Generic entry timeline

Bumex generics — when can they launch?

Bumex (BUMETANIDE) · · 4 active US patents · 0 expired

Earliest patent expiry
2040-12-04
15 years remaining
Full patent estate to
2045-05-14
complete protection through 2045
FDA approval
1983
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Where Bumex sits in the generic timeline

Long-dated protection: earliest active US patent for Bumex extends to 2040 (~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 — 3 patents
  • Formulation — 1 patent

FDA U-codes carved out by Bumex 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-4279(no description)

Sample patent estate

Showing 4 of 4 active US patents. View full estate on the Bumex drug page →

  • US12329731 Method of Use · expires 2040-12-04
    This patent protects methods and compositions for administering bumetanide through intranasal, sublingual, and subcutaneous routes to treat edema resistant to oral diuretics.
    USPTO title: Methods and compositions for treating edema refractory to oral diuretics
  • US11260038 Method of Use · expires 2040-12-04
    This patent protects methods and compositions for administering bumetanide through intranasal, sublingual, and subcutaneous routes to treat edema that does not respond to oral diuretics.
    USPTO title: Methods and compositions for treating edema refractory to oral diuretics
  • US11123319 Formulation · expires 2040-12-04
    This patent protects methods and compositions for administering bumetanide through intranasal, sublingual, and subcutaneous routes to treat edema resistant to oral diuretics.
    USPTO title: Methods and compositions for treating edema refractory to oral diuretics
  • US12558330 Method of Use · expires 2045-05-14
    This patent protects methods and compositions for administering bumetanide through intranasal, sublingual, and subcutaneous routes to treat edema resistant to oral diuretics.
    USPTO title: Methods and compositions for treating edema refractory to oral diuretics

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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