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Generic Applications With Paragraph IV Filings, In Brief

Executive Summary

Barr challenges Eloxatin patent: Barr Pharmaceuticals has filed an ANDA with a Paragraph IV certification - by which an ANDA sponsor contends that a patent is invalid, unenforceable, or will not be infringed by the generic - for Sanofi-Aventis' Eloxatin (oxaliplatin). There are currently no generic versions of the drug, and Sanofi filed suit Jan. 4 to initiate patent litigation. There are four patents listed in FDA's Orange Book for 5mg/mL Eloxatin, the last of which expires in Feb. 2016. The colorectal cancer agent is covered by pediatric exclusivity until Feb. 9, 2008...
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PS049233

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