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Sepracor's Lunesta patent extended


NEW YORK Sepracor has received a two-year extension on its patent for an insomnia drug, the drug maker announced Friday.

The U.S. Patent and Trademark Office granted a patent term extension to U.S. Patent No. 6,444,673, which covers the drug Lunesta (eszopiclone). The new expiration date for the patent is Feb. 14, 2014.

The company completed two studies of Lunesta in children in 2008 and 2009. The Food and Drug Administration had requested the studies in response to Sepracor’s efforts to win pediatric approval for the drug. The FDA placed a clinical hold on the studies in July due to concerns that some non-clinical data might be relevant to the administration of the drug to children, but it lifted the hold recently, and Sepracor said it was working on determining the next steps of the clinical trials.

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