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 2d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Septra is a fixed-dose combination antibiotic containing sulfamethoxazole and trimethoprim, used to treat bacterial infections including urinary tract infections, Pneumocystis pneumonia prophylaxis, and other susceptible gram-positive and gram-negative infections. The drug works synergistically by inhibiting sequential steps in bacterial folate metabolism—sulfamethoxazole inhibits dihydropteroate synthase while trimethoprim inhibits dihydrofolate reductase—resulting in bactericidal activity. Both components are rapidly absorbed orally, achieve therapeutic concentrations in blood and urine within 1-4 hours, and are primarily eliminated renally.
LOE Approaching
Septra faces moderate competitive pressure (30/100) with LOE approaching, indicating a product in maintenance/defense phase requiring lean commercial operations and focused brand stewardship.
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.