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Generic esomeprazole possible in Canada

The Federal Court of Canada will allow Apotex to submit a regulatory application for generic Nexium (esomeprazole; AZ) ahead of patent expiry

The Federal Court of Canada has dismissed AstraZeneca's (AZ) request to prohibit the Canadian Minister of Health from issuing a Notice of Compliance (NOC) for the regulatory applications for generic esomeprazole magnesium submitted by Apotex. The drug is marketed as Nexium by AZ.

As a result, the Canadian Minister of Health is now free to issue an NOC to Apotex, if their regulatory submissions are in an approvable form, prior to the expiration of Nexium's Canadian patents, which will occur between 2013 and 2019.

In a Canadian proceeding seeking prohibition of an NOC, a presiding court does not rule on the validity of patents, and this decision has no bearing on cases in other jurisdictions.

AZ is reviewing the ruling, which relates to only one of Nexium's Canadian patents, and is evaluating its options. These include initiating a comprehensive patent infringement action. The company has stated that it will continue vigorously to defend its intellectual property for Nexium.

Nexium has faced many patent challenges since its launch in 2001, as did the first-generation drug Prilosec (omeprazole).

17th June 2010

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