Dec 18 2009
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.
http://www.sepracor.com/