On April 16, the FDA announced they will not approve generic versions of the original formulation of OxyContin. New ANDAs for the original OxyContin formulation will not be accepted since the product was removed from the market for safety reasons and cannot serve as a reference product for generic products. This decision comes after the FDA approved Purdue Pharma’s new labeling for reformulated abuse resistant OxyContin. The new labeling includes claims that the drug will reduce abuse because it is difficult to break down so drug addicts can’t inject or snort the product.  Purdue Pharma has several patents on reformulated OxyContin, with the latest expiring in 2025. Other opioid suppliers, such as Endo Pharmaceuticals, are also hoping to gain abuse-deterrent labeling on their reformulated products.

PHSI agrees with the FDA’s decision to remove the original OxyContin product from the Orange Book due to safety reasons. As opioid abuse continues to be a problem across the nation, PHSI believes that manufacturers will develop abuse-deterrent formulations with FDA guidance.  The FDA may receive some negative feedback for limiting the public access to cheaper generic drugs. This decision by the FDA indicates they are committed to safe and effective drug therapy.

Update: On April 26, Actavis, Inc. and Purdue Pharma reached a patent challenge settlement which allows Actavis to market a limited number of bottles of generic reformulated OxyContin beginning January 1, 2014. Actavis will need to receive FDA approval before launching the product. The settlement also includes the stipulation that if Actavis does not gain FDA approval by September 1, 2014, they may launch a limited number of bottles as an authorized generic of OxyContin beginning in October 2014.