NDAINJECTIONINJECTABLE
Approved
Jan 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
DAUNORUBICIN HYDROCHLORIDE (daunorubicin hydrochloride) by Hikma is clinical pharmacology mechanism of action daunorubicin has antimitotic and cytotoxic activity through a number of proposed mechanisms of action. First approved in 1998.
Drug data last refreshed 22h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Daunorubicin hydrochloride is a cytotoxic anthracycline chemotherapy agent that intercalates into DNA and inhibits topoisomerase II, inducing DNA strand breaks and cell death. It is used to treat hematologic malignancies, primarily acute leukemias and lymphomas. The drug works through multiple mechanisms including DNA intercalation, topoisomerase II inhibition, polymerase inhibition, and free radical generation.
LOE Approaching
Product lifecycle is approaching loss of exclusivity with moderate competitive pressure (30), signaling potential team restructuring and transition focus toward defending market share.
Mechanism of Action
CLINICAL PHARMACOLOGY Mechanism of Action Daunorubicin has antimitotic and cytotoxic activity through a number of proposed mechanisms of action. Daunorubicin forms complexes with DNA by intercalation between base pairs. It inhibits topoisomerase II activity by stabilizing the DNA-topoisomerase II…
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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.