Generic entry timeline

LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN generics — when can they launch?

LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) · · 5 active US patents · 0 expired

Earliest patent expiry
2028-08-15
2 years remaining
Full patent estate to
2041-09-18
complete protection through 2041
FDA approval
2022
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Where LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN sits in the generic timeline

Imminent generic cliff: earliest active US patent for LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN expires in 2028 (~2 years from today). ANDA filers are likely already preparing Paragraph IV certifications. Expect first-filer 180-day exclusivity competition imminently.

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 — 4 patents
  • Composition of Matter — 1 patent

FDA U-codes carved out by LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN 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-4169(no description)

Sample patent estate

Showing 5 of 5 active US patents. View full estate on the LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN drug page →

  • US11318121 Method of Use · expires 2028-08-15
    This patent protects methods for using PSMA binding ligand-linker conjugates, including pharmaceutical compositions containing them, for delivering therapeutic, diagnostic, and imaging agents.
    USPTO title: PSMA binding ligand-linker conjugates and methods for using
  • US10406240 Method of Use · expires 2028-08-15
    This patent protects methods for using PSMA binding ligand-linker conjugates, including pharmaceutical compositions containing them, for delivering therapeutic, diagnostic, and imaging agents.
    USPTO title: PSMA binding ligand-linker conjugates and methods for using
  • US10398791 Composition of Matter · expires 2034-10-17
    This patent protects compounds represented by Formulae (Ia) or (Ib) for use as radiopharmaceuticals in the treatment of prostate cancer.
    USPTO title: Labeled inhibitors of prostate specific membrane antigen (PSMA), their use as imaging agents and pharmaceutical agents for the treatment of prostate cancer
  • US11951190 Method of Use · expires 2035-11-12
    This patent protects the use of labeled inhibitors of prostate specific membrane antigen (PSMA) for the treatment of prostate cancer.
    USPTO title: Use of labeled inhibitors of prostate specific membrane antigen (PSMA), as agents for the treatment of prostate cancer
  • US12208102 Method of Use · expires 2041-09-18
    This patent protects methods of treating cancers that express PSMA with a compound of formula 1.
    USPTO title: Methods of treating cancer

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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