14. Department of Health and Human Services · Notable
Prohibit brand-name makers from parking first-to-file generic rights
Not started
Printed page 456 14. Department of Health and Human Services
“Specifically, the FDA should prohibit pharmaceutical companies from purposely sitting on their legally available right to be the first to sell generic versions of their drugs.”
What has happened
- Not started
FDA has issued no rule, guidance or policy prohibiting a first-to-file applicant from parking its 180-day generic exclusivity. Full-text Federal Register search for "180-day exclusivity" since 2025-01-20 returns one document, a CMS drug-pricing model proposal unrelated to the ask, and none of FDA's 184 in-window rules and proposed rules touches generic exclusivity.
No action found yet. This entry is the starting point, not a finding.
Research log
What was searched, and what didn’t count as evidence
Research notes
- The statutory forfeiture provisions of 21 U.S.C. 355(j)(5)(D), added in 2003, are the existing federal answer to parking. Nothing in the window adds to them.
- One search covered this ask together with the other asks on its pages.
- Action
- restrict
- Object
- first-to-file generic marketing rights
- ID
- 1224