Mumbai: Ranbaxy Pharmaceuticals Inc, a wholly-owned subsidiary of Ranbaxy Laboratories Ltd, has reached a patent litigation settlement with AstraZeneca Plc over ulcer pill Nexium, that would allow Ranbaxy to start exclusive sales of a generic version of ulcer drug Nexium in 2014 in the US.
Ranbaxy Laboratories, India's top drugmaker by sales, said the settlement with AstraZeneca Plc would reflect in its revenue from 2009.
Under the deal, Ranbaxy would be allowed to start selling a cheap version of Nexium on May 27, 2014, after the expiry of the earliest patents on the drug. But the agreement allows Ranbaxy to formulate a portion of AstraZeneca's US supply of Nexium from May 2010, with the active ingredient in the drug, esomeprazole magnesium, being made from May 2009.
Nexium is Astrazeneca's second largest selling drug in the US. The agreement settles the patent infringement litigation filed by AstraZeneca after Ranbaxy submitted an abbreviated new drug application (ANDA) for esomeprazole magnesium's generic version to the US Food & Drug Administration.
"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, Malvinder Mohan Singh, CEO and managing director of Ranbaxy Laboratories, said.
''So, 2014 will be a very significant opportunity for us, plus at the same point in time, we would also start supplying APIs to AstraZeneca for Nexium starting next year followed by supplying dosage forms to AstraZeneca in 2010,'' CNBC quoted Mohan Singh as saying in an interview.
Ranbaxy conceded that all six patents asserted by AstraZeneca in the patent litigation are valid and enforceable.
A Ranbaxy statement said it also had two other agreements with AstraZeneca for Omeprazole 40mg, an ulcer pill, and heart drug Felodipine ER.
"We have also got an authorised generic for Omeprazole 40mg and Felodipine ER, which both put together is a $450 million market," Singh said.
Singh also said he was planning to launch an initial public offer for SRL Ranbaxy, which operates a chain of pathology laboratories, by the end of 2008 or some time in 2009. SRL Ranbaxy is owned by the founders of Ranbaxy.