DOXORUBICIN HYDROCHLORIDE

Post-LOE

doxorubicin hydrochloride

Viatris (2)

ANDAINJECTIONINJECTABLE

Approved

Oct 2011

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

DOXORUBICIN HYDROCHLORIDE (doxorubicin hydrochloride) by Viatris (2) is doxorubicin. Approved for breast cancer, breast cancer, leukemia and 1 more indications. First approved in 2011.

Drug data last refreshed 18h ago

Mechanism of Action

doxorubicin. Intercalation inhibits nucleotide replication and action of DNA and RNA polymerases. The interaction of doxorubicin with topoisomerase II to form DNA-cleavable complexes appears to be an important mechanism of doxorubicin hydrochloride cytocidal activity.

Indications (3)

breast cancer leukemia lymphoma

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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.

Clinical Trials (15)

NCT05578976Phase 3Active Not Recruiting

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

NCT04874311Phase 2Recruiting

Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma

Started Mar 2022

80 enrolled

Advanced Soft-tissue SarcomaMetastatic Soft-tissue Sarcoma

NCT05138146Phase 2Unknown

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

NCT02648477Phase 2Completed

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

NCT02237690Phase 1Completed

Assess Bioequivalence of Two Formulations of Doxorubicin Hydrochloride Liposome in Female Patients With Ovarian Cancer

Started Sep 2014

30 enrolled

Ovarian Cancer