New York, NY, United States (4E) – Ireland-based Actavis plc said on Friday that it has filed with the U.S. Food and Drug Administration (USFDA) an Abbreviated New Drug Application (ANDA), seeking approval to sell Rotigotine extended-release transdermal film.
The product is a generic version of Neupro — a drug used to treat signs and symptoms of idiopathic Parkinson’s disease as well as Restless Legs Syndrome – that is manufactured by UCB, Inc.
Earlier this week, UCB has filed a lawsuit against Actavis’ subsidiaries in the U.S. District Court for the District of Delaware, which aims to stop Actavis from commercializing its ANDA product before certain U.S. Patents are due to expire.
The legal action cited the Hatch-Waxman Act, resulting to a hold of the final FDA approval of Actavis’ ANDA product for possibly another 30 months from the date that Actavis’ ANDA filing was received by the plaintiffs or until the court decides on a final resolution, whichever occurs first, subject to any other exclusivities.