FLUDARA
LOE ApproachingNDAINJECTIONINJECTABLEPriority Review
Approved
Apr 1991
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
FLUDARA by Sanofi is clinical pharmacology fludarabine phosphate is rapidly dephosphorylated to 2-fluoro-ara-a and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2-fluoro-ara-atp. Approved for whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. First approved in 1991.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FLUDARA (fludarabine phosphate) is an intravenous antimetabolite that inhibits DNA synthesis by blocking DNA polymerase alpha, ribonucleotide reductase, and DNA primase. It is indicated for chronic lymphocytic leukemia (CLL) patients whose disease has progressed despite prior alkylating-agent therapy. The drug is rapidly converted to its active metabolite 2-fluoro-ara-A, which accumulates over a 5-day treatment cycle with a terminal half-life of approximately 20 hours.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%); expect team restructuring and focus on cost management and market defense.
Mechanism of Action
CLINICAL PHARMACOLOGY Fludarabine phosphate is rapidly dephosphorylated to 2-fluoro-ara-A and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2-fluoro-ara-ATP. This metabolite appears to act by inhibiting DNA polymerase alpha, ribonucleotide reductase and DNA…
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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.