GSK Ceftin patent ruling

Executive Summary

Apotex is barred from manufacturing generic cefuroxime axetil tablets until two GSK patents on the antibiotic expire on July 29, a Chicago federal judge rules May 1. Judge Robert Gettleman says Apotex' generic would infringe GSK patents claiming an amorphous form of cefuroxime axetil and a spray drying process. Apotex' ANDA received FDA approval in October 2002, but the drug was never marketed because the company has been subject to a preliminary injunction since June 2002. Patent litigation between GSK and Ranbaxy, which markets the only generic cefuroxime tablet on the market, is ongoing, with a bench trial scheduled for July in Trenton, N.J. federal court...