NDAINJECTIONINJECTABLEPriority Review
Approved
Nov 1992
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
3/8 — Basic
Priority Review
ALKERAN (melphalan hydrochloride) by Hetero is clinical pharmacology: melphalan is an alkylating agent of the bischloroethylamine type. First approved in 1992.
Drug data last refreshed 13h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALKERAN (melphalan hydrochloride) is a bifunctional alkylating agent that induces interstrand DNA cross-linking, making it cytotoxic to both resting and rapidly dividing tumor cells. It is primarily indicated for multiple myeloma treatment. The drug works by binding to guanine residues in DNA, disrupting cell replication and inducing apoptosis.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); brand team likely transitioning to lifecycle extension or preparing for generic erosion.
Mechanism of Action
CLINICAL PHARMACOLOGY: Melphalan is an alkylating agent of the bischloroethylamine type. As a result, its cytotoxicity appears to be related to the extent of its interstrand cross-linking with DNA, probably by binding at the Nposition of guanine. Like other bifunctional alkylating agents, it is…
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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.