Acura settles Oxecta dispute with Ranbaxy

Acura Pharmaceuticals and Ranbaxy have agreed to settle their patent infringement litigation related to painkiller Aversion (oxycodone hydrochloride), once marketed by Pfizer under its registered trademark Oxecta.

Aversion is an abuse deterrent formulation of the opioid oxycodone, which can cause dependence in patients. It contains polymers that cause the drug to gel when dissolve, and compounds that irritate the nasal passages.

The patent at suit, 7,510,726, covers methods and compositions for deterring abuse of opioid containing dosage forms. It is due to expire in November 2023.

The settlement agreement provides that Ranbaxy’s generic does not infringe the ‘726 patent, which is held by Acura. Acura said that as it has not provided a licence to Ranbaxy, it may recommence the patent infringement litigation if Ranbaxy changes the formulation of its Oxecta generic.

“Based on the current formulation approach of Ranbaxy’s generic product, we determined that settlement of the suit was advisable,” said Bob Jones, Acura’s president and chief executive.

“The FDA [US Food and Drug Administration] now must determine if Ranbaxy’s product has abuse deterrent features comparable to our Aversion oxycodone product or can match the Aversion oxycodone product label.”

Acura brought the action at the US District Court for the District of Delaware in April last year, after Ranbaxy filed an Abbreviated New Drug Application with the FDA for approval to market a generic version of the drug.

Six months before, Acura had filed similar suits against generic drug makers Watson Laboratories, Par Pharmaceutical, Impax Laboratories and Sandoz.

Last month it emerged that Sun Pharma would acquire Ranbaxy for $3.2 billion, though according to reports, the transaction has been halted by a court until complaints of insider trading have been investigated.