Teva Pharmaceutical Industries has won the latest round of its battle to sell a generic version of Abbott Laboratories’ top selling drug, the extended-release antibiotic Biaxin (clarithromycin), after a US court of appeals overturned a previous preliminary injunction.
The Israeli group has already obtained approval from the US Food and Drug Administration to market 250mg and 500mg doses of immediate-release clarithromycin as well as a 500mg version of the extended-release form, but was prohibited from rolling out its products until the outcome of the patent infringement case brought by Abbott.
In June last year, a judge in Illinois granted Abbott's motion for a preliminary injunction preventing the sale Teva’s generic, a ruling which has now been vacated by the appeals court, thereby opening the door to a fairly lucrative market.
Biaxin is used to treat upper and lower respiratory and skin infections, and generates yearly revenues of around $1.2 billion for Abbott. But the drug hit the headlines last year when US regulators issued an alert after a Danish study linked its use to a higher chance of death from heart problems. No label changes were recommended on the back of the study’s findings.