; and (3) 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. (b) Definitions For purposes of this section: (1) Covered opioid 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 subsection (h)(2) of section 303 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 333 ), has generated at least $1. (2) Period of market exclusivity 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, or section 351(k)(7) of the Public Health Service Act ( 42 U.S.C. 262(k)(7) ), 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). (3) Product hopping 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— (A) is intended for the treatment of the same medical condition as the drug or biological product that was originally so approved