Sponsors (2)
The bill extends 180 days of exclusivity for certain orphan drugs, strengthening incentives to supply scarce treatments but delaying competition and raising costs for patients, insurers, and taxpayers.
Patients with rare/orphan conditions will be more likely to keep receiving scarce orphan drugs because manufacturers have stronger incentives to continue supplying and investing in those products during an extra 180 days of exclusivity.
Manufacturers of covered orphan drugs (including small business owners) gain an additional 180 days of market exclusivity, delaying generic/biosimilar competition and preserving higher revenues for the incumbent producers.
Patients, insurers (including Medicare and Medicaid), hospitals, and taxpayers will face higher drug prices and increased public and private spending for an additional 180 days because competition from generics/biosimilars is delayed.
Potential generic/biosimilar competitors and some patients may be disadvantaged because the exclusivity extension favors incumbent manufacturers, entrenching market power and reducing near-term access to cheaper alternatives.
Based on analysis of 2 sections of legislative text.
Extends certain FDA exclusivity and patent-related approval-delay periods by 180 days for qualifying orphan drugs tied to IND/505(i) submissions during the COVID‑19 emergency period.
Introduced February 25, 2026 by Josh S. Gottheimer · Last progress February 25, 2026
Extends multiple FDA exclusivity periods and certain patent-related approval-delay periods by 180 days for specific orphan drugs whose investigational new drug (IND)/505(i) applications were submitted during the COVID‑19 emergency period and whose related 505(b) or 351(a) approvals rely on that IND. The extension applies to biologics exclusivity, NDA exclusivity and related three-year/three-month listed-drug periods, orphan-drug exclusivity, and conforming statutory timeframes that affect generic and biosimilar entry. The change is effective on enactment and uses a defined COVID‑19 emergency period beginning December 1, 2019.