NDAORALFOR SUSPENSION
Approved
Apr 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
AMOXIL (amoxicillin) by Pfizer is 12. First approved in 1999.
Drug data last refreshed 35m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMOXIL (amoxicillin) is an oral beta-lactam antibiotic that works by inhibiting bacterial cell wall synthesis, making it bactericidal against susceptible organisms during active multiplication. It is used to treat a broad range of bacterial infections including respiratory, urinary, gastrointestinal, and skin infections. The drug is stable in gastric acid and rapidly absorbed orally, achieving therapeutic levels in most body tissues and fluids within 1-2 hours.
LOE Approaching
Product is in late-stage lifecycle with declining exclusivity; commercial teams are likely focused on cost management and defending market share against generic and alternative competitors rather than growth initiatives.
Mechanism of Action
12.1 Mechanism of Action Amoxicillin is an antibacterial drug [see Microbiology ( )]. 12.3 Pharmacokinetics Absorption: Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. The effect of food on the absorption of amoxicillin from the tablets and…
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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.