NDAINTRAVENOUSSOLUTION
Approved
Dec 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
11
Data completeness
7/8 — Comprehensive
BENDEKA (bendamustine hydrochloride) by Eagle Pharmaceuticals is purine-like benzimidazole ring. Approved for non-hodgkin's lymphoma, follicular lymphoma, mantle cell lymphoma and 1 more indications. First approved in 2015.
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BENDEKA is a bifunctional alkylating agent containing bendamustine hydrochloride administered intravenously for hematologic malignancies. It forms interstrand DNA crosslinks leading to cell death in both quiescent and dividing cells. The product treats 11 indications spanning non-Hodgkin's lymphoma, chronic lymphocytic leukemia, Hodgkin lymphoma, and multiple myeloma.
$3MPart D
Peak6.9 years to LOEProduct is in peak revenue phase with modest Part D spending suggesting niche positioning in hematologic oncology with small sales team requirements.
Mechanism of Action
purine-like benzimidazole ring. Mechlorethamine and its derivatives form electrophilic alkyl groups. These groups form covalent bonds with electron-rich nucleophilic moieties, resulting in interstrand DNA crosslinks. The bifunctional covalent linkage can lead to cell death via several pathways.…
Indications (4)
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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.