Keywords: USA, AstraZeneca, Teva, Nexium, Prilosec, Ranbaxy, Dr Reddy's

AstraZeneca settles with Teva over generic Nexium, so avoiding a court battle

Article | 8 January 2010

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Anglo-Swedish drug major AstraZeneca has entered into an agreement with Israel-based generics giant Teva Pharmaceutical Industries and its affiliates to settle patent litigation regarding Teva’s proposed generic version of the UK-based firm’s blockbuster gastrointestinal drug Nexium (esomeprazole) delayed-release capsules, which generated global sales of $3.7 billion in the nine months to September 2009.

As part of the settlement, AstraZeneca has granted Teva a license to enter the US market with its generic esomeprazole on May 27, 2014, subject to regulatory approval, or earlier in certain circumstances. Teva has conceded that all patents-at-issue in Teva’s US Nexium patent litigations are valid and enforceable. The Israeli firm has also conceded that six Nexium patents would be infringed by the manufacture or sale of its US generic esomeprazole.

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The agreement has halted a court case brought by Teva against AstraZeneca, which was due to start this month. The US District Court for the District of New Jersey will now enter a Consent Judgment and corresponding Nexium patent litigations will be dismissed.

Also agree accord on Prilosec

In a separate agreement, AstraZeneca and Teva have agreed to settle patent litigation related to Prilosec (omeprazole). Under this, Teva will make a one-time, undisclosed payment to AstraZeneca for past infringing sales. The terms of this agreement are not financially material to AstraZeneca. The two companies will jointly file a Stipulation of Dismissal with the US District Court for the Southern District of New York. 

Meantime, Merck Sharp & Dome (part of US drug giant Merck & Co), through KBI Inc and KBI-E, and under the terms of Merck's restructured partnership with AstraZeneca, announced in 1998, also entered into the settlement agreements.

In a similar move, AstraZeneca struck with India’s Ranbaxy Laboratories, the first to file with the US Food and Drug Administration for a generic version of omeprazole, in April 2008. Still outstanding is a patent dispute with another Indian firm, Dr Reddy’s Laboratories, which is the most likely outstanding challenger to the patent.