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 16h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMOXIL (amoxicillin) is an oral penicillin-class bactericidal antibiotic that inhibits bacterial cell wall synthesis during active multiplication. It is indicated for a broad spectrum of bacterial infections and is rapidly absorbed from the gastrointestinal tract, achieving peak serum levels within 1-2 hours. The drug diffuses readily into most body tissues and fluids except the central nervous system unless meninges are inflamed.
LOE Approaching
As LOE approaches, commercial teams are transitioning from growth to defensive strategies; expect consolidation of field roles and shift toward generic partnership or lifecycle extension 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.