FDA acts quickly on blocking OxyContin generics

Purdue Pharma has patents for two versions of the name-brand oxycodone painkiller: the original version, which pharmacies haven’t been selling since 2010, and a newer kind that resists being crushed or dissolved.

On Tuesday, after Purdue’s patent for the first version of the drug expired, the FDA swiftly recalled the medication “for safety reasons.” That move will prevent other companies from swooping in and creating a generic version of the drug. The FDA cannot approve patents for drugs it has withdrawn.

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

The OxyContin with “abuse deterrent properties” that Purdue began selling nearly three years ago is more difficult to crush, break or dissolve, according to federal regulators. The pill resists being prepared for injection by turning into a sticky gel.

Companies had been waiting for Purdue’s original patent to expire, hoping to cash in on the popularity of the drug. In 2010, sales of OxyContin topped $3 billion in the United States alone.

But now that the FDA has withdrawn its approval of the original version, drug companies will have to wait until 2025, when Purdue’s patent for the more technologically savvy painkiller expires.