Actavis will be able to market a limited amount of its generic abuse-deterrent oxycodone from 1 January 2014, assuming the company obtains FDA approval. However, if Actavis is unable to gain FDA approval for its generic abuse-deterrent oxycodone prior to 1 September 2014, it will be licensed to sell a limited amount of an authorized generic drug from October 2014.

Actavis anticipates that the agreement will represent more than US$100 million in combined gross profit in 2014 and 2015, more heavily weighted to 2014. The agreement is expected to result in a more modest contribution from 2016 through 2019.

Mr Paul Bisaro, President and CEO of Actavis, said that the agreement ‘eliminates the uncertainty surrounding FDA review and approval of generic versions of abuse-deterrent products. Consumers and Actavis shareholders will now benefit from the distribution of product beginning in 2014.’

OxyContin had US sales of approximately US$2.8 billion for the 12-month period ending 31 January 2013, according to IMS Health.

This comes as good news for patients. FDA announced on 16 April 2013 that it would not grant approval to any oxycodone generics that rely on the approval of the original ‘non-abuse-deterrent’ formulation of OxyContin, despite the fact that Purdue’s patent on the original formulation expired on that day [1]. It was therefore feared that patients would have to wait until 2025 for generics of the painkiller. Purdue has patent protection on its new abuse-resistant formulation, which is infused with a polymer, which prevents the opioid medication from being cut, broken, chewed, crushed or dissolved to release more medication, until 2025.

Reference

1.  GaBI Online - Generics and Biosimilars Initiative. FDA is dragging its feet over oxycodone generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 May 3]. Available from: www.gabionline.net/Generics/General/FDA-is-dragging-its-feet-over-oxycodone-generics

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