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H.R. 10150

BillFederalHouseIn Committee
To amend the Federal Food, Drug, and Cosmetic Act to provide a period of market exclusivity for botanical drugs, and for other purposes.
About This Bill
Committee
Latest Action · August 27, 2026
Referred to the House Committee on Energy and Commerce.
Introduced
August 27, 2026
Cosponsors (1)
0D 1R
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Summary

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This bill creates a new market exclusivity period for botanical drugs approved by the FDA. Under current law, botanical drugs—medications made from plants that can treat multiple biological pathways simultaneously—receive limited protection after approval, which discourages companies from investing in their development. The legislation grants a 12-year period of market exclusivity during which generic or biosimilar versions cannot be approved, matching or exceeding protections given to other complex drug categories. The bill applies to any botanical drug approved after the bill's enactment and aims to incentivize research into plant-based treatments for chronic and age-related diseases. The measure reflects congressional recognition that botanical drugs face unique manufacturing and regulatory challenges—such as ensuring consistency in plant-derived materials—that justify additional incentives to encourage innovation in this sector.

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