S. 2620

119th CONGRESS 1st Session

To amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications.

IN THE SENATE OF THE UNITED STATES · July 31, 2025 · Sponsor: Mr. Durbin · Committee: Committee on Health, Education, Labor, and Pensions

Table of contents

• S. 2620
  • SEC. 1. Short title
  • SEC. 2. Amendments to ANDA approval provisions

SEC. 1. Short title

• This Act may be cited as the or the .

SEC. 2. Amendments to ANDA approval provisions

• Section 505 of the Federal Food, Drug, and Cosmetic Act () is amended— 21 U.S.C. 355
  • in subsection (c)(2) by adding at the end the following: ; Reforming Evergreening and Manipulation that Extends Drug Years Act.
  • in subsection (c)(3)(C)—
    • in the matter preceding clause (i)—
      • (i) by striking and all that follows through the period at the end of the first sentence and inserting ; and
      • (ii) by striking an action is brought beforeand inserting an action with respect to a patent or a covered patent, as applicable, is brought before; and
    • in clause (i), by striking decides that the patentand inserting decides that the patent or the covered patent, as applicable;
  • in the second sentence of subsection (c)(3)(E)(ii), by inserting after ;
  • in subsection (j)(5)(B)(iii)—
    • in the matter preceding subclause (I)—
      • (i) by striking and all that follows through the period at the end of the first sentence and inserting ; and
      • (ii) by striking an action is brought beforeand inserting an action with respect to a patent or a covered patent, as applicable, is brought before; and
    • in subclause (I), by striking decides that the patentand inserting decides that the patent or covered patent, as applicable,; and
  • in the second sentence of subsection (j)(5)(F)(ii), by inserting after .