FDA is dragging its feet over oxycodone generics

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FDA is dragging its feet over oxycodone generics

Generics/General | Posted 19/04/2013 0 Post your comment

The US patent for Purdue Pharma’s (Purdue’s) blockbuster painkiller OxyContin (oxycodone) expired on 16 April 2013, but FDA has yet to approve any generic versions. Now, FDA has announced that it will not approve any generics of the original formulation OxyContin.

The problem is that oxycodone is a potent opioid, which is prone to abuse. To try to combat this, back in 2010 FDA approved a new formulation of the controlled-release drug from Purdue. This new version was designed to help discourage misuse and abuse of the medication by infusing the drug with a polymer, which prevents the opioid medication from being cut, broken, chewed, crushed or dissolved to release more medication.

Generics manufacturers Impax Laboratories, Mallinckrodt (the generic division of Covidien) and Teva Pharmaceutical Industries have all submitted abbreviated new drug applications (ANDAs) to FDA for approval of their own generic versions.

FDA has now said that it will not approve any ANDAs that rely on the approval of the original OxyContin. The agency had been coming under increasing pressure to require generics drugmakers to also incorporate some kind of tamper resistance into their oxycodone formulations. So the question is whether generics manufacturers will be allowed to make generics of the newer version designed to prevent abuse. The only problem there is that Purdue’s reformulated abuse-resistant version has patent protection until 2025. Another possibility could be that generics makers could be allowed to make generic versions with their own abuse deterrents.

The FDA’s decision is not welcome by patients. Mr David Gaugh, Senior Vice President at the Generic Pharmaceuticals Association (GPhA) said that delaying generic drugs could mean ‘leaving behind the millions of patients who stand to benefit from access to lower cost versions’ of OxyContin.

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Source: FDA, The Wall Street Journal