AstraZeneca Enters into a Settlement Agreement with Handa
Pharmaceuticals regarding US SEROQUEL XR® Patent Litigation
For immediate release: 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.
- ENDS -
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.
About AstraZeneca
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. AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. For more
information please visit:
www.astrazeneca.com (http://www.astrazeneca.com/)
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AstraZeneca Enters into a Settlement Agreement with Handa Pharmaceuticals regarding US SEROQUEL XR® Patent Litigation
| Quelle: AstraZeneca PLC