What does Preamble of Medication Competition Act do?

This bill requires the Secretary of Health and Human Services to determine the exclusivity periods for licensed biological products.

What does SHORT TITLE. of Medication Competition Act do?

This bill is formally titled the Medication Competition Act.

What does DETERMINATION OF REFERENCE PRODUCT EXCLUSIVITY. of Medication Competition Act do?

This section amends Section 351(k)(9)(A)(iv) of the Public Health Service Act. It establishes procedures for determining reference product exclusivity. The Secretary must publish a list including exclusivity periods for biological products. The timing for including exclusivity periods on the list depends on whether the product was licensed before or after the enactment of the Medication Competition Act. For products licensed on or after the enactment date, the Secretary must include exclusivity periods within 30 days of knowing the expiration date. For products licensed before the enactment date, the timing varies, with a maximum of two years for reference products.

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Medication Competition Act

Last updated: 4/16/2026 · Introduced: 4/16/2026

Author: Maggie Hassan (D-NH)

TL;DR (AI)

The bill requires the Secretary of Health and Human Services to determine and publish exclusivity periods for licensed biological products.
For biological products licensed after the bill's enactment, the Secretary must publish exclusivity periods within 30 days of knowing the expiration date.
The bill amends the Public Health Service Act to establish procedures for determining reference product exclusivity.

119th Congressin committeeOfficial page

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Other Sections

Includes provisions on preamble, short title., and 1 more.

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