; and (B) annually for the duration of the 7-year period described in subsection (a) with respect to the drug, that there continues to be no reasonable expectation that the cost of developing and making available in the United States such drug for such disease or condition will be recovered from sales in the United States of such drug, taking into account all sales made or reasonably expected to be made without a time limitation. (2) Considerations For purposes of subparagraphs (A) and (B) of paragraph (1), the Secretary and the sponsor of the application for the drug designated for a rare disease or condition described in such paragraph shall consider sales from all drugs for such disease or condition that— (A) are developed or marketed by the same sponsor or manufacturer of the drug (or a licensor, predecessor in interest, or other related entity to the sponsor or manufacturer); and (B) contain the same active moiety as the drug, regardless of whether or not the drugs also contain different or additional active moieties. (3) Criteria No drug designated under section 526 for a rare disease or condition pursuant to the criteria set forth in subsection (a)(2)(B) of such section shall be eligible for exclusive approval or licensure under this section unless it met such criteria under such subsection on the date on which the drug was approved or licensed. . (b) Rule of construction The amendments made in subsection (a) shall apply to any drug that has been or is hereafter designated under section 526 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bb ) for a rare disease or condition pursuant to the criteria under subsection (a)(2)(B) of such section regardless of— (1) the date on which such drug is designated or becomes the subject of a designation request under such section