Generic entry timeline

Itovebi generics — when can they launch?

Itovebi (INAVOLISIB) · Genentech Inc · 14 active US patents · 0 expired

Earliest patent expiry
2030-09-27
4 years remaining
Full patent estate to
2038-06-14
complete protection through 2038
FDA approval
2025
Genentech Inc

Where Itovebi sits in the generic timeline

Mid-term cliff: earliest active US patent for Itovebi 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 — 8 patents
  • Composition of Matter — 6 patents

FDA U-codes carved out by Itovebi 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-4024(no description)

Sample patent estate

Showing 6 of 14 active US patents. View full estate on the Itovebi drug page →

  • US8242104 Composition of Matter · expires 2030-09-27
    This patent protects benzoxazepin compounds that inhibit lipid kinases, including p110 alpha and other PI3K isoforms, for treating disorders such as cancer.
    USPTO title: Benzoxazepin P13K inhibitor compounds and methods of use
  • US8242104 Composition of Matter · expires 2030-09-27
    This patent protects benzoxazepin compounds that inhibit lipid kinases, including p110 alpha and other PI3K isoforms, for treating disorders such as cancer.
    USPTO title: Benzoxazepin P13K inhibitor compounds and methods of use
  • US8343955 Method of Use · expires 2030-09-27
    This patent protects methods of using benzoxazepin compounds to inhibit lipid kinases and treat disorders such as cancer.
    USPTO title: Benzoxazepin PI3K inhibitor compounds and methods of use
  • US8343955 Method of Use · expires 2030-09-27
    This patent protects methods of using benzoxazepin compounds to inhibit lipid kinases and treat disorders such as cancer.
    USPTO title: Benzoxazepin PI3K inhibitor compounds and methods of use
  • US10851091 Composition of Matter · expires 2036-07-01
    This patent protects benzoxazepin oxazolidinone compounds with phosphoinositide-3 kinase (PI3K) modulation activity, as well as pharmaceutical compositions and methods of using these compounds.
    USPTO title: Benzoxazepin oxazolidinone compounds and methods of use
  • US10851091 Composition of Matter · expires 2036-07-01
    This patent protects benzoxazepin oxazolidinone compounds with phosphoinositide-3 kinase (PI3K) modulation activity, as well as pharmaceutical compositions and methods of using these compounds.
    USPTO title: Benzoxazepin oxazolidinone compounds and methods of use

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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