Ranbaxy Laboratories Limited (RLL) has received tentative approval from the US Food and Drug Administration (FDA) to manufacture and market valganciclovir hydrochloride tablets, 450 mg. Total annual market sales for valganciclovir HCl tablets were $239 million (IMS - MAT: March 2008).
Ranbaxy believes that it has First-to-File status on valganciclovir tablets, thereby providing a potential of 180-days of marketing exclusivity, offering a significant opportunity in the future, a company press release said.
Valganciclovir HCl tablets are indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). Valganciclovir HCl is also indicated for the prevention of cytomegalovirus (CMV) disease in kidney, heart and kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [(D+/R-)]).
"Ranbaxy is pleased to receive this tentative approval for valganciclovir hydrochloride tablets, a medicine that has established its clinical value and utility over time. It will be launched by Ranbaxy upon receiving final approval and resolution of litigation currently pending in Federal District Court, as an affordably priced alternative to the branded product, Valcyte. This product formulation will further expand our portfolio of affordable generic alternatives and will be available to all classes of trade," said Bill Winter, vice president of trade sales for RPI, USA. "This represents another potentially strong market entry for Ranbaxy medicines from among our pipeline of patent challenges, and offers us a significant future opportunity," Winter added.