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Mumbai, Apr 15: Ranbaxy Pharmaceuticals Inc (RPI), a wholly-owned subsidiary of Ranbaxy Laboratories, has reached a settlement agreement with AstraZeneca on the US sales of the blockbuster drug, Nexium. A patent infringement litigation had been filed by AstraZeneca following Ranbaxy’s submission of an abbreviated new drug application (ANDA) for a generic version of esomeprazole magnesium (Nexium). Recently, Ranbaxy had entered into similar out-of-court deals with US-based majors for selling generic versions of top selling drugs in the US.
Apart from the settlement, the companies have also entered into two separate agreements designating Ranbaxy as the American distributor for the authorised generic versions of Felodipine capsules and Omeprazole 40-mg tablets. Ranbaxy will be compensated for its distribution services on standard commercial terms. “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,” said Malvinder M Singh, CEO and managing director of Ranbaxy Laboratories Ltd. The settlement agreement will allow Ranbaxy to commence exclusive sales of a generic version of Nexium under a licence from AstraZeneca on May 27, 2014. During the 180-period following the date, RPI will distribute the only generic esomeprazole magnesium product in the US market, stated a company release.
Ranbaxy will formulate a significant portion of AstraZeneca’s US supply of Nexium from May 2010, including provisions for the manufacture of esomeprazole magnesium, the active pharmaceutical ingredient (API) from May 2009. In January 2008, Ranbaxy Laboratories had entered into a similar settlement agreement with GlaxoSmithKline (GSK) over the $985-million migraine drug, Imitrex, allowing it to sell in the US from December ’08. In November ’07, Ranbaxy had reached an agreement with Astellas/Boehringer Ingelheim regarding Flomax (tamsulosin capsules), which will allow Ranbaxy to market the drug in the US by March ’10. In July ’07, it declared a contract with GSK for Valtrex anticipating 180-day market exclusivity during the second half of 2009.
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