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Biotech / Medical : Sepracor-Looks very promising
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From: rkrw2/16/2009 4:37:41 PM
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Sepracor's Lunesta targeted by genericsBoston Business Journal - by Craig M. Douglas

Drug maker Sepracor Inc. said two competitors have filed applications to produce and market generic versions of its blockbuster sleep aid Lunesta.

The Marlborough, Mass., company disclosed in a regulatory filing late Friday, Feb. 13, that Teva Pharmaceuticals USA Inc. (Nasdaq: TEVA) and Cobalt Laboratories Inc. each filed so-called abbreviated new drug applications with the U.S. Food and Drug Administration. The applications allege that at least one of Sepracor’s patents for eszopiclone tablets, branded as Lunesta, is “invalid, unenforceable or not infringed by their respective proposed generic products.”

Sepracor (Nasdaq: SEPR) said it expects additional notices of ANDAs filed by other competitors and producers of generic drugs. Lunesta, a sleep aid used to primarily treat insomnia, won FDA approval to sell the drug in the United States in December 2004. Lunesta sales comprised roughly half of Sepracor’s $864.7 million in total product sales during the nine months ended Sept. 30.

The company said it could commence legal action and possibly delay Cobalt and Teva’s ANDA approval until June 2012 or “until a court decides that Sepracor’s patents are invalid, unenforceable or not infringed, whichever is earlier,” according to the regulatory filing
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