In what one analyst called a "significant negative" for beleaguered Andrx, a federal court has granted Abbott Laboratories a preliminary injunction blocking Andrx and Ranbaxy Laboratories from marketing generic versions of Biaxin XL. The U.S. District Court for the Northern District of Illinois issued the recent injunction.
Abbott's Biaxin XL (clarithromycin) is an antibiotic indicated for the treatment of certain respiratory bacterial infections.
Banc of America Securities analyst David Maris had forecast Andrx would make $15 million from its launch of generic Biaxin XL in the fourth quarter and approximately $45 million in 2006, but is now "removing these sales from both years as we await more clarity on the timing and outcome of the formal court case," he writes in a research note.
Biaxin XL accounted for roughly two-thirds of the $458 million in total U.S. Biaxin sales in 2004, an Abbott spokeswoman told FDAnews.
Andrx said it is "evaluating the court's decision and will determine its course of action." Abbott said it expects a patent infringement trial to take place sometime in 2006.
The injunction is the latest blow against Andrx, which recently had its pending abbreviated new drug applications and one new drug application put on hold by the FDA due to manufacturing problems.
Andrx is scheduled to meet with the FDA in late November to discuss the manufacturing issues. The FDA must re-inspect Andrx's plant before approving any pending applications, Andrx said.