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4 (6) doi: 10.1128/microbiolspec.TNMI7-0023-2016 25 SaingT.LagmanM.CastrillonJ.GutierrezE.GuilfordF

The 180-Day Generic Exclusivity Incentive: First-Filer Economics The first ANDA applicant to file a substantially complete Paragraph IV challenge against a given Orange Book patent earns 180 days of generic exclusivity