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
) which is facing a patent challenge from Actavis (
) 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
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.
UCB and Actavis carry a Zacks Rank #3 (Hold) stock. Some
better-ranked stocks in the health care sector include Mallinckrodt
) and Akorn, Inc. (
). Both sport a Zacks Rank #1 (Strong Buy).
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