Ranbaxy, which won two patent claims at US Court of Northern Illinois, however lost the third one that pertains to labelling and can now launch the drug (1,000 mg extended release) in US only after amending the label.
"A US district court for the district of northern Illinois has ruled for the company on two patents and against the company on a single claim of a third patent. The court preliminarily enjoined the company from marketing its clarithromycin, one gram extended release product.
"While this decision does not apply to the 500 mg ER product, the courts ruling provided clear direction for the changes in the company's labelling to make both products non infringing," a Ranbaxy statement said in New Delhi.
The company will be entering into discussion with Food and Drug Administration to amend its labelling 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 discussion with FDA and when amending the labelling for the 500 mg ER formulation such that the company can launch the 500 mg ER tablets immediately upon approval.
According to company Malvinder M Singh, president and executive director, "The ruling on clarithromycin 1,000 mg ER does not impact Ranbaxy's plan to introduce clarithromycin 500 mg ER which, subject to USFDA approval, remains on-course."
