NDAORALTABLETPriority Review
Approved
Aug 1984
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
Priority Review
AUGMENTIN '500' (amoxicillin; clavulanate potassium) by Pfizer. Approved for infections due to susceptible strains of designated microorganisms, the treatment of infections due to susceptible (only β-lactamase–negative) isolates of streptococcus species, the treatment of infections due to susceptible (only β-lactamase–negative) isolates of escherichia coli and 3 more indications. First approved in 1984.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AUGMENTIN '500' is an oral combination antibiotic tablet containing amoxicillin and clavulanate potassium, approved in 1984. It treats bacterial infections caused by susceptible strains including Streptococcus, Escherichia coli, Proteus mirabilis, and Enterococcus faecalis. Clavulanate acts as a β-lactamase inhibitor, protecting amoxicillin from enzymatic degradation.
LOE Approaching
Product approaching loss of exclusivity with declining competitive pressure (30%), indicating potential team consolidation and focus on cost management and generics transition support.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
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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.