Expanding Access to Low-Cost Generics Act of 2021

To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period, and for other purposes. 1. Short title This Act may be cited as the Expanding Access to Low-Cost Generics Act of 2021 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) (1) in subclause (I), 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 may not receive effective approval until 180 days after the first applicant begins commercial marketing of the drug. (2) by adding at the end the following new subclause: (III) Applicant approval The Secretary may approve an application containing a certification described in paragraph (2)(A)(vii)(IV) that is for a drug for which a first applicant has submitted an application containing such a certification, notwithstanding the eligibility of a first applicant for the 180-day exclusivity period described in subclause (II)(aa), if each of the following conditions is met: (aa) The approval of such application could be made effective, but for the eligibility of a first applicant for 180-day exclusivity under this clause. (bb) At least 30 months have passed since the date of submission of an application for the drug by at least one first applicant. (cc) Approval of an application for the drug submitted by at least one first applicant is not precluded under clause (iii). (dd) No application for the drug submitted by any first applicant is effectively approved on the date that the conditions under items (aa), (bb), and (cc) are all met, regardless of whether such application is subsequently approved. . (b) Applicability The amendments made by subsection (a) shall apply only with respect to an application filed under section 505(j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)

Summary: Expanding Access to Low-Cost Generics Act of 2021 This bill modifies provisions related to market exclusivity for a generic drug. Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to a first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon a first applicant's commercial marketing of the drug. The bill authorizes the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) a first applicant's application has been pending for at least 30 months, (3) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant, and (4) no first applicant's application has been effectively approved on the date that all such conditions are met.