The agreement settles the patent infringement litigation filed by AstraZeneca following Ranbaxy’s submission to the FDA of an abbreviated new drug application for a generic version of Nexium. Under the settlement agreement, Ranbaxy concedes that all six patents asserted by AstraZeneca in the patent litigation are valid and enforceable. Ranbaxy also accepts that four of the patents would be infringed by the unlicensed sale of Ranbaxy’s proposed generic product.
The settlement agreement will allow Ranbaxy to commence sales of a generic version of Nexium under a license from AstraZeneca on 27 May 2014. AstraZeneca’s patents protecting Nexium have expiration dates that range from 2014 through 2019.
AstraZeneca and Ranbaxy have filed a consent judgment with the US District Court of New Jersey reflecting the terms of the settlement agreement. With the Court now having entered the consent judgment, the settlement agreement is final, and the patent infringement litigation against Ranbaxy has been dismissed.
AstraZeneca and Ranbaxy have separately entered into agreements under which Ranbaxy will formulate a portion of AstraZeneca’s US supply of Nexium from May 2010, including provisions for the manufacture of esomeprazole magnesium, the active pharmaceutical ingredient in Nexium, from May 2009.
AstraZeneca and Ranbaxy have also entered into two separate agreements designating Ranbaxy as the US distributor for authorized generic versions of Plendil (felodipine) and 40mg Prilosec (omeprazole). Ranbaxy will be compensated for its distribution services on standard commercial terms.