Sec. 3. Reduced exclusivity
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/bill/116/s/1584/is/section-3A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
If a drug manufacturer violates section 2(b) with respect to a covered opioid, effective on the date on which such manufacturer is found to have so violated such section— any remaining period of market exclusivity with respect to such covered opioid shall be revoked; the period of market exclusivity with respect to any other opioid for which such manufacturer is the holder of an approved application under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or a license under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) shall be reduced to one-half of the remaining period of market exclusivity; and no new or additional exclusivity shall be awarded to any opioid for which an application is submitted by such manufacturer for approval under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) or marketed as a result of product hopping.
For purposes of this section: A covered opioid is a prescription opioid drug, the sales of which in the United States, beginning on the date on which the drug was first eligible to be marketed in the United States and ending on the date on which the manufacturer was found to be in violation of section 2(b), has generated at least $1. The term period of market exclusivity with respect to a drug means the total period of market exclusivity granted under clause (ii), (iii), or
(iv)of section 505(c)(3)(E) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c)(3)(E) ), section 505(j)(5)(B)(iv) of such Act, clause (ii), (iii), or
(iv)of section 505(j)(5)(F) of such Act, section 527 of such Act ( 21 U.S.C. 360cc ), or paragraph
(6)or
(7)of section 351(k) of the Public Health Service Act ( 42 U.S.C. 262(k) ), and any extension of such a period granted under section 505A or 505E of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355a , 355f). The term product hopping means a reformulation of an approved drug or biological product that allows a manufacturer to submit a new drug application under section 505(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b) ) or new application for a license under section 351(a) of the Public Health Service Act ( 42 U.S.C. 262(a) ) and that— is intended for the treatment of the same medical condition as the drug or biological product that was originally so approved; and is undertaken in conjunction with the sponsor's actions to reduce or eliminate demand for the original formulation of the drug or biological product.
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