Generic entry timeline

AMLODIPINE BENZOATE generics — when can they launch?

AMLODIPINE BENZOATE (AMLODIPINE BENZOATE) · · 13 active US patents · 0 expired

Earliest patent expiry
2037-10-06
11 years remaining
Full patent estate to
2039-04-11
complete protection through 2039
FDA approval
2019
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Where AMLODIPINE BENZOATE sits in the generic timeline

Long-dated protection: earliest active US patent for AMLODIPINE BENZOATE extends to 2037 (~11 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 — 8 patents
  • Method of Use — 5 patents

FDA U-codes carved out by AMLODIPINE BENZOATE 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-3447(no description)
U-39(no description)
U-3Treatment of inflammatory conditions

Sample patent estate

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

  • US11701326 Formulation · expires 2037-10-06
    This patent protects stable amlodipine liquid formulations for treating hypertension and Coronary Artery Disease.
    USPTO title: Amlodipine formulations
  • US11918685 Method of Use · expires 2037-10-06
    This patent protects stable amlodipine liquid formulations and methods of using them to treat hypertension and Coronary Artery Disease.
    USPTO title: Amlodipine formulations
  • US10952998 Formulation · expires 2037-10-06
    This patent protects stable amlodipine oral liquid formulations for treating hypertension and Coronary Artery Disease.
    USPTO title: Amlodipine formulations
  • US10959991 Method of Use · expires 2037-10-06
    This patent protects stable amlodipine oral liquid formulations and methods of using them to treat hypertension and Coronary Artery Disease.
    USPTO title: Amlodipine formulations
  • US12336984 Method of Use · expires 2037-10-06
    This patent protects stable amlodipine oral liquid formulations and methods of using them to treat hypertension and Coronary Artery Disease.
    USPTO title: Amlodipine formulations
  • US12383498 Formulation · expires 2037-10-06
    This patent protects stable amlodipine liquid formulations for treating hypertension and Coronary Artery Disease.
    USPTO title: Amlodipine formulations

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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