Impax Gets OK on Generic OxyContin

Impax Laboratories Inc. on Wednesday said U.S. regulators gave tentative approval to its copy of Purdue Pharma’s OxyContin, a painkiller that has been the subject of more than 100 consumer lawsuits claiming it is addictive.

Impax, which specializes in making controlled-release generic drugs, still needs to win a patent lawsuit brought by closely held Purdue Pharma and wait for the expiration of any generic marketing exclusivity, the Hayward, Calif.-based company said.

Israel’s Teva Pharmaceutical Industries Ltd., the world’s biggest generic drug maker, got tentative Food and Drug Administration approval for a version of OxyContin in September. The FDA gave tentative approval for a version made by Endo Pharmaceuticals Holdings Inc. in August 2002. A Purdue spokesman has said the company also was challenging these filings.

Reports of OxyContin abuse have led federal regulators to tighten restrictions on access to the drug, which is prescribed to terminal cancer patients and chronic pain sufferers.

Shares of Impax rose 47 cents to $14.66 on Nasdaq.

At the start of the month, Purdue said 16 consumer lawsuits against it were dismissed in a two-month period and that it was no longer facing lawsuits in seven states where it had been sued over patients’ injuries from taking the drug.

The company said it had not paid plaintiffs anything in 65 cases against it that have been dismissed.

Purdue, based in Stamford, Conn., has sold OxyContin since 1996. Abbott Laboratories helps market the drug.

Impax said NDC Health Corp. estimated that U.S. sales of the drug were $1.18 billion for the 12 months ended Oct. 31.