; (B) any period of regulatory exclusivity granted under— (i) clause (ii), (iii), or (iv) of section 505(c)(3)(E) of the Federal Food, Drug, and Cosmetic Act, 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, and any extension of such a period granted under section 505A or 505E of such Act, has expired; or (ii) paragraph (6) or (7) of section 351(k) of the Public Health Service Act, and any extension of such a period granted under paragraph (2) or (3) of section 351(m) of such Act, has expired; and (C) (i) that is not being marketed in the United States; or (ii) that is being marketed in the United States by 3 or fewer manufacturers with an approved abbreviated new drug application or biosimilar (not including manufacturers of authorized generics under a new drug application or biosimilar), and that— (I) in the previous 5-year period, has experienced an increase in the wholesale acquisition cost by at least 1 of its manufacturers that is greater than the consumer price index for all urban consumers (as published by the Bureau of Labor Statistics) for 1 of the years in that the same period; (II) is included in the drug shortage list under section 506E of the Federal Food, Drug, and Cosmetic Act; or (III) (aa) has an average wholesale acquisition cost that the Office determines to be a barrier to patient access; and (bb) is listed by the World Health Organization as an essential medicine; or (2) for which there is in effect a license, or patent use is authorized, under— (A) section 1498 of title 28, United States Code; (B) section 202 of title 35, United States Code; (C) section 203 of title 35, United States Code (march-in rights); (D) section 209 of title 35, United States Code; or (E) any other licensing authority of the Federal Government. (k) Authorization of appropriations There are authorized to be appropriated such sums as may be necessary to carry out this section. .