Generic entry timeline

REGORAFENIB generics — when can they launch?

REGORAFENIB (REGORAFENIB) · · 4 active US patents · 0 expired

Earliest patent expiry
2030-06-02
4 years remaining
Full patent estate to
2032-07-09
complete protection through 2032
FDA approval
2012
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Where REGORAFENIB sits in the generic timeline

Mid-term cliff: earliest active US patent for REGORAFENIB expires in 2030 (~4 years). Generic developers typically begin ANDA bioequivalence studies 3-4 years ahead of this date. Paragraph IV filings + Hatch-Waxman 30-month stays may shift the effective entry by another 18-36 months.

Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.

Patent estate by type — active patents

Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.

  • Composition of Matter — 2 patents
  • Method of Use — 1 patent
  • Formulation — 1 patent

FDA U-codes carved out by REGORAFENIB patents

Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.

U-codeDescription
U-1506(no description)

Sample patent estate

Showing 4 of 4 active US patents. View full estate on the REGORAFENIB drug page →

  • US8680124 Method of Use · expires 2030-06-02
    This patent protects a method of treating cancers that have developed resistance to KIT inhibitors by administering a specific compound called DAST.
    USPTO title: Treatment of cancers with acquired resistance to kit inhibitors
  • US8637553 Composition of Matter · expires 2031-02-16
    This patent protects a compound of Formula (I) and its salts, prodrugs, and metabolites for treating diseases mediated by raf, VEGFR, PDGFR, p38, and flt-3.
    USPTO title: Fluoro substituted omega-carboxyaryl diphenyl urea for the treatment and prevention of diseases and conditions
  • US9458107 Formulation · expires 2031-04-08
    This patent protects a process for preparing the drug substance 4-(4-[({[4-chloro-3-(trifluoromethyl)-phenyl]amino}carbonyl)amino]-3-fluorophenoxy)-N-methylpyridine-2-carboxamide.
    USPTO title: Process for the preparation of 4-{4-[({[4 chloro-3-(trifluoromethyl)-phenyl]amino}carbonyl)amino]-3-fluorphenoxy-N-ethylpyridie-carboxamide, its salts and monohydrate
  • US9957232 Composition of Matter · expires 2032-07-09
    This patent protects the compound 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide monohydrate.
    USPTO title: 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide monohydrate

Sources

Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.

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