Our partner Par has already latched on to that exclusivity period. Interestingly enough they were one of the litigants that lost the U.S. court deceision challenging AstraZeneca's patent rights. So it appears they were covering the flip side against that lost. At least we can rule them out as our U.S. partner and perhaps strengthen our bid with Teva on that front.
I believe this is what the company was referring to in their press release.
Handa Pharmaceuticals Announces Acquisition and License Agreement with Par Pharmaceutical for Its First-to-File ANDA for AstraZeneca’s SEROQUEL XR®
October 29, 2012
Handa Pharmaceuticals, LLC ("Handa"), a specialty pharmaceutical company based in Fremont, California, today announced that it has entered into an exclusive acquisition and license agreement with Par Pharmaceutical, Inc. for Handa's Abbreviated New Drug Application ("ANDA") for quetiapine fumarate extended-release tablets, the generic version of AstraZeneca’s SEROQUEL XR®. Handa believes it is the first applicant to file an ANDA containing a paragraph IV certification for the 50 mg, 150 mg, 200 mg and 300 mg strengths of the product, which would potentially provide 180 days of marketing exclusivity. According to IMS Health data, annual U.S. sales for these strengths of Seroquel XR® are approximately $808 million. The ANDA also includes the 400 mg dosage strength.
Under the terms of the agreement, Handa has received a payment from Par for the ANDA, giving Par the exclusive rights to market, sell and distribute quetiapine fumarate extended-release tablets in the U.S. under the ANDA, subject to its final approval by the U.S. Food and Drug Administration. Handa will receive a percentage of profits from the sales of the product. Under the terms of a settlement agreement with AstraZeneca, Par has been assigned a license to enter the U.S. market with quetiapine fumarate extended-release tablets on November 1, 2016 or earlier under certain circumstances.
Also there were other settlements. Notice all were given the same start date or sooner disclosure.
I think I remember 1 of Shameze presentation suggesting this, that the ones who settled (recognizing their patents) got the earlier potential release dates prior to patent expiration.
AstraZeneca enters into a settlement agreement with Accord Healthcare, Inc. and Intas Pharmaceuticals Ltd regarding US SEROQUEL XR® patent litigation
Wednesday, 5 October 2011
AstraZeneca today announced it 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.
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