AMOXIL
LOE ApproachingNDAORALFOR SUSPENSIONPriority Review
Approved
Jan 1974
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
Priority Review
AMOXIL by GSK is drug. Approved for the treatment of infections due to susceptible (only β-lactamase–negative) isolates of the designated bacteria in the conditions listed below: 1. First approved in 1974.
Drug data last refreshed 18h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMOXIL is amoxicillin, a beta-lactam antibiotic approved in 1974 that treats infections caused by susceptible gram-positive and gram-negative bacteria including Streptococcus pneumoniae, Haemophilus influenzae, and Escherichia coli. It works by inhibiting bacterial cell wall biosynthesis, leading to bactericidal activity during active bacterial multiplication. Available as oral suspension and multiple tablet formulations with rapid gastric acid stability and absorption.
LOE Approaching
Product is approaching loss of exclusivity with significant generic competition pressure (30% competitive intensity), indicating transition from brand defense to managed decline phase with smaller commercial teams.
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.