NDAORALSUSPENSION
Approved
Apr 1975
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
BACTRIM PEDIATRIC (sulfamethoxazole; trimethoprim) by PharmaIN is clinical pharmacology sulfamethoxazole and trimethoprim is rapidly absorbed following oral administration. First approved in 1975.
Drug data last refreshed 23h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Bactrim Pediatric is a fixed-dose combination of sulfamethoxazole and trimethoprim, a synergistic antibiotic indicated for pediatric bacterial infections. The drug works through dual inhibition of bacterial folate synthesis—sulfamethoxazole inhibits dihydropteroate synthase while trimethoprim inhibits dihydrofolate reductase—creating sequential blockade of nucleotide synthesis. It is formulated as an oral suspension for convenient pediatric dosing.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30% intensity), suggesting defensive positioning and potential cost-containment focus for remaining brand portfolio value.
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.