MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sepracor Inc. (Nasdaq: SEPR - News) today announced that it has filed a lawsuit in the U.S. District Court for the District of New Jersey against those companies who have filed abbreviated new drug applications (ANDAs) with Paragraph IV certifications for generic copies of eszopiclone. Sepracor markets eszopiclone in the U.S. under the brand name LUNESTA®. The lawsuit alleges infringement of Sepracor’s U.S. Patent Numbers 6,319,926; 6,444,673; 6,864,257; and 7,381,724.
“Given the success of LUNESTA, we were not surprised by the ANDA filings,” said Adrian Adams, President and Chief Executive Officer of Sepracor. “We believe that our patent position for LUNESTA is strong, and we are prepared to vigorously protect our patent rights.”
Due to the commencement of this litigation, ANDA approval will be stayed until approximately June 15, 2012 (or potentially six months thereafter if Sepracor successfully obtains a pediatric exclusivity extension) or until a court decides that Sepracor’s patents are invalid, unenforceable or not infringed, whichever is earlier. Should Sepracor successfully enforce its patents, ANDA approval should not occur until expiration of the applicable patents, one of which may be extended by Sepracor’s outstanding patent term extension application.
About Sepracor
Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease by discovering, developing and commercializing innovative pharmaceutical products that are directed toward serving large and growing markets and unmet medical needs. Sepracor’s drug development program has yielded a portfolio of pharmaceutical products and candidates with a focus on respiratory and central nervous system disorders. Currently marketed products include LUNESTA® brand eszopiclone, XOPENEX® brand levalbuterol HCl Inhalation Solution, XOPENEX HFA® brand levalbuterol tartrate Inhalation Aerosol, BROVANA® brand arformoterol tartrate Inhalation Solution, OMNARIS™ brand ciclesonide Nasal Spray and ALVESCO® brand ciclesonide HFA Inhalation Aerosol. Sepracor’s corporate headquarters are located in Marlborough, Massachusetts.
Forward-Looking Statement
This news release contains forward-looking statements that involve risks and uncertainties, including statements regarding potential generic competition. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are regulatory, legal and political conditions affecting the pharmaceutical industry and/or the ANDA approval process; the scope of Sepracor’s patents and the patents of others and the success of challenges by others of Sepracor’s patents; and certain other factors that may affect future operating results, which are detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2008 filed with the Securities and Exchange Commission (SEC) and other reports filed with the SEC.
In addition, the statements in this press release represent Sepracor’s expectations and beliefs as of the date of this report. Sepracor anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while Sepracor may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Sepracor’s expectations or beliefs as of any date subsequent to the date of this press release.
LUNESTA, XOPENEX, XOPENEX HFA and BROVANA are registered trademarks of Sepracor Inc. OMNARIS is a trademark and ALVESCO is a registered trademark of Nycomed GmbH.
For a copy of this release or any recent release, visit Sepracor’s web site at www.sepracor.com.
Contact:
Sepracor Inc. Jonaé R. Barnes, 508-481-6700 Sr. Vice President, Investor Relations and Corporate Communications
