To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period.
Sponsors
Tina Smith
D-MN | Primary Sponsor
Legislative Progress
ReportedReported by Mr. Sanders, with an amendment
Reported by Mr. Sanders, with an amendment
Ms. Smith (for herself and Mr. Braun) introduced the following …
Summary
What This Bill Does
Modifies the 180-day exclusivity period for first generic drug applicants by allowing FDA to approve later generic applicants if the first filer hasnt launched after 33 months. Prevents gaming of the system where companies file first but delay launching.
Who Benefits and How
- Generic drug manufacturers (other than first filers) can enter markets sooner when first filers dont launch
- Consumers and patients gain access to cheaper generic drugs faster when first filers stall
- Health insurers and PBMs reduce drug costs by having more generic competition sooner
Who Bears the Burden and How
- First-to-file generic companies lose guaranteed exclusivity if they dont launch within 33 months
- Brand-name pharmaceutical companies face faster generic competition when first filers are bypassed
Key Provisions
- FDA may approve later generics if first applicant hasnt launched within 33 months
- Later applicants must certify ability to market within 75 days of approval
- First applicant retains 180-day head start if they do launch before later approval
Evidence Chain:
This summary is derived from the structured analysis below. See "Detailed Analysis" for per-title beneficiaries/burden bearers with clause-level evidence links.
Primary Purpose
Allows FDA to approve subsequent generic drug applicants when first applicants fail to launch within 33 months, expanding access to low-cost generics
Policy Domains
Legislative Strategy
"Close loophole allowing first-to-file generics to delay market entry while blocking competitors"
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "the_secretary"
- → Secretary of HHS (via FDA)
Key Definitions
Terms defined in this bill
First generic drug applicant to file a paragraph IV certification challenging patent
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology