NDAORALTABLET
Approved
Feb 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
AUGMENTIN '875' (amoxicillin and clavulanate potassium) by Pfizer is [see microbiology ( )] . Approved for the following infections in adults, skin structure infections urinary tract infections limitations of use, indicating no beta-lactamase production and 11 more indications. First approved in 1996.
Drug data last refreshed 12h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AUGMENTIN '875' is an oral fixed-dose combination of amoxicillin (a beta-lactam antibiotic) and clavulanate potassium (a beta-lactamase inhibitor) approved for treating bacterial infections in adults including skin and urinary tract infections. The clavulanate component protects amoxicillin from enzymatic degradation by beta-lactamase-producing bacteria, restoring or extending its spectrum of activity.
LOE Approaching
As a mature product approaching loss of exclusivity with moderate competitive pressure (30%), the brand team is likely focused on lifecycle management and defending market share against generics and newer alternatives.
Mechanism of Action
[see Microbiology ( )] .
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.