Delisting counterclaims, even if successful, are typically not resolved quickly enough to provide significant benefit to the generic applicants impacted by the listing.
Because the Act requires that applicants seeking to market a generic version of a given drug product must address each of the listed patents as part of their application.
A paragraph IV certification kicks off a statutorily-prescribed process whereby the generic applicant provides the NDA holder with notice of the certification, after which time the NDA holder has 45 days to bring a lawsuit.
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