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

Acura Pharmaceuticals, Inc., a specialty pharmaceutical company developing products intended to address medication abuse and misuse, announced today that it has entered into distinct Settlement Agreements with each of Par Pharmaceutical and Impax Laboratories, 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. Acura currently has Orange Book patents that are due to expire between November 2023 and March 2025. In certain limited circumstances, Acura's license to Par would become effective prior to 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 (or if no entity is entitled to such 180 day exclusivity period, the date on which a generic Oxecta® product is first sold in the U.S. or November 27, 2021, whichever date occurs first). In certain circumstances, Acura's license to Impax would become effective prior to such time.

Acura's President and CEO, Bob Jones said, "We are very pleased with these results, which reflect our continued confidence in the strength of our patents while removing the uncertainty, distraction and cost of litigation."

The Settlement Agreements provide for a full settlement of all claims that were asserted in each of the Par and Impax suits, subject to the Court's acceptance of the stipulations of dismissal. As required by law, the Settlement Agreements with Par and Impax will be submitted to the U.S. Federal Trade Commission and US. Department of Justice.