1. Short title This Act may be cited as the Expanding Access to Low-Cost Generics Act of 2023 . 2. 180-day exclusivity period (a) In general Section 505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(5)(B)(iv) ) is amended— (1) in subclause (I)— (A) by inserting and subclause (III) after subparagraph (D) ; and (B) by inserting before the period at the end the following: or an applicant whose application was approved pursuant to subclause (III). If an applicant described in subclause (III) is eligible for effective approval on the same day a tentatively approved first applicant who has requested final approval is determined by the Secretary to be eligible for effective approval by meeting all the approval requirements of this subsection, such applicant described in subclause (III) shall not receive effective approval until 180 days after the first applicant begins commercial marketing of the drug.