Generic entry timeline

Tibsovo generics — when can they launch?

Tibsovo (IVOSIDENIB) · Servier · 10 active US patents · 0 expired

Earliest patent expiry
2030-06-21
4 years remaining
Full patent estate to
2039-06-07
complete protection through 2039
FDA approval
2018
Servier

Where Tibsovo sits in the generic timeline

Mid-term cliff: earliest active US patent for Tibsovo 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.

  • Method of Use — 9 patents
  • Formulation — 1 patent

FDA U-codes carved out by Tibsovo 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-2784(no description)
U-3215(no description)
U-3742(no description)
U-2534(no description)
U-3384(no description)
U-3387(no description)
U-3214(no description)

Sample patent estate

Showing 6 of 10 active US patents. View full estate on the Tibsovo drug page →

  • US10610125 Method of Use · expires 2030-06-21
    This patent protects methods of treating and evaluating subjects with neoactive mutants.
    USPTO title: Methods and compositions for cell-proliferation-related disorders
  • US10717764 Method of Use · expires 2033-01-18
    This patent protects methods of treating cancer with a mutant IDH1/2 allele by administering a compound described in the patent.
    USPTO title: Therapeutically active compounds and their methods of use
  • US11667673 Method of Use · expires 2033-01-18
    This patent protects methods of treating cancer with a mutant IDH1/2 allele by administering a compound described in the patent.
    USPTO title: Therapeutically active compounds and their methods of use
  • US9850277 Method of Use · expires 2033-01-18
    This patent protects methods of treating cancer caused by mutant IDH1/2 alleles by administering a compound described in the patent.
    USPTO title: Therapeutically active compositions and their methods of use
  • US9474779 Method of Use · expires 2033-08-19
    This patent protects methods of treating cancer caused by mutant IDH1/2 alleles by administering a compound described in the patent.
    USPTO title: Therapeutically active compositions and their methods of use
  • US10449184 Formulation · expires 2035-03-13
    This patent protects pharmaceutical compositions of therapeutically active compounds for treating cancer.
    USPTO title: Pharmaceutical compositions of therapeutically active compounds

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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