Clauses (ii) through (v) of section 505(c)(3)(E) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c)(3)(E) ). (B) Section 505(j)(5)(B)(iv) of such Act ( 21 U.S.C. 355(j)(5)(B)(iv) ) or clause (ii), (iii), or (iv) of section 505(j)(5)(F) of such Act. (C) Section 505A of such Act ( 21 U.S.C. 355a ). (D) Section 505E of such Act ( 21 U.S.C. 355f ). (E) Section 527 of such Act ( 21 U.S.C. 360cc ). (F) Section 351(k)(7) of such Act ( 42 U.S.C. 262(k)(7) ). (G) Any other provision of law that provides for exclusivity (or extension of exclusivity) with respect to a drug. (4) Listed drug The term listed drug means a drug listed under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(7) ). (5) Manufacturer The term manufacturer , with respect to a prescription drug, means an entity that— (A) is the holder of the approved application 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 )