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On April 23 President Biden signed into law changes narrowing
the scope of eligibility for the non-patent “new chemical
entity” (NCE) 5-year exclusivity provisions of 21 U.S.C.
§301 et seq. The 5-year exclusivity comprises a 4-year data
exclusivity provision during which time a generic applicant cannot
rely on the drug application to establish either safety or efficacy
which is followed by a 1-year marketing exclusivity. The
exclusivity provision found in 21 U.S.C. § 355 (c)(3)(E)(ii)
prior to the amendment described the NCE as applying to a drug