NDAINJECTIONINJECTABLE
Approved
Dec 1986
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
5/8 — Partial
UNASYN (ampicillin sodium and sulbactam sodium) by Pfizer is clinical pharmacology general immediately after completion of a 15-minute intravenous infusion of ampicillin and sulbactam for injection, peak serum concentrations of ampicillin and sulbactam are attained. Approved for infections due to susceptible strains of the designated microorganisms in the conditions listed below, development of drug-resistant bacteria, maintain effectiveness of ampicillin and 5 more indications. First approved in 1986.
Drug data last refreshed 5h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
UNASYN is a fixed-dose combination of ampicillin sodium and sulbactam sodium administered by injection for treatment of bacterial infections caused by susceptible organisms. Sulbactam acts as a beta-lactamase inhibitor to protect ampicillin from enzymatic degradation and expand its spectrum against resistant pathogens. The combination achieves rapid peak serum concentrations with approximately 1-hour half-life and 75-85% urinary excretion in patients with normal renal function.
$0.093MPart D
LOE ApproachingDeclining
Mature product with minimal Part D uptake and approaching generics; limited team expansion anticipated as revenue contracts.
Mechanism of Action
CLINICAL PHARMACOLOGY General Immediately after completion of a 15-minute intravenous infusion of ampicillin and sulbactam for injection, peak serum concentrations of ampicillin and sulbactam are attained. Ampicillin serum levels are similar to those produced by the administration of equivalent…
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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.