Generic Seroquel XR®

Another product candidate in our generics pipeline is quetiapine fumarate extended-release capsules. It is a generic version of the marketed drug Seroquel XR®  sold in the United States by Astra Zeneca Pharmaceuticals LP ("AstraZeneca"). In October 2016 our ANDA for this product received tentative approval from the U.S. Food and Drug Administration ("FDA") in the 50, 150, 200, 300 and 400 mg strengths.  In October 2016, the Company also announced it had entered into a license and commercial supply agreement with Mallinckrodt LLC ("Mallinckrodt"), by which the Company has granted Mallinckrodt an exclusive license to market, sell and distribute in the United States its ANDA for generic Seroquel XR® under a 10 year agreement.
Pursuant to a settlement agreement between the Company and AstraZeneca dated July 30, 2012, the Company is permitted to launch its generic versions of the 50, 150, 200, 300 and 400 mg strengths of generic Seroquel XR®, on November 1, 2016, subject to FDA final approval of the Company's ANDA for those strengths. Such FDA final approval is subject to a 180 day exclusivity period relating to a prior filer or filers of a generic equivalent of the branded product.  The company believes that in early November 2016, Par launched the 50, 100, 200, and 300 mg strengths, and Accord launched the 400 mg strength. The Company and its marketing and distribution partner for generic Seroquel XR® in the U.S., Mallinckrodt, are working diligently towards a launch of all such strengths upon their respective final FDA approvals Our intent is to launch these strengths after FDA final approval following expiry of the other companies' exclusivity period.
Quetiapine fumarate is an oral psychotropic agent indicated for the treatment of schizophrenia, bipolar disorder, and major depressive disorder. According to Symphony Health Solutions, sales of Seroquel XR® were approximately US$1.1 billion for the 12 months ending January 2017 (TRx MBS Dollars).

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