BRAND COMPANIES WIN, GENERICS LOSE IN OXYCONTIN, RISPERDAL PATENT DECISIONS

Several generic companies have come up short in their attempt to get into the Oxycontin and Risperdal market due to two court rulings announced Oct. 16.

The U.S. District Court for the Southern District of New York dismissed patent infringement litigation for Teva Pharmaceutical's generic version of Purdue Pharma's Oxycontin (oxycodone HCl extended-release) Tablets after the two companies reached a settlement.

The agreement calls for Teva to stop selling its generic oxycodone drug at a date yet to be determined. In return, Purdue will not pursue litigation against Teva for previous patent infringements. Other terms of the settlement were not disclosed.

In another case, U.S. District Court Judge John Lifland upheld a patent for Janssen's Risperdal (risperidone), preventing generic versions of the drug from entering the market until the patent expires in 2007.

The FDA had already given tentative approval to one generic form of Risperdal from Mylan Pharmaceuticals and Dr. Reddy's Laboratories. Because of the court's ruling, the FDA must change the effective date for approval of that version until after Dec. 29, 2007, when Janssen's patent expires. The market will also be open for other generic versions of the drug after that date.

Janssen filed the complaint in Dec. 2003, saying Mylan's generic version violated its patent. Mylan and Dr. Reddy's did not dispute the violation during the trial.