- Ireland-based Actavis has filed an abbreviated new drug application (ANDA) with the FDA to market rotigotine extended-release transdermal film -- a generic version of UCB Pharma's Neupro.
- Rotigotine is used for the treatment of symptoms of idiopathic Parkinson’s disease and moderate-to-severe restless legs syndrome (RLS).
- UCB Pharma, along with UCB Manufacturing Ireland and LTS Lohmann Therapie-Systeme (the Neupro patent holders), is suing Actavis to stop commercialization of rotigotine before expiration of certain US patents. The plaintiffs have received a stay from a federal district court in Delaware.
Actavis is seeking to market rotigotine ER transdermal film in four doses, ranging from 1 mg to 8 mg administered over a 24-hour period.
UCB Pharma and its partners filed the lawsuit under provisions of the Hatch-Waxman Act. The district court has issued a stay of final FDA approval for Actavis’ ANDA for up to 30 months.