Supernus Pharmaceuticals, Inc.
) recently announced the filing of a patent infringement lawsuit
). Actavis is looking to launch its generic version of Oxtellar
XR - an antiepileptic drug.
With the patent infringement lawsuit being filed in the U.S.
District Court for the District of New Jersey within 45 days of
the receipt of the paragraph IV certification notice, the U.S.
Food and Drug Administration (FDA) cannot grant final approval to
the generic versions of Oxtellar XR before 30 months.
The challenged patents are scheduled to expire on Apr 13,
Oxtellar XR is an extended release formulation of
oxcarbazepine. Oxtellar XR is an antiepileptic drug indicated for
adjunctive therapy for the treatment of partial seizures in
adults and in children 6 to 17 years of age.
Oxtellar XR is the sole marketed product in Supernus'
portfolio, which was launched in Feb 2013 in the U.S. In Nov
2012, Supernus had received three years of marketing exclusivity
from the FDA. As of Mar 31, 2013, net deferred product revenue
was $3.6 million. In the first two months of its launch,
prescriptions totaled 579.
Supernus has an agreement with Patheon Inc. for the
manufacture, formulation, development and supply of
commercial-grade quantities of oxcarbazepine, the active
pharmaceutical ingredient in Supernus' Oxtellar XR, in the U.S.
As per the terms of the commercial supply agreement, Patheon will
manufacture (including processing, packaging and labeling)
oxcarbazepine at its facility. Supernus will provide Patheon with
all relevant materials required for manufacturing the
Supernus carries a Zacks Rank #3 (Hold). Currently, companies
Questcor Pharmaceuticals Inc.
Anika Therapeutics Inc.
) look well-positioned with a Zacks Rank #1 (Strong
ACTAVIS INC (ACT): Free Stock Analysis Report
ANIKA THERAPEUT (ANIK): Free Stock Analysis
QUESTCOR PHARMA (QCOR): Free Stock Analysis
SUPERNUS PHARMA (SUPN): Free Stock Analysis
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