NDAORALTABLET, CHEWABLE
Approved
Apr 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
AMOXIL (amoxicillin) by Pfizer is drug. Approved for helicobacter pylori infection, pneumonia, otitis media and 11 more indications. First approved in 1999.
Drug data last refreshed 23h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMOXIL (amoxicillin) is an oral beta-lactam antibiotic that inhibits bacterial cell wall biosynthesis, making it bactericidal against susceptible organisms. It treats 13+ indications including respiratory tract infections, urinary tract infections, otitis media, sinusitis, and H. pylori infection. The drug is rapidly absorbed orally and distributed to most body tissues, with 60% renal excretion within 6-8 hours.
LOE Approaching
As loss of exclusivity approaches, brand roles shift toward defensive marketing, generic transition support, and line extension strategy; team size typically contracts post-LOE.
Mechanism of Action
drug. [see Microbiology (12.4)]. 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 suspension of Amoxicillin has been partially…
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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.