18th Oct 2005 07:01
AstraZeneca PLC18 October 2005 NEXIUM ANDA AstraZeneca has received a notice from Ranbaxy Pharmaceuticals Inc. that RanbaxyLaboratories Limited has submitted an Abbreviated New Drug Application (ANDA)for esomeprazole magnesium delayed-release capsules, 20mg and 40mg, containingParagraph IV Certifications of invalidity and/or non-infringement with respectto certain AstraZeneca US patents listed in the Orange Book in reference toNexium, the latter of which expires in 2018. AstraZeneca has 45 days within which to commence a patent infringement lawsuitagainst Ranbaxy that would automatically stay, or bar, the FDA from approvingRanbaxy's ANDA for 30 months or until an adverse court decision, whichever mayoccur earlier. Ranbaxy has also certified with respect to certain other AstraZeneca US patentslisted in the Orange Book in reference to Nexium that Ranbaxy will not launchits product prior to the expiry of those patents, the latter of which expires inOctober 2007. AstraZeneca is evaluating Ranbaxy's notice and continues to have full confidencein its intellectual property protecting Nexium. -Ends- 18 October 2005 Media Enquiries:Edel McCaffrey, Tel: +44 (0)20 7304 5034Steve Brown, Tel: +44 (0)20 7304 5033 Investor Enquiries:Mina Blair, Tel: +44 (0)20 7304 5084Jonathan Hunt, Tel: +44 (0)20 7304 5087Ed Seage, Tel: +1 302 886 4065Jorgen Winroth, Tel + 1 212 579 0506 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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