; or (ii) increases the average manufacturer price for the applicable drug above the fair price (increased by the consumer price index for all urban consumers (as published by the Bureau of Labor Statistics) for that year), the Secretary shall revoke the purchaser’s approved application and resume production of the applicable drug. (d) Insulin Not later than 1 year after the date of enactment of this section, the Secretary shall begin the public manufacturing of insulin meeting the definition of applicable drug and in accordance with this section. (e) Applicable drug In this section, the term applicable drug means a drug (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act), biological product (as defined in section 351 of the Public Health Service Act), or combination product (as described in section 503(g) of the Federal Food, Drug, and Cosmetic Act) for which an approved application under section 505 or 515 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act, or clearance under section 510(k) of the Federal Food, Drug, and Cosmetic Act, is in effect, and— (1) (A) for which, with respect to a drug included in the list described in section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act, each patent included with respect to such drug in such list has expired, or each patent that claims a biological product has expired; (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