Healthcare Industry News:  Valtrex 

Biopharmaceuticals Litigation

 News Release - July 26, 2007

Ranbaxy and GlaxoSmithKline Enter Into an Agreement to Settle Valacyclovir U.S. Patent Litigation

Ranbaxy to Launch Valacyclovir Hydrochloride Tablets in Late 2009 With 180 Days Exclusivity

PRINCETON, N.J., July 26 (HSMN NewsFeed) -- Ranbaxy Laboratories Limited (RLL) announced today that the Company has reached an agreement with GlaxoSmithKline (GSK) resulting in a dismissal of their U.S. litigation with regard to Valtrex (Valacyclovir Hydrochloride tablets). The lawsuit in the U.S. was related to GSK's U.S. Patent No. 4,957,924, covering Valacyclovir Hydrochloride which is used in the treatment of herpes virus infection.

Under the agreement, Ranbaxy will enter the U.S. market in late 2009, whereby as the first generic company to file, it will enjoy a 180 days sales exclusivity. Ranbaxy has also obtained a license to GSK's U.S. Patent Nos. 5,879,706 and 6,107,302, listed in the Orange Book for Valacyclovir. The total annual sales of Valtrex were around $1.3 Bn (source IMS - MAT: Dec. 2006).

In early February 2007, Ranbaxy received a final approval from the U.S. FDA to market and manufacture Valacyclovir Hydrochloride tablets.

Ranbaxy will continue to pursue a strategy to effectively leverage and monetize it's pipeline of First-to-File (FTF) opportunities. The Company believes that it has a FTF status on approximately 20 Para IV ANDA filings, representing a market size of $26 Bn valued at innovator prices.

Ranbaxy Laboratories Limited, the largest pharmaceutical company in India, 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

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