Generic entry timeline

Aldactone generics — when can they launch?

Aldactone (spironolactone) · Generic (originally Searle/Pfizer) · 8 active US patents · 0 expired

Earliest patent expiry
2036-10-28
10 years remaining
Full patent estate to
2036-10-28
complete protection through 2036
FDA approval
1960-01-01
Generic (originally Searle/Pfizer)

Where Aldactone sits in the generic timeline

Long-dated protection: earliest active US patent for Aldactone extends to 2036 (~10 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.

  • Formulation — 6 patents
  • Method of Use — 2 patents

FDA U-codes carved out by Aldactone 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-2109(no description)

Sample patent estate

Showing 6 of 8 active US patents. View full estate on the Aldactone drug page →

  • US10660907 Formulation · expires 2036-10-28
    This patent protects a stable, ready-to-use liquid formulation of spironolactone, which is also known as Aldactone.
    USPTO title: Spironolactone aqueous compositions
  • US11395828 Method of Use · expires 2036-10-28
    This patent protects a stable, ready-to-use liquid formulation of spironolactone and its method of use.
    USPTO title: Spironolactone aqueous compositions
  • US10888570 Formulation · expires 2036-10-28
    This patent protects a stable, ready-to-use liquid formulation of spironolactone, which is also known as Aldactone.
    USPTO title: Spironolactone aqueous compositions
  • US11389461 Formulation · expires 2036-10-28
    This patent protects a stable, ready-to-use liquid formulation of spironolactone, which is also known as Aldactone.
    USPTO title: Spironolactone aqueous compositions
  • US11491166 Formulation · expires 2036-10-28
    This patent protects a stable, ready-to-use liquid formulation of spironolactone, which is also known as Aldactone.
    USPTO title: Spironolactone aqueous compositions
  • US10493083 Formulation · expires 2036-10-28
    This patent protects a stable, ready-to-use liquid formulation of spironolactone, which is also known as Aldactone.
    USPTO title: Spironolactone aqueous 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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