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 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Augmentin '875' is an oral combination antibiotic tablet containing amoxicillin and clavulanate potassium, used to treat bacterial infections in adults including skin structure and urinary tract infections. Clavulanate potassium acts as a beta-lactamase inhibitor, protecting amoxicillin from enzymatic degradation and restoring efficacy against resistant organisms. The combination is indicated only when beta-lactamase production is suspected or confirmed.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), signaling consolidation of brand team and shift toward generic transition strategy.
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.