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Ranbaxy and AstraZeneca Reach Agreement in Esomeprazole Patent Litigation
Date:4/15/2008

Companies Also Sign Manufacturing and Distribution Agreement

GURGAON, India and PRINCETON, N.J., April 15 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that it has reached several agreements with AstraZeneca. Two of these agreements concern Esomeprazole magnesium capsules. The third agreement pertains to Omeprazole 40mg tablets, and the fourth agreement pertains to Felodipine ER capsules. All of the agreements are specific to the U.S. market.

The agreement settles the patent infringement litigation filed by AstraZeneca following Ranbaxy's submission to the United States Food & Drug Administration of an Abbreviated New Drug Application for a generic version of Esomeprazole magnesium. Under the settlement agreement, Ranbaxy concedes that all six patents asserted by AstraZeneca in the patent litigation are valid and enforceable.

The settlement agreement will allow Ranbaxy to commence exclusive sales of a generic version of Nexium under a license from AstraZeneca on May 27, 2014. During the 180-day period following the date, RPI will distribute the only generic Esomeprazole magnesium product in the US market.

Ranbaxy has filed a Consent Judgment with the U.S. District Court for the District of New Jersey reflecting the terms of the settlement agreement. With the Court now having entered the Consent Judgment, the settlement agreement is final, and the patent infringement litigation against Ranbaxy has been dismissed.

Merck & Co., Inc., through KBI Inc. and KBI-E and under the terms of Merck's restructured partnership with AstraZeneca announced in 1998, has also entered into the settlement agreement.

"We are pleased with the agreement which will provide certainty as to the launch of a generic formulation of Esomeprazole magnesium in the US market," according to Malvinder M. Singh, CEO and Managing Director of Ranbaxy Laboratories Ltd.
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SOURCE Ranbaxy Pharmaceuticals Inc.
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