Several things must happen before generic extended-release oxycodone can enter the market when Purdue Pharma LP’s method of treatment patent on the original version of OxyContin expires April 16: FDA must determine that the company’s withdrawal of the drug from the market was not for safety reasons and give final approval to one or more generic products, and the generic sponsor(s) must either launch at-risk or win a patent challenge relating to the use of low-impurity oxycodone.
An at-risk launch would be necessary in the absence of a court decision on the patents for the low impurity...