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Vanda Patents Found Valid and Infringed in Fanapt® ANDA Litigation

28-Aug-2016 | Source : Vanda Pharmaceuticals | Visits : 6898
WASHINGTON - Vanda Pharmaceuticals Inc. announced in a press release that Judge Gregory M. Sleet of the United States District Court for the District of Delaware ruled thatRoxane Laboratories Inc. (Roxane) infringed US Patent Nos. RE39,198 (the '198 Patent) and 8,586,610 (the '610 Patent) by submitting to the FDA an ANDA seeking permission to market a generic version of Fanapt® before the expiration of Vanda's patents. 

"We are very pleased that the court found both patents valid, found that Roxane's ANDA infringes the '198 patent and the '610 patent, and accordingly issued an injunction barring Roxane from marketing its product until the expiration of the later expiring '610 patent on November 2, 2027," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO.
 
Vanda is a specialty pharmaceutical company focused on the development and commercialization of novel therapies to address high unmet medical needs and improve the lives of patients. 
 
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