Generic entry timeline

CUPRIC SULFATE generics — when can they launch?

CUPRIC SULFATE (CUPRIC SULFATE) · · 15 active US patents · 0 expired

Earliest patent expiry
2041-07-01
15 years remaining
Full patent estate to
2041-07-01
complete protection through 2041
FDA approval
1987

Where CUPRIC SULFATE sits in the generic timeline

Long-dated protection: earliest active US patent for CUPRIC SULFATE extends to 2041 (~15 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.

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 — 6 patents

FDA U-codes carved out by CUPRIC SULFATE 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-3899(no description)
U-3900(no description)

Sample patent estate

Showing 6 of 15 active US patents. View full estate on the CUPRIC SULFATE drug page →

  • US11998565 Formulation · expires 2041-07-01
    This patent protects a stable injectable composition for parenteral nutrition that includes water and specific amounts of zinc, copper, selenium, or manganese per milliliter.
    USPTO title: Trace element compositions, methods of making and use
  • US12150957 Method of Use · expires 2041-07-01
    This patent protects a stable injectable composition for parenteral nutrition that includes zinc, copper, selenium, or manganese.
    USPTO title: Trace element compositions, methods of making and use
  • US12150956 Method of Use · expires 2041-07-01
    This patent protects a stable injectable composition for parenteral nutrition that includes zinc, copper, selenium, or manganese.
    USPTO title: Trace element compositions, methods of making and use
  • US11998565 Formulation · expires 2041-07-01
    This patent protects a stable injectable composition for parenteral nutrition that includes water and specific amounts of zinc, copper, selenium, or manganese per milliliter.
    USPTO title: Trace element compositions, methods of making and use
  • US12150956 Method of Use · expires 2041-07-01
    This patent protects a stable injectable composition for parenteral nutrition that includes zinc, copper, selenium, or manganese.
    USPTO title: Trace element compositions, methods of making and use
  • US12150956 Method of Use · expires 2041-07-01
    This patent protects a stable injectable composition for parenteral nutrition that includes zinc, copper, selenium, or manganese.
    USPTO title: Trace element compositions, methods of making and 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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