AstraZeneca settles US Nexium patent litigation with Ranbaxy
AstraZeneca has entered into a settlement agreement in its Nexium patent infringement litigation against Ranbaxy Laboratories Ltd and its affiliates.
AstraZeneca has entered into a settlement agreement in its Nexium patent infringement litigation against Ranbaxy Laboratories Ltd and its affiliates.
The agreement settles the patent infringement litigation filed by AstraZeneca following Ranbaxy's submission to the US 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 agreement will allow Ranbaxy to commence sales of a generic version of Nexium under a licence from AstraZeneca on 27 May 2014, the date that marks the expiry of US Patent Numbers 5,877,192 and 6,875,872. AstraZeneca's patents protecting Nexium have expiration dates that range from 2014 through 2019.
Merck & Co., through KBI Inc. and KBI-E and under the terms of Merck's restructured partnership with AstraZeneca announced in 1998, has also entered into the settlement agreement. However, AstraZeneca's Nexium patent infringement litigations against Teva/IVAX and Dr Reddy's Laboratories remain ongoing.
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.
The companies have also entered into two separate agreements designating Ranbaxy as the US distributor for authorised generic versions of Plendil (felodipine) and 40mg Prilosec (omeprazole). Ranbaxy will be compensated for its distribution services on standard commercial terms.