NDAORALSUSPENSION
Approved
May 1975
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
SEPTRA GRAPE (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 21h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SEPTRA GRAPE is a fixed-dose combination oral suspension of sulfamethoxazole and trimethoprim, a synergistic antibacterial agent that inhibits sequential steps in bacterial folate synthesis. It is indicated for treatment of urinary tract infections, Pneumocystis jirovecii pneumonia prophylaxis, and other bacterial infections caused by susceptible organisms. The drug is rapidly absorbed orally with peak levels 1–4 hours post-dose and exhibits dual metabolism via CYP2C9 and oxidative pathways.
LOE Approaching
Product lifecycle is in late mature/declining phase; commercial team is likely stabilized or consolidating, with minimal growth opportunities.
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.