NDAINJECTIONINJECTABLEPriority Review
Approved
Nov 1959
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
CYTOXAN (LYOPHILIZED) (cyclophosphamide) by Baxter is characterized. Approved for breast cancer, lymphoma, leukemia and 2 more indications. First approved in 1959.
Drug data last refreshed 1w ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CYTOXAN (cyclophosphamide) is a classic alkylating agent chemotherapy approved in 1959 that works by cross-linking tumor cell DNA to interfere with malignant cell proliferation. It is indicated for breast cancer, lymphoma, leukemia, multiple myeloma, and idiopathic membranous nephropathy. The drug is administered by injection and represents a foundational chemotherapy backbone across multiple hematologic and solid tumor indications.
LOE Approaching
As a mature product approaching loss of exclusivity with moderate competitive pressure (30/100), commercial teams are focused on lifecycle management and defending market share against newer targeted therapies rather than growth initiatives.
Mechanism of Action
characterized. However, cross-linking of tumor cell DNA may be involved. The active alkylating metabolites of cyclophosphamide interfere with the growth of susceptible rapidly proliferating malignant cells.
Indications (5)
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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.