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New Delhi, April 15: Pharmaceutical firm Ranbaxy Laboratories has settled a patent litigation with AstraZeneca Plc, an Anglo-Swedish company, over ulcer pill Nexium.
Ranbaxy said this would allow it to launch the generic version of the drug in the US by 2014. Ranbaxy has also entered into a manufacturing agreement for AstraZenecas US supply of Nexium from 2010 and a distribution agreement with the company for hypertension drug Felodipine and acidity drug Omeprazole. Nexium, a branded product of AstraZeneca, is the second largest selling drug in the US.
The agreement settles the patent infringement litigation filed by AstraZeneca following Ranbaxys submission to the United States Food and Drug Administration (USFDA) of an abbreviated new drug application for the generic version of esomeprazole magnesium.
According to the agreement, Ranbaxy will start selling the generic version from May 27, 2014 under a licence from AstraZeneca and during the 180 day marketing period, it will distribute only the generic esomeprazole magnesium product in the US market.The agreement will provide certainty to the launch of a generic formulation of the second largest selling product in the US, said Ranbaxy CEO Malvinder Mohan Singh.
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