Generic entry timeline

POMALIDOMIDE generics — when can they launch?

POMALIDOMIDE (POMALIDOMIDE) · · 24 active US patents · 0 expired

Earliest patent expiry
2030-05-19
4 years remaining
Full patent estate to
2031-12-21
complete protection through 2031
FDA approval
2013
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Where POMALIDOMIDE sits in the generic timeline

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

  • Other — 12 patents
  • Formulation — 8 patents
  • Composition of Matter — 4 patents

Sample patent estate

Showing 6 of 24 active US patents. View full estate on the POMALIDOMIDE drug page →

  • US10555939 Formulation · expires 2030-05-19
    This patent protects formulations of the drug 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione, which is a compound related to POMALIDOMIDE.
    USPTO title: Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione
  • US10555939 Formulation · expires 2030-05-19
    This patent protects formulations of the drug 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione, which is a compound related to POMALIDOMIDE.
    USPTO title: Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione
  • US10555939 Formulation · expires 2030-05-19
    This patent protects formulations of the drug 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione, which is a compound related to POMALIDOMIDE.
    USPTO title: Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione
  • US10555939 Formulation · expires 2030-05-19
    This patent protects formulations of the drug 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione, which is a compound related to POMALIDOMIDE.
    USPTO title: Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione
  • US9993467 Formulation · expires 2030-05-19
    This patent protects formulations of the drug 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione, which is a compound related to POMALIDOMIDE.
    USPTO title: Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione
  • US9993467 Formulation · expires 2030-05-19
    This patent protects formulations of the drug 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione, which is a compound related to POMALIDOMIDE.
    USPTO title: Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione

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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