NDAORALTABLET
Approved
May 1983
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH (sulfamethoxazole; trimethoprim) by Teva is clinical pharmacology sulfamethoxazole and trimethoprim is rapidly absorbed following oral administration. First approved in 1983.
Drug data last refreshed 3d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Sulfamethoxazole and trimethoprim (SMX-TMP) is a fixed-dose combination antibiotic that inhibits sequential steps in bacterial folate synthesis, providing synergistic bactericidal activity. It is administered orally as a tablet and used to treat a broad spectrum of bacterial infections including urinary tract infections, Pneumocystis jirovecii pneumonia (PCP), and other susceptible infections. The double-strength formulation (800 mg/160 mg) achieves therapeutic plasma concentrations within 1–4 hours, with peak levels maintained over 24 hours.
LOE Approaching
Product is in late-stage lifecycle with moderate competitive pressure (30%), signaling potential workforce restructuring and transition planning within the commercial organization.
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.