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FDA Blocks Generic Versions of OxyContin

The patent on original OxyContin expired yesterday.  That’s big news in the pharma world.  OxyContin had $2.8 billion in sales last year.  Generic drug manufacturers normally would pounce on the chance to enter the market, but the FDA had other plans.

Late Tuesday, the U.S. Food and Drug Administration announced that it “will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of original OxyContin.”

The FDA approved new labeling information for the reformulated version of OxyContin.  That means that all generic versions of the painkiller must include the new, abuse-deterrant properties of OxyContin. The new labeling indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting).

Essentially, the FDA decision protects Purdue Pharma L.P. (maker of OxyContin) from lower-price competition by requiring generic drug makers to develop their own abuse-deterrent designs.  There will not be any generic versions of the original OxyContin.

“The development of abuse-deterrent opioid analgesics is a public health priority for the FDA,” said Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “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.”

The FDA has determined that the reformulated product has abuse-deterrent properties. The tablet is more difficult to crush, break, or dissolve. It also forms a viscous hydrogel and cannot be easily prepared for injection. The agency has determined that the physical and chemical properties of the reformulated product are expected to make the product difficult to inject and to reduce abuse via snorting.

However, abuse of OxyContin by these routes, as well as the oral route, is still possible. The reformulated product also may reduce incidents of therapeutic misuse, such as crushing the product to sprinkle it onto food or to administer it through a gastric tube. When FDA finds that a new formulation has abuse deterrent properties, the agency has the authority to require generics to have abuse-deterrent properties also.

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