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news.Sepracor, a research-based pharmaceutical company, has filed a lawsuit in the US District Court of New Jersey against those companies who have filed abbreviated new drug applications with paragraph IV certifications for generic copies of eszopiclone.
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Sepracor markets eszopiclone in the US under the brand name Lunesta. The lawsuit alleges infringement of Sepracor’s US patents.
Due to the commencement of this litigation, abbreviated new drug application (ANDA) approval will be stayed until approximately June 15, 2012 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.