S4332
Referred to committee
Medication Competition Act
- Federal
- Senate
- Introduced Apr 16, 2026
- Session 119
Bill Text
Version ISThis Act may be cited as the Medication Competition Act.
Section 351(k)(9)(A)(iv) of the Public Health Service Act (42 U.S.C. 262(k)(9)(A)(iv)) is amended—
by inserting determine any applicable exclusivity period under paragraph (6) or (7), and shall after the Secretary shall;
by striking the period at the end and inserting , as follows:; and
by adding at the end the following:
With respect to a biological product licensed under this subsection on or after the date of enactment of the Medication Competition Act, the Secretary shall include on the list published under this subparagraph any applicable exclusivity period under paragraph (6), not later than 30 days after the earliest date on which an expiration date of such an exclusivity period can be known pursuant to paragraph (6).
With respect to a biological product licensed under this subsection before the date of enactment of the Medication Competition Act, the Secretary shall include on the list published under this subparagraph any applicable exclusivity period under paragraph (6), not later than 30 days after the later of such date of enactment or the earliest date on which an expiration date of such an exclusivity period can be known pursuant to paragraph (6).
With respect to a biological product licensed under subsection (a) on or after the date of enactment of the Medication Competition Act, the Secretary shall include on the list published under this subparagraph the expiration date of any exclusivity period under paragraph (7), not later than 30 days after licensure of the biological product.
With respect to any biological product licensed under subsection (a) before the date of enactment of the Medication Competition Act, the Secretary shall include on the list published under this subparagraph the expiration date of any exclusivity period under paragraph (7), not later than 2 years after such date of enactment.
Section 351(k)(9)(A)(iv) of the Public Health Service Act (42 U.S.C. 262(k)(9)(A)(iv)) is amended—
by inserting determine any applicable exclusivity period under paragraph (6) or (7), and shall after the Secretary shall;
by striking the period at the end and inserting , as follows:; and
by adding at the end the following:
With respect to a biological product licensed under this subsection on or after the date of enactment of the Medication Competition Act, the Secretary shall include on the list published under this subparagraph any applicable exclusivity period under paragraph (6), not later than 30 days after the earliest date on which an expiration date of such an exclusivity period can be known pursuant to paragraph (6).
With respect to a biological product licensed under this subsection before the date of enactment of the Medication Competition Act, the Secretary shall include on the list published under this subparagraph any applicable exclusivity period under paragraph (6), not later than 30 days after the later of such date of enactment or the earliest date on which an expiration date of such an exclusivity period can be known pursuant to paragraph (6).
With respect to a biological product licensed under subsection (a) on or after the date of enactment of the Medication Competition Act, the Secretary shall include on the list published under this subparagraph the expiration date of any exclusivity period under paragraph (7), not later than 30 days after licensure of the biological product.
With respect to any biological product licensed under subsection (a) before the date of enactment of the Medication Competition Act, the Secretary shall include on the list published under this subparagraph the expiration date of any exclusivity period under paragraph (7), not later than 2 years after such date of enactment.
Legislative Timeline
2 actions-
Introduced in Senate
-
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.