Innovator companies, which have spent millions on the development of branded drugs, often face patent challenges from companies looking to bring in generic versions of the drug prior to the loss of patent exclusivity. In such a scenario, the innovator companies usually file a patent infringement lawsuit against the generic company to delay the entry of generic versions.
A similar step was taken late last week by UCB (UCBJF) which is facing a patent challenge from Actavis (ACT) for Neupro. Actavis has filed an Abbreviated New Drug Application (ANDA) with the FDA seeking marketing approval for its generic version of UCB’s Neupro (1 mg/24 hr, 2mg/24 hr, 3 mg/24hr, 4 mg/24 hr, 6mg/24hr, and 8 mg/24 hr).
UCB filed a lawsuit against Actavis in the U.S. District Court for the District of Delaware in order to prevent Actavis from commercializing its generic version of Neupro prior to the expiration of certain U.S. patents.
Neupro is approved for the treatment of signs and symptoms of idiopathic Parkinson's disease and moderate-to-severe primary restless legs syndrome (:RLS).
With the lawsuit being filed under the provisions of the Hatch-Waxman Act, the FDA cannot grant final approval to Actavis’ generic version for up to 30 months from the date the notice was received notice by UCB about the ANDA filing or until final resolution of the matter before the court, whichever occurs sooner.
Actavis believes it is “first to file” an ANDA for a generic version of Neupro and might be entitled to 180 days of generic market exclusivity if the FDA approves the ANDA.
As per IMS Health data, Neupro generated sales of $85 million in the last 12 months, ending Jun 30, 2014, in the U.S.