AstraZeneca (NYSE: AZN) today announced it has entered into a settlement agreement in its U.S. SEROQUEL XR® patent infringement litigation against Handa Pharmaceuticals, LLC ("Handa") regarding Handa'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 Handa's submission to the U.S. Food and Drug Administration of an Abbreviated New Drug Application (ANDA) for a generic version of SEROQUEL XR. Under the settlement agreement, Handa does not dispute that both patents asserted by AstraZeneca in the U.S. patent litigation are valid and enforceable.
As part of the agreement, AstraZeneca has granted Handa a license to enter the U.S. 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 Handa will file a proposed Consent Judgment with the U.S. District Court for the District of New Jersey requesting the Court dismiss the pending legal action between AstraZeneca and Handa. The remaining SEROQUEL XR patent infringement litigations remain on-going.
"We believe this agreement reaffirms our intellectual property rights and is the right business decision for AstraZeneca at this time. SEROQUEL XR remains an important part of our company's portfolio benefiting patients and physicians throughout the world," said David Brennan, CEO of AstraZeneca.
This settlement 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.