Acura sues Ranbaxy over abuse-resistant generic

Acura Pharmaceuticals has sued Ranbaxy Laboratories to keep it from releasing a generic version of its immediate release tablet formulation of painkiller Oxecta.

Oxecta is an abuse-resistant form of the opioid painkiller oxycodone. Oxycodone is also the active ingredient in OxyContin, which the FDA recently said it would no longer approve generic versions of.

The lawsuit brought by Acura concerns the ‘726 patent, which covers “methods and compositions for deterring abuse of opioid containing dosage forms”.

In its complaint, Acura claims Ranbaxy plans to commercially manufacture use and sell oxycodone hydrochloride tablets of 5mg and 7.5mg under the name Ranbaxy’s Oxycodone HCI Tablets in the US before the ‘726 patent expires in 2025.

The US Patent and Trademark Office issued Acura the ‘726 patent in March 2009. The US Food and Drug Administration (FDA) approved the drug in 2011.

Ranbaxy has claimed that Acura’s ‘726 patent is invalid in its notice letter, though does not provide any reason for its invalidity.

Peter Corless, a partner at Edwards Wildman Palmer LLP in Boston, said that while this is required according to FDA rules, it is not likely to weaken Ranbaxy’s case, as Acura did not contest improper notice at the time of filing it case.

He described the case as “unique”, as it deals with the abuse-deterrent formulation of the drug:

“All the claims are directed to composition – the analgesic in combination with other materials,” he said. It is an infringing product as it “sits on the shelf.”

He said that Acura has another case pending concerning additional patents that aren’t brought up in this particular case.

“It’s common, in the case of a drug product, for a company to have an application in reserve,” he said.

“In litigation if an issue comes up about one of your claims being deficient in some respect, you have a fallback that allows you to issue new claims that respond to that criticism.”

The brands v generics battle is a hot topic in the US, with politicians promoting the generic pharmaceutical industry to increase access to different drugs, he said.

However there may be bumps in the road: “The generic drug industry doesn’t come up with new drugs so if you undercut the innovative companies, [in a worst-case scenario] there may not be any new drugs in the future,” he said.