Ranbaxy Laboratories Limited (Ranbaxy) announced that the US District Court for the District of Northern Illinois has ruled for Ranbaxy on two patents and against Ranbaxy on a single claim of a third patent. The court preliminarily enjoined Ranbaxy from marketing its clarithromycin, one gram extended release product.
According to the company release, while this decision does not apply to the 500 mg ER product, the court's ruling provided clear direction for the changes in Ranbaxy's labeling to make both products non infringing. Ranbaxy will be entering into discussions with FDA to amend its labeling for the as-yet unapproved 500 mg ER tablet to remove language that implicates the single claim at issue in the third patent. The judge's opinion will be taken into consideration in these discussions with FDA and when amending the labeling for the 500 mg ER formulation such that Ranbaxy can launch the 500 mg ER tablets immediately upon approval.
According to Malvinder M. Singh, President & Executive Director, Ranbaxy, "The ruling on Clarithromycin 1000 mg ER does not impact Ranbaxy's plan to introduce Clarithromycin 500 mg ER which, subject to US FDA approval, remains on-course."
Clarithromycin tablets are indicated for the treatment of a wide variety of bacterial respiratory tract infections, including chronic bronchitis and acute maxillary sinusitis.