AstraZeneca 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.

Seroquel XR, a once-daily, extended-release tablet formulation of quetiapine fumarate, is approved in the US in adults for (1) add-on treatment to an antidepressant for patients with major depressive disorder (MDD) who did not have an adequate response to antidepressant therapy; (2) acute depressive episodes in bipolar disorder; (3) acute manic or mixed episodes in bipolar disorder alone or with lithium or divalproex; (4) long-term treatment of bipolar disorder with lithium or divalproex; and (5) schizophrenia.

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease.