NDAINJECTIONINJECTABLE
Approved
Jun 1981
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
SEPTRA (sulfamethoxazole; trimethoprim) by Monarch Therapeutics is clinical pharmacology sulfamethoxazole and trimethoprim is rapidly absorbed following oral administration. First approved in 1981.
Drug data last refreshed 22h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SEPTRA is a fixed-dose combination antibiotic containing sulfamethoxazole and trimethoprim, approved in 1981 for bacterial infections. It works through synergistic inhibition of bacterial folate synthesis, with both components rapidly absorbed and primarily renally excreted. The drug is indicated for urinary tract infections, certain respiratory infections, and other susceptible bacterial conditions.
LOE Approaching
As a legacy product approaching loss of exclusivity with low competitive pressure (30%), SEPTRA teams are likely focused on cost management and generic transition planning rather than growth initiatives.
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.