Generic entry timeline

Sodium Thiosulfate generics — when can they launch?

Sodium Thiosulfate (SODIUM THIOSULFATE) · Us Army · 13 active US patents · 0 expired

Earliest patent expiry
2030-02-10
4 years remaining
Full patent estate to
2039-07-01
complete protection through 2039
FDA approval
1992
Us Army

Where Sodium Thiosulfate sits in the generic timeline

Mid-term cliff: earliest active US patent for Sodium Thiosulfate 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
  • Formulation — 4 patents
  • Composition of Matter — 1 patent

FDA U-codes carved out by Sodium Thiosulfate 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-3682(no description)
U-3390(no description)
U-2015(no description)
U-1419(no description)
U-3443(no description)
U-3948(no description)
U-3952(no description)
U-3898(no description)

Sample patent estate

Showing 6 of 13 active US patents. View full estate on the Sodium Thiosulfate drug page →

  • US11753301 Method of Use · expires 2030-02-10
    This patent protects methods of treatment using pharmaceutically acceptable sodium thiosulfate.
    USPTO title: Sodium thiosulfate-containing pharmaceutical compositions
  • US12304813 Formulation · expires 2030-02-10
    This patent protects pharmaceutical compositions containing sodium thiosulfate and methods for producing and using it.
    USPTO title: Sodium thiosulfate-containing pharmaceutical compositions
  • US9585912 Composition of Matter · expires 2030-07-07
    This patent protects pharmaceutical compositions containing sodium thiosulfate, methods for determining its purity, producing it, and using it for treatment.
    USPTO title: Sodium thiosulfate-containing pharmaceutical compositions
  • US10479686 Method of Use · expires 2030-07-07
    This patent protects methods of treatment using pharmaceutically acceptable sodium thiosulfate.
    USPTO title: Sodium thiosulfate-containing pharmaceutical compositions
  • US9345724 Method of Use · expires 2030-07-07
    This patent protects methods of treatment using pharmaceutically acceptable sodium thiosulfate.
    USPTO title: Sodium thiosulfate-containing pharmaceutical compositions
  • US8496973 Method of Use · expires 2031-03-29
    This patent protects methods of treatment using pharmaceutically acceptable sodium thiosulfate.
    USPTO title: Sodium thiosulfate-containing pharmaceutical compositions

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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