Acura Pharma Enters Into Settlement Agreement With Ranbaxy - Quick Facts

(RTTNews) - Acura Pharmaceuticals Inc. (ACUR) announced Thursday that it has entered into a Settlement Agreement with Ranbaxy Inc. to dismiss, without prejudice, its patent infringement action pending against Ranbaxy in the United States District Court for the District of Delaware. In the suit, Acura alleges that a generic of Acura's AVERSION oxycodone product, previously marketed by Pfizer Inc. under its brand name OXECTA, for which Ranbaxy is 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 U.S. patents owned by Acura.

The Settlement Agreement provides that Ranbaxy's current product that is the subject of its ANDA does not infringe Acura's Orange Book listed patents with the FDA. Acura has not provided Ranbaxy with a license to Acura's patents and Acura may re-commence patent infringement litigation against Ranbaxy if Ranbaxy changes the formulation of its generic to the AVERSION oxycodone product.