AstraZeneca Reaches US Agreement With Teva Pharmaceuticals Regarding Entocort EC Capsules

Tuesday, 18 May 2010

AstraZeneca today announced that it has entered into an agreement with Teva Pharmaceuticals USA, Inc. (formerly Barr Laboratories, Inc.) (“Teva”) to settle patent litigation regarding Teva’s proposed generic version of AstraZeneca’s Entocort EC (budesonide) capsules.

Under the terms of the settlement agreement, AstraZeneca has granted Teva a license to enter the US market with its generic version of oral budesonide on 15 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. Teva has also conceded 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. Other terms of the settlement are confidential.

Merck Sharp & Dohme Corp. (formerly Merck & Co., Inc.) (“Merck”), 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 agreement.


About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009. For more information please visit:


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