New Delhi: Ranbaxy Pharmaceuticals Inc, a wholly-owned subsidiary of Ranbaxy Laboratories Ltd, has reached an agreement with pharma major AstraZeneca that would allow Ranbaxy to start exclusive sales of a generic version of ulcer drug Nexium in 2014 in the US.
Nexium is brand name used by AstraZeneca and is the second largest selling drug in the US. Ranbaxy would be able to start sales from May 27, 2014 under license from AstraZeneca. During the 180 period following that date, Ranbaxy will distribute the only generic esomeprazole magnesium product in the US market.
“We are happy with the agreement which will provide certainty as to the launch of a generic formulation of the second largest selling product in the US, Ranbaxy Laboratories CEO and Managing Director Malvinder M Singh told PTI.
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 esomeprazole magnesium’s generic version.
Under the settlement agreement, Ranbaxy conceded that all six patents asserted by AstraZeneca in the patent litigation are valid and enforceable.
In another pact signed by the two companies, Ranbaxy will formulate a significant portion of AstraZenecas US supply of Nexium from May 2010. Ranbaxy will also start supplying raw material for manufacture of Esomeprazole magnesium to Astrazeneca from 2009.
“The revenues will flow in for Ranbaxy every year from next year due to these agreements,” Singh said.
In two separate agreements, AstraZeneca has designated Ranbaxy as the US distributor for the authorised generic versions of hypertension drug Felodipine and acid-related diseases drug Omeprazole 40 mg.