Pressmeddelande -
SEROQUEL ANDA
AstraZeneca received a notice from Teva Pharmaceuticals USA on September 27, 2005, that Teva has submitted an Abbreviated New Drug Application (ANDA) for quetiapine fumarate tablets (25mg base) containing a Paragraph IV Certification (alleging invalidity and non-infringement) with respect to AstraZenecas US patent number 4,879,288. AstraZenecas US patent number 4,879,288 is listed in the Orange Book in reference to Seroquel.
AstraZeneca is evaluating Tevas notice, and the company continues to have full confidence in its intellectual property protecting Seroquel.
AstraZeneca has 45 days within which to commence a patent infringement lawsuit against the filer of an ANDA that would automatically stay, or bar, the FDA from approving the ANDA for 30 months (or until an adverse court decision, whatever may occur earlier).
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