Full Press Release Details
Vanda Patents Found Valid and Infringed in Fanapt ANDA Litigation
WASHINGTON, August 25, 2016 /PRNewswire/ Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that Judge Gregory M. Sleet of the
United States District Court for the District of Delaware ruled that Roxane Laboratories Inc. (Roxane) infringed U.S. 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.
About Vanda Pharmaceuticals Inc.
specialty pharmaceutical company focused on the development and commercialization of novel therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals, please
visit www.vandapharma.com.
Fanapt is a registered trademark of Vanda
Pharmaceuticals Inc.
Senior Vice President and Chief Financial Officer
Vanda Pharmaceuticals Inc.