fastest growing Generic player in South Africa (ranked 6th and growing at 36 % YoY - IMS)

For the financial year ended March 2009, Lupin's consolidated Revenues and Profit after Tax were Rs.39,145 million (US$ 851 million) and Rs. 5015 million (US$ 109 million) respectively.

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