LPI's ANDA for Eszopiclone tablets receives tentative approval from USFDA

Lupin Pharmaceuticals, Inc. (LPI) announced today that it 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).

Lupin's 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.