U.S. Clears India’s Ranbaxy For Generic Of Roche’s Valycyte
This article was originally published in PharmAsia News
Executive Summary
The U.S. FDA has tentatively cleared India's Ranbaxy Laboratories to market a generic of Roche's Valcyte (velganciclovir) for treating an eye problem in AIDS patients. As the first company to apply for generic clearance, Ranbaxy gets six months of exclusivity on the U.S. market once Roche's patent expires in 2015. The drug is intended to treat cytomegalovirus retinitis, a disease that afflicts patients with AIDS, and for cytomegalovirus in heart, kidney and kidney-pancreas transplant patients. Roche has filed a suit alleging Ranbaxy is infringing on its patent for Valcyte. (Click here for more