Sepracor's LUNESTA receives patent term extension from USPTO

Sepracor Inc. today announced that the United States Patent and Trademark Office has determined that U.S. Patent No. 6,444,673, which is a composition of matter patent that covers the human drug product LUNESTA^® (eszopiclone), received a patent term extension under 35 U.S.C. § 156. The period of extension was determined to be 760 days, and the new expiration date of the patent is February 14, 2014. LUNESTA is marketed by Sepracor for the treatment of insomnia. In addition, the exclusivity period could potentially be extended for an additional six months if Sepracor successfully obtains a pediatric exclusivity extension by submitting data developed in accordance with the pediatric Written Request.

In 2008 and early 2009, Sepracor completed two pediatric studies of LUNESTA in response to a Written Request from the U.S. Food and Drug Administration (FDA) in connection with its efforts to obtain pediatric exclusivity for LUNESTA. In April 2009, Sepracor initiated two additional pediatric studies in accordance with the FDA’s Written Request. In July, the FDA notified Sepracor that it placed these two studies on clinical hold due to its concerns regarding non-clinical data that the FDA thought could be relevant to the administration of eszopiclone in children. The FDA recently informed Sepracor that the clinical hold placed on these LUNESTA pediatric studies has now been lifted. The company is in the process of determining the next steps for the trials.