In the suit, Acura alleges that a generic of Acura’s AVERSION oxycodone product, previously marketed by Pfizer under its brand name OXECTA, for which Ranbaxy is seeking approval to market in the US pursuant to an Abbreviated New Drug Application (ANDA) filing with the US Food and Drug Administration (FDA) infringes US 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.
Acura president and CEO Bob Jones noted that based on the current formulation approach of Ranbaxy’s generic product, we determined that settlement of the suit was advisable.
"The FDA now must determine if Ranbaxy’s product has abuse deterrent features comparable to our AVERSION® oxycodone product or can match the our AVERSION® oxycodone product label," Jones added.