Clinical Alert: Generic OxyContin Delayed till 2025

by myMatrixx

The FDA has announced that it will not approve generic versions of the original formulation of OxyContin. OxyContin was first approved by the FDA in December of 1995. The patent on that product expired yesterday. However Purdue Pharma, the manufacturer of OxyContin, ceased distribution of the original formula in August of 2010. In April of that same year the FDA approved a reformulated version of OxyContin, “which was designed to be more difficult to manipulate for purposes of misuse or abuse,” according to the FDA. The original formula of OxyContin was subject to significant misuse and abuse; whereas the reformulated version has been determined by the FDA to have “abuse-deterrent properties” and when the FDA finds that a new formulation has abuse deterrent properties, the agency has the authority to require generics to have abuse-deterrent properties also.

This decision by the FDA is important to minimize intentional misuse and abuse of long-acting Opioids like OxyContin. As stated by Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research: “The development of abuse-deterrent opioid analgesics is a public health priority for the FDA. While both original and reformulated OxyContin are subject to abuse and misuse, the FDA has determined that reformulated OxyContin can be expected to make abuse by injection difficult and expected to reduce abuse by snorting compared to original OxyContin.”

As a result of this decision, generic companies that were waiting for the patent to expire on the original formulation of OxyContin will now have to wait until 2025 to launch a generic version of the reformulated product.

This decision may also impact other long acting Opioid products that have undergone re-formulation. In a recent article Bloomberg News reported that Endo Pharmaceuticals, the maker of Opana and Opana ER, has filed a similar request with the FDA regarding Opana (oxymorphone). If the FDA issues a similar ruling this could remove the generic version from the market, however, only time will tell.

The myMatrixx Clinical Team will continue to monitor this topic and provide updates as appropriate. For more information on this notice visit  Federal Register Notice or FDA Actions on OxyContin Products.