NDAINJECTIONINJECTABLEPriority Review
Approved
Aug 1974
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
15
Data completeness
3/8 — Basic
Priority Review
DOXORUBICIN HYDROCHLORIDE (doxorubicin hydrochloride) by Pfizer is hydrochloride. First approved in 1974.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Doxorubicin hydrochloride is a small-molecule anthracycline chemotherapy agent approved in 1974 that works by binding to DNA and inhibiting nucleic acid synthesis, leading to rapid cell death. It is used across multiple cancer indications and is administered via injection. The drug induces mutagenesis and chromosomal aberrations, making it highly potent but requiring careful patient monitoring.
LOE Approaching
This legacy product is approaching loss of exclusivity with moderate competitive pressure (30/100), signaling a consolidating brand team focused on maintaining market position rather than growth initiatives.
Mechanism of Action
hydrochloride. The mechanism of action of doxorubicin hydrochloride is thought to be related to its ability to bind DNA and inhibit nucleic acid synthesis. Cell structure studies have demonstrated rapid cell penetration and perinuclear chromatin binding, rapid inhibition of mitotic activity and…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (15)
A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
Started Feb 2023
900 enrolled
Diffuse Large B-Cell Lymphoma
Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma
Started Mar 2022
80 enrolled
Advanced Soft-tissue SarcomaMetastatic Soft-tissue Sarcoma
A Phase 2 Clinical Study of Evaluation of Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection (609A) Combined With Doxorubicin Hydrochloride in the Treatment of Metastatic/Unresectable Non-specific Soft Tissue Sarcoma
Started Dec 2021
70 enrolled
Sarcoma, Soft Tissue
Pembrolizumab and Doxorubicin Hydrochloride or Anti-Estrogen Therapy in Treating Patients With Triple-Negative or Hormone Receptor-Positive Metastatic Breast Cancer
Started Mar 2016
30 enrolled
Estrogen Receptor NegativeEstrogen Receptor PositiveHER2/Neu Negative+4 more
Assess Bioequivalence of Two Formulations of Doxorubicin Hydrochloride Liposome in Female Patients With Ovarian Cancer
Started Sep 2014
30 enrolled
Ovarian Cancer
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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.