AstraZeneca PLC
28 September 2005
Stock Exchange Announcement
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 AstraZeneca's US
patent number 4,879,288. AstraZeneca's US patent number 4,879,288 is listed in
the Orange Book in reference to Seroquel.
AstraZeneca is evaluating Teva's 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).
-Ends-
September 28, 2005
Media Enquiries:
Edel McCaffrey, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033
Investor Enquiries:
Mina Blair, Tel: +44 (0) 207 304 5084
Jonathan Hunt, Tel: +44 (0) 207 304 5087
Ed Seage, Tel: +1 302 886 4065
Jorgen Winroth, Tel + 1 212 579 0506
This information is provided by RNS
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