Healthcare Industry News:  Generic Pharmaceutical Association 

Biopharmaceuticals Generics Litigation

 News Release - November 15, 2006

Ranbaxy Granted Favorable Decision by the U.S. Court of Appeals Regarding Marketing Exclusivity for Simvastatin 80mg

Decision has wide-ranging implications for Ranbaxy as well as other generic pharmaceutical manufacturers

PRINCETON, N.J., Nov. 15 (HSMN NewsFeed) -- Ranbaxy Laboratories Limited (RLL) today announced that the U.S. Court of Appeals for the District of Columbia Circuit has affirmed an earlier District Circuit holding on Simvastatin, preserving 180-day exclusivity when patents are delisted from the FDA Orange Book.

Earlier, Merck & Co., Inc. had delisted two patents on its branded drug, ZocorŪ (simvastatin), which the FDA interpreted as eliminating Ranbaxy's 180-day exclusivity on the 80 mg strength of Simvastatin tablets. Ranbaxy challenged this decision on the basis that it was inconsistent with the Hatch- Waxman Act. The Generic Pharmaceutical Association (GPhA) filed an amicus brief supporting Ranbaxy's position. The District Court agreed, and Ranbaxy launched 80 mg Simvastatin tablets with 180-day exclusivity in June 2006. Ranbaxy currently has over 60 percent market share for the 80 mg strength of Simvastatin tablets.

Commenting on the decision, Jay Deshmukh, Senior Vice President -- Global Intellectual Property, Ranbaxy, noted, "We are pleased with this decision, for both Ranbaxy and the generic pharmaceutical industry, as it preserves the exclusivity of innovative generic pharmaceutical companies who expend significant effort and finances to introduce affordable generic medicines to the U.S. healthcare system."

Ranbaxy Laboratories Limited, headquartered 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 8 countries.

ZocorŪ is a registered trademark of Merck & Co., Inc.

Source: Ranbaxy Laboratories

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