2014

Ranbaxy Gains Tentative Approval to Manufacture and Market Valganciclovir Hydrochloride Tablets 'First-to-File' Status Will Provide 180-Day Marketing Exclusivity Upon

Final Approval



    PRINCETON, N.J., June 25 /PRNewswire/ -- 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.
 
 
* Valcyte(R) is a registered trademark of Roche Chuck Caprariello Vice President, Corporate Communications and Government Affairs Ranbaxy Inc. (609) 720-5615 Edwige Buteau RF Binder (212) 994-7517 Caroline Dickson RF Binder (212) 994-7560

SOURCE Ranbaxy Laboratories Limited

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