"AstraZeneca announced that it settled US patent litigation surrounding Seroquel XR (quetiapine), allowing Handa Pharmaceuticals to launch a generic version of the antipsychotic on November 1, 2016, or earlier upon certain circumstances. No financial terms of the deal were disclosed. "We believe this agreement reaffirms our intellectual property rights and is the right business decision for AstraZeneca at this time," commented CEO David Brennan.
Under the deal, the pending legal action between the two companies, which was filed by AstraZeneca after Handa sought approval for a generic version of Seroquel XR, will be dismissed. Handa has agreed that "both patents asserted by AstraZeneca…are valid and enforceable," and in return, the UK drugmaker granted the company a licence to enter the US market with generic Seroquel XR. AstraZeneca noted that the product "is protected by patents and other exclusivity rights that range from March 2012 to November 2017."
Handa's chief operating officer Stephen Cary said that the settlement resolves a case that was scheduled to go to trial on October 3. AstraZeneca indicated that the remaining patent infringement litigation regarding Seroquel XR is ongoing, with the trial in federal court in Trenton, New Jersey expected to go ahead as planned. Panmure analyst Savvas Neophytou remarked that although there are a number of other challenges remaining, "Handa's formulation was the most dangerous in our view, as it contained the least amount of overlap with AstraZeneca's patents."
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Seroquel XR, 750 $million a year in sales for AstraZeneca
AstraZeneca press release 9-30-11
"AstraZeneca enters into a settlement agreement with Handa Pharmaceuticals regarding US SEROQUEL XR® patent litigation
Thursday, 29 September 2011
AstraZeneca today 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 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 Judgment 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.
NOTES TO EDITORS
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.
About SEROQUEL XR
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."
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