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AZ and Teva reach agreement over Entocort

AZ has reach an agreement with Teva Pharmaceuticals USA to settle patent litigation relating to Entocort EC

AstraZeneca (AZ) has entered into an agreement with generic drug maker, Teva Pharmaceuticals USA (Teva), to settle patent litigation regarding Teva's proposed generic version of AZ's Entocort EC (budesonide) capsules, which lose patent protection as a treatment for adults with Crohn's disease in July 2014, and as a treatment for children in January 2015.

The terms of the settlement agreement give Teva a licence to enter the US market with its generic version of oral budesonide in February 2012, subject to regulatory approval, or earlier in certain circumstances. Teva has conceded that both patents-in-suit in Teva's US Entocort patent litigation are valid and enforceable, and that both Entocort patents-in-suit would be infringed by the manufacture or sale of Teva's generic version of oral budesonide.

The US District Court for the District of Delaware will enter a Consent Judgment and the corresponding patent litigation will be dismissed. Further terms of the settlement remain confidential.

19th May 2010


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