NDAORALTABLET
Approved
May 1980
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
PROLOPRIM (trimethoprim) by Monarch Therapeutics is dihydrofolate reductase inhibitors [moa]. First approved in 1980.
Drug data last refreshed 19h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROLOPRIM (trimethoprim) is an oral tablet dihydrofolate reductase inhibitor approved in 1980 for bacterial infections. It works by inhibiting bacterial dihydrofolate reductase, disrupting folate metabolism and blocking DNA synthesis. This small-molecule antibiotic is used as monotherapy or in combination regimens for urinary tract and other susceptible infections.
LOE Approaching
As an older generic approaching loss of exclusivity with moderate competitive pressure (30%), career growth on this brand is limited; team focus shifts from growth to margin defense and retention.
Mechanism of Action
Dihydrofolate Reductase Inhibitors
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Trimethoprim/Sulfamethoxazole Combined With Caspofungin as First-line Therapy in PCP
Started Aug 2019
122 enrolled
Pneumocystis Pneumonia
Short and Long Term Outcomes of Doxycycline Versus Trimethoprim-Sulfamethoxazole for Skin and Soft Tissue Infections Treatment
Started Nov 2018
269 enrolled
Methicillin-resistant Staphylococcus AureusSkin Infection
PK of Clindamycin and Trimethoprim-sulfamethoxazole in Infants and Children
Started Nov 2015
51 enrolled
Bacterial Infections
Drug-drug Interaction Study of GSK1278863 With Pioglitazone, Rosuvastatin and Trimethoprim in Healthy Adult Volunteers
Started Feb 2015
70 enrolled
Anaemia
Daily Trimethoprim-sulfamethoxazole or Weekly Chloroquine Among Adults on ART in Malawi
Started Nov 2012
1,499 enrolled
HIV
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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.