Actavis plc confirmed it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market Rotigotine Extended-release Transdermal Film, 1 mg/24 hr, 2 mg/24 hr, 3 mg/24 hr, 4 mg/24 hr, 6 mg/24 hr, and 8 mg/24 hr. Actavis’ ANDA product is a generic version of UCB’s Neupro, which is indicated for the treatment of signs and symptoms of idiopathic Parkinson’s disease and moderate-to-severe primary restless legs syndrome (RLS).
UCB Inc, UCB Manufacturing Ireland Limited, UCB Pharma GmbH, and LTS Lohmann Therapie-Systeme AG filed suit against Actavis’ subsidiaries on August 21, 2014 in the US District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis’ ANDA for up to 30 months from the date the plaintiffs received notice of Actavis’ ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
Based on available information, Actavis believes it may be a “first applicant” to file an ANDA for the generic version of Neupro and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
For the 12 months ending June 30, 2014, Neupro had total US sales of approximately $85 million, according to IMS Health data.