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 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Daunorubicin hydrochloride is a cytotoxic anthracycline chemotherapy agent that works by intercalating into DNA and inhibiting topoisomerase II, causing single and double-strand breaks. It is used primarily in acute leukemias and lymphomas. The drug undergoes rapid tissue distribution with active metabolite formation and hepatic metabolism.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%) suggests defensive positioning and transition planning within commercial teams.
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.