AstraZeneca, Ranbaxy Reach
Settlement in Drug Patent Case
By DANIEL THOMAS
April 15, 2008 5:32 a.m.
LONDON -- Pharmaceutical firm AstraZeneca PLC Tuesday said that it has entered into a settlement agreement with generics maker Ranbaxy Laboratories Ltd. to end a lawsuit over patent infringements for its Nexium heartburn drug.
AstraZeneca said the pact settles a patent infringement suit it had filed against the Indian company, which had submitted an application to the U.S. Food and Drug Administration to make a generic version of the drug. AstraZeneca faced a risk to sales from generic drug maker Ranbaxy selling copies of Nexium in the U.S. A spokesman for Ranbaxy couldn't be reached for comment immediately.
Ranbaxy would have been free to start selling a generic version of Nexium in the U.S. after April 14, when a 30-month stay barring it from the market expired. London-based AstraZeneca is the world's sixth-largest drug company by sales. U.S. sales of Nexium and Seroquel, a schizophrenia drug, made up about 21% of AstraZeneca's total sales of $29.56 billion last year.
The settlement means that Ranbaxy will be able to begin selling a generic version of Nexium from May 27, 2014. "Under the settlement agreement, Ranbaxy concedes that all six patents asserted by AstraZeneca in the patent litigation are valid and enforceable," said AstraZeneca in a statement. "Ranbaxy also accepts that four of the patents would be infringed by the unlicensed sale of Ranbaxy's proposed generic product."
Merck & Co., Inc., through KBI Inc. and KBI-E, has also entered into the settlement agreement, AstraZeneca said.
AstraZeneca and Ranbaxy have also entered into two separate agreements, in which Ranbaxy becomes the U.S. distributor for authorized generic versions of Plendil (felodipine) and 40mg Prilosec (omeprazole).
Ranbaxy will be compensated for its distribution services, said AstraZeneca.
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