NCE exclusivity is actually 8 years from the date of approval, 7.5 years of NCE exclusivity + 6 months of pediatric exclusivity,
"If an application submitted under [FDC Act § 505(b)] for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under [FDC Act § 505(b)], is approved after September 24, 1984, no [ANDA] may be submitted under [FDC Act § 505(j)] which refers to the drug for which the [FDC Act § 505(b)] application was submitted before the expiration of five years from the date of the approval of the application under [FDC Act § 505(b)], except that [an ANDA] may be submitted under [FDC Act § 505(j)] after the expiration of four years from the date of the approval of the [FDC Act § 505(b)] application if it contains a [Paragraph IV certification]. The approval of such [ANDA] shall be made effective in accordance with [FDC Act § 505(j)(5)(B)] except that, if an action for patent infringement is commenced during the one-year period beginning forty-eight months after the date of the approval of the [NCE NDA], the thirty-month period referred to in [FDC Act § 505(j)(5)(B)(iii)] shall be extended by such amount of time (if any) which is required for seven and one-half years to have elapsed from the date of approval of the [NCE NDA]."
HD: Three-year New Use/New Clinical Studies Exclusivity. New indications or dosage forms of previously approved drugs can receive new use or new clinical study exclusivity. The application must contain reports of new clinical investigations conducted by the applicant. The exclusivity term runs for three years from NDA approval and it bars the FDA from approving any ANDA or 505(b)(2) application by another party that relies on the same clinical studies. This exclusivity can be coupled with a six-month pediatric exclusivity.
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