NDAORALFOR SUSPENSION
Approved
Aug 1984
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
AUGMENTIN '250' (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 1984.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AUGMENTIN '250' is an oral suspension combining amoxicillin (a beta-lactam antibiotic) and clavulanate potassium (a beta-lactamase inhibitor) approved since 1984. It treats skin and urinary tract infections in adults by inhibiting bacterial cell wall synthesis while protecting amoxicillin from enzymatic degradation. The fixed combination is designed to overcome resistance mechanisms and maintain effectiveness against beta-lactamase-producing organisms.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); brand team focus shifting from growth maintenance to lifecycle management and generic transition planning.
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.