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). Media Enquiries: Staffan Ternby, 08-553 261 07 Edel McCaffrey, +44 (0) 207 304 5034 Steve Brown, +44 (0) 207 304 5033 Investor Enquiries: Staffan Ternby, 08-553 261 07 Mina Blair, +44 (0) 207 304 5084 Jonathan Hunt, +44 (0) 207 304 5087

About Us

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009. For more information please visit: www.astrazeneca.com

Subscribe