FDA Bans Generics of Purdue's Older OxyContin Painkiller

Generic-drug companies will be barred from making copies of older versions of OxyContin that don’t have tamper-resistant qualities, U.S. regulators said.

The Food and Drug Administration determined today that closely held Purdue Pharma LP, maker of a reformulated OxyContin, pulled previous versions of the popular painkiller without abuse-deterrent measures from the market for safety or effectiveness reasons. The determination will keep generic drugmakers such as Teva Pharmaceutical Industries Ltd. (TEVA) and Impax Laboratories Inc. (IPXL) from making copies of the older version.

The patent expires today for Stamford, Connecticut-based Purdue Pharma’s original formulation of OxyContin. Endo Health Solutions Inc. (ENDP) has also filed a similar request with FDA regarding the safety of its old painkiller Opana. An FDA ruling could remove Impax’s generic version from the market.

“The data show that, when compared to original OxyContin, reformulated OxyContin has an increased ability to resist crushing, breaking, and dissolution using a variety of tools and solvents,” FDA said in the notice posted in the Federal Register.

Purdue Pharma pulled original OxyContin in August 2010, the FDA said.

Endo, based in Chadds Ford, Pennsylvania, gained 4.8 percent to $36.52 in extended trading at 4:47 p.m. New York time after the FDA’s announcement. The shares had increased 1.7 percent during regular trading to close at $34.86.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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