AstraZeneca enters into a settlement agreement with Accord Healthcare, Inc. and Intas Pharmaceuticals Ltd regarding US SEROQUEL XR® patent litigation

AstraZeneca today announced it has entered into a settlement agreement in its US SEROQUEL XR® patent infringement litigation against Accord Healthcare, Inc. (Accord) and Intas Pharmaceuticals Ltd (Intas) regarding Accord’s proposed generic version of AstraZeneca’s SEROQUEL XR (quetiapine fumarate) extended-release tablets.

The agreement settles the patent infringement litigation filed by AstraZeneca following Accord’s submission to the US Food and Drug Administration of an Abbreviated New Drug Application (ANDA) for a generic version of SEROQUEL XR. Under the settlement agreement, Accord does not dispute that the patent asserted by AstraZeneca in the US patent litigation is valid and enforceable.

As part of the agreement, AstraZeneca has granted Accord a licence to enter the US market with generic SEROQUEL XR on 1 November 2016 or earlier upon certain circumstances. SEROQUEL XR is protected by patents and other exclusivity rights that range from March 2012 to November 2017.

AstraZeneca and Accord will file a proposed Consent Judgment with the US District Court for the District of New Jersey requesting the Court dismiss the pending legal action between AstraZeneca and Accord. The remaining SEROQUEL XR patent infringement litigations remain on-going.

The settlement with Accord will have no impact on the Company’s full year 2011 financial guidance. As is customary, the Company will review its financial guidance in conjunction with its Third quarter and Nine Months 2011 Financial Results announcement on 27 October.