NDAORALFOR SUSPENSION
Approved
Jun 2001
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
5/8 — Partial
AUGMENTIN ES-600 (amoxicillin and clavulanate potassium) by Pfizer is es-600 is an antibacterial drug [see microbiology ()] . Approved for equal to 40 kg with: recurrent, persistent acute otitis media due to s, acute otitis media due to s and 7 more indications. First approved in 2001.
Drug data last refreshed 2h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AUGMENTIN ES-600 is an oral suspension combining amoxicillin and clavulanate potassium, a beta-lactamase inhibitor combination designed to treat bacterial infections resistant to amoxicillin alone. It is indicated for recurrent and persistent acute otitis media and other infections caused by susceptible bacteria, with particular utility against drug-resistant pathogens. The clavulanate component protects amoxicillin from degradation by bacterial beta-lactamases, extending its spectrum of activity.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30%), signaling potential team downsizing and transition planning for brand extension or legacy support roles.
Mechanism of Action
ES-600 is an antibacterial drug [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.