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 5h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AUGMENTIN ES-600 is an oral suspension combining amoxicillin and clavulanate potassium, indicated for recurrent and acute otitis media in pediatric patients weighing ≥40 kg. The clavulanate potassium component inhibits beta-lactamase, protecting amoxicillin from enzymatic degradation and extending efficacy against resistant bacteria.
LOE Approaching
Approaching loss of exclusivity signals transition from growth to mature/generic phase; commercial teams should expect portfolio rebalancing and reduced headcount.
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.