NDAORALSUSPENSION
Approved
May 1975
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 1975.
Drug data last refreshed 14h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SEPTRA is a fixed-dose combination oral suspension containing sulfamethoxazole and trimethoprim, a synergistic dual-mechanism antibiotic used to treat bacterial infections including urinary tract infections, otitis media, and opportunistic infections. Both components inhibit sequential steps in bacterial folate metabolism, with sulfamethoxazole inhibiting dihydropteroate synthase and trimethoprim inhibiting dihydrofolate reductase. The combination is rapidly absorbed orally, achieving peak blood levels 1–4 hours after administration with mean half-lives of 10 hours (sulfamethoxazole) and 8–10 hours (trimethoprim).
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30% intensity), suggesting consolidation of brand team and transition toward generic stewardship or portfolio repositioning roles.
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.