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SEROQUEL ANDA
- Reference code :
- wf5164
- Published date :
-
28 September 2005
- Expired date :
-
13 February 2033
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
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