1. Short title This Act may be cited as the Expanding Access to Low Cost Generic Drugs Act . 2. 180-Day exclusivity period amendments regarding first applicant status (a) Amendments to Federal Food, Drug, and Cosmetic Act (1) In general Section 505(j)(5)(B) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(5)(B) ) is amended— (A) in clause (iv)(II)— (i) by striking item (bb); and (ii) by redesignating items (cc) and (dd) as items (bb) and (cc), respectively; (B) by redesignating clause (v) as clause (ix); and (C) by inserting after clause (iv) the following: (v) First applicant defined As used in this subsection, the term first applicant means an applicant— (I) (aa) that, on the first day on which a substantially complete application containing a certification described in paragraph (2)(A)(vii)(IV) is submitted for approval of a drug, submits a substantially complete application that contains and lawfully maintains a certification described in paragraph (2)(A)(vii)(IV) for the drug; and (bb) that has not entered into a disqualifying agreement described under clause (vii)(II); or (II) (aa) for the drug that is not described in subclause (I) and that, with respect to the applicant and drug, each requirement described in clause (vi) is satisfied