Nexium ANDA

AstraZeneca PLC 18 October 2005 NEXIUM ANDA AstraZeneca has received a notice from Ranbaxy Pharmaceuticals Inc. that Ranbaxy Laboratories Limited has submitted an Abbreviated New Drug Application (ANDA) for esomeprazole magnesium delayed-release capsules, 20mg and 40mg, containing Paragraph IV Certifications of invalidity and/or non-infringement with respect to certain AstraZeneca US patents listed in the Orange Book in reference to Nexium, the latter of which expires in 2018. AstraZeneca has 45 days within which to commence a patent infringement lawsuit against Ranbaxy that would automatically stay, or bar, the FDA from approving Ranbaxy's ANDA for 30 months or until an adverse court decision, whichever may occur earlier. Ranbaxy has also certified with respect to certain other AstraZeneca US patents listed in the Orange Book in reference to Nexium that Ranbaxy will not launch its product prior to the expiry of those patents, the latter of which expires in October 2007. AstraZeneca is evaluating Ranbaxy's notice and continues to have full confidence in its intellectual property protecting Nexium. -Ends- 18 October 2005 Media Enquiries: Edel McCaffrey, Tel: +44 (0)20 7304 5034 Steve Brown, Tel: +44 (0)20 7304 5033 Investor Enquiries: Mina Blair, Tel: +44 (0)20 7304 5084 Jonathan Hunt, Tel: +44 (0)20 7304 5087 Ed Seage, Tel: +1 302 886 4065 Jorgen Winroth, Tel + 1 212 579 0506 This information is provided by RNS The company news service from the London Stock Exchange

Companies

AstraZeneca (AZN)
UK 100

Latest directors dealings