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First-to-File Status Will Provide 180-Day Marketing Exclusivity Upon Final Approval
Gurgaon , India | June 25, 2008 | Ranbaxy Laboratories Limited (RLL), announced today that the company has received tentative approval from the U.S. Food and Drug Administration 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.
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.
Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, USA, is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India’s largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.
Ranbaxy Laboratories Limited, India 's largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy’s continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company’s foray into Novel Drug Delivery Systems has led to proprietary "platform technologies," resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.
SOURCE: Ranbaxy Laboratories Limited |
