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Pfizer Norvasc Patent: Will Court Limit Extension To “Approved” Product?

Executive Summary

Dr. Reddy's reliance on Norvasc data in its 505(b)(2) application for amlodipine maleate could impact an appeals court's determination of whether Pfizer's patent term extension applies only to the approved besylate salt form of the drug

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Pfizer Norvasc Patent Term Extension Keeps AmVaz Off The Market Until 2007

Pfizer's Norvasc (amlodipine besylate) will not face competition from Dr. Reddy's calcium channel blocker AmVaz until 2007 under a federal appeals court ruling

Pfizer Norvasc Patent Term Extension Keeps AmVaz Off The Market Until 2007

Pfizer's Norvasc (amlodipine besylate) will not face competition from Dr. Reddy's calcium channel blocker AmVaz until 2007 under a federal appeals court ruling

Dr. Reddy’s AmVaz Approval Stayed; FDA Reconsiders Norvasc Competitor

FDA's stay of Dr. Reddy's AmVaz suggests the agency is taking another look at the amlodipine maleate NDA to bolster its response to Pfizer's scientific argument against use of the 505(b)(2) approval pathway

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