Acura ends all Aversion litigation with final Sandoz settlement

US-based drug company Acura and Novartis’s generic arm Sandoz have settled their patent infringement dispute related to an abuse-deterrent formulation of the painkiller Aversion (oxycodone).

The settlement, which comes two weeks after Acura agreed with Indian pharmaceutical company Ranbaxy to end litigation related to the same drug, also ends all pending patent litigation against the generic companies that filed Abbreviated New Drug Applications (ANDAs) to market their own Aversion generics.

The other ANDA filers are Watson Laboratories, Par Pharmaceutical and Impax Laboratories.

Aversion is a formulation of oxycodone that deters abuse by forming a gel when dissolved in solvents for injection and causing nasal discomfort if crushed and snorted.

Acura filed the case at the US District Court for the District of Delaware, alleging that Sandoz infringed its patent with a generic version of Aversion.

The settlement, announced on May 21, allows Sandoz to launch its generic in the US through a licence granted by Acura.

The licence will come into effect 180 days after the first sale of an Aversion generic by the first company that filed an ANDA to sell such a product.

It is not yet known which of the companies first filed an ANDA.

Under the agreement, Sandoz does not have to pay Acura a royalty if its generic is approved by the US Food and Drug Administration (FDA). However if it changes the formulation disclosed in the ANDA filing, it must to pay Acura 7 percent of its Aversion generic net profits as a royalty.

Bob Jones, president and chief executive of Acura, said: “We are very pleased to have now concluded all our patent infringement suits concerning Aversion oxycodone.

“We still await the FDA’s guidance on what these generic ANDA filers must do to gain approval on a product considered to be equivalent to our Aversion oxycodone in terms of both efficacy and safety.”