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 2d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SEPTRA is a fixed-dose combination of sulfamethoxazole and trimethoprim, a synergistic antibiotic used to treat bacterial and parasitic infections including UTIs, PCP prophylaxis, and certain respiratory infections. The drug works via sequential inhibition of bacterial folate synthesis: sulfamethoxazole inhibits dihydropteroate synthase while trimethoprim inhibits dihydrofolate reductase. It is rapidly absorbed orally with peak levels occurring 1–4 hours after administration and renal excretion as the primary elimination route.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%), suggesting the brand team is likely in defensive and generic-transition planning mode with potential workforce restructuring.
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.