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Acura Pharmaceuticals Inc Announces Settlement of Oxecta Patent Litigation With Par Pharmaceutical and Impax Laboratories Inc


Wednesday, 9 Oct 2013 04:10pm EDT 

Acura Pharmaceuticals Inc announced that it has entered into distinct Settlement Agreements with each of Par Pharmaceutical and Impax Laboratories Inc, to settle Acura's patent infringement action pending against them in the United States District Court for the District of Delaware. In the suit, Acura alleges that a generic Oxecta product for which each of Par and Impax is separately seeking approval to market in the United States pursuant to an Abbreviated New Drug Application (ANDA) filing with the U.S. Food and Drug Administration (FDA) infringes a U.S. patent owned by Acura. Par is the first filer of an ANDA for a generic Oxecta product and is entitled to the 180-day first filer exclusivity under applicable law and FDA regulations. Under the terms of the Settlement Agreement with Par, Par may launch its generic Oxecta product in the U.S., through the grant of a non-exclusive, royalty-bearing license from Acura to Par that would trigger on January 1, 2022. Par is required to pay Acura royalties in the range of 10% to 15% of Par's net profits from the sale of its generic Oxecta product. Under the Settlement Agreement, Impax may launch its generic Oxecta product in the U.S., through the grant of a non-exclusive, royalty-free license from Acura to Impax that would trigger 180 days following the first sale of a generic Oxecta product in the U.S. by an entity that is entitled to the 180 day first-filer exclusivity under applicable law and FDA regulations. 

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