Ranbaxy wins two patent cases in the US

Adding to the feverish pharmaceutical litigation activity globally, a US District Court has ruled for Ranbaxy Laboratories Ltd on two patents and against it on a third one on Clarithromycin's 1000 mg extended release (ER) product.

Indicated for bronchitis and acute sinusitis, this drug is estimated to have a market of $300 million and its patented version is sold as Biaxrin by Abbott Laboratories.

According to the company release stating the development, the Northern Illinois court's ruling has provided direction for labelling changes in the Indian drug maker's product to make it non-infringing.

The company already has the Abbreviated New Drug Application (ANDA) approved and the launch would be sooner than later, said a company spokesperson.

Although this ruling has no bearing on Ranbaxy's as-yet unapproved Clarithromycin 500 mg ER, the company is planning to enter into discussions with US Food and Drug Administration (USFDA) to amend its labeling too.

According to Malvinder M Singh, executive director, Ranbaxy said, "The ruling on Clarithromycin 1000 mg ER does not impact Ranbaxy's plan to introduce Clarithromycin 500 mg ER which, subject to USFDA approval, remains on course."