NDAORALTABLETPriority Review
Approved
Jul 1973
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
Priority Review
SEPTRA DS (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 DS is a fixed-dose combination of sulfamethoxazole and trimethoprim, two synergistic antibacterial agents that inhibit sequential steps in bacterial folate synthesis. It is indicated for treatment of urinary tract infections, acute otitis media, and Pneumocystis pneumonia prophylaxis, among other infections. The drug is rapidly absorbed orally, with peak levels achieved within 1-4 hours and a mean serum half-life of 8-10 hours for both components.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30%), signaling potential team restructuring and transition to generic support or line extension strategy.
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.