NDAORALTABLETPriority Review
Approved
Jul 1973
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
Priority Review
SEPTRA (sulfamethoxazole; trimethoprim) by Monarch Therapeutics is clinical pharmacology sulfamethoxazole and trimethoprim is rapidly absorbed following oral administration. First approved in 1973.
Drug data last refreshed 15h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SEPTRA is a fixed-dose oral combination of sulfamethoxazole and trimethoprim, a synergistic antibiotic effective against a broad spectrum of bacterial pathogens. The two components work via sequential inhibition of bacterial folate synthesis: sulfamethoxazole inhibits dihydropteroate synthase while trimethoprim inhibits dihydrofolate reductase. It is commonly used to treat urinary tract infections, Pneumocystis jirovecii pneumonia, and other susceptible infections.
LOE Approaching
Product is in late-stage lifecycle with moderate competitive pressure (score: 30/100), indicating reduced growth opportunities and team contraction risk.
Mechanism of Action
CLINICAL PHARMACOLOGY Sulfamethoxazole and trimethoprim is rapidly absorbed following oral administration. Both sulfamethoxazole and trimethoprim exist in the blood as unbound, protein-bound and metabolized forms; sulfamethoxazole also exists as the conjugated form. Sulfamethoxazole is metabolized…
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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.