Actavis confirms patent challenge for generic Neupro

23 August 2014

Ireland-headquartered generics major Actavis (NYSE: ACT) on Friday confirmed that it has filed an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval to market rotigotine extended-release transdermal film.

Actavis' ANDA product is a generic version of Belgian drugmaker UCB’s (Euronext Brussels: UCB), 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 US Patents.

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