AstraZeneca announced it has entered into a settlement agreement in its US 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 US Food and Drug Administration (US FDA) 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 US patent litigation are valid and enforceable.
As part of the agreement, AstraZeneca has granted Handa 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 Handa will file a proposed Consent Judgement with the US 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.
On 13 December, 2010 Handa announced that its ANDA, seeking approval for generic copies of Seroquel XR, had received tentative approval from the US FDA. Handa further announced that they believed they are the first applicant to file for 50, 150, 200 and 300mg tablets and, that they will be entitled to 180 days of marketing exclusivity for these tablet strengths upon receipt of final regulatory approval.
Seroquel XR, a once-daily, extended-release tablet formulation of quetiapine fumarate, is approved in the US in adults for add-on treatment to an antidepressant for patients with major depressive disorder (MDD) who did not have an adequate response to antidepressant therapy; acute depressive episodes in bipolar disorder; acute manic or mixed episodes in bipolar disorder alone or with lithium or divalproex; long-term treatment of bipolar disorder with lithium or divalproex; and 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.