Supernus Pharmaceuticals, Inc. (SUPN) recently announced the filing of a patent infringement lawsuit against Actavis, Inc. (ACT). 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, 2027.
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 product.
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