NDAINTRAVENOUSSOLUTION
Approved
Aug 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
2
Data completeness
5/8 — Partial
IVRA (melphalan hcl) by Apotex is type. First approved in 2023.
Drug data last refreshed 3h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IVRA (Melphalan HCl) is an intravenous bifunctional alkylating agent approved in August 2023 for cancer treatment. It exerts cytotoxicity by forming interstrand cross-links with DNA at the guanine N-position, making it active against both resting and rapidly dividing tumor cells. The drug is indicated for oncology patients requiring systemic chemotherapy.
Peak9.7 years to LOE
Product is in peak commercial phase post-launch with competitive pressure currently minimal, suggesting stable team sizing and commercial infrastructure investment.
Mechanism of Action
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 N position of guanine. Like other bifunctional alkylating agents, it is active against both resting and rapidly dividing tumor cells.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
Evaluate Safety and Efficacy of High-dose Melphalan HCL for Injection in MM Patients With Auto-HSC Transplantation
Started Jul 2020
67 enrolled
Multiple Myeloma
PK Study of Melphalan HCL & Alkeran for Injection of MA Conditioning in MM Patients of Autologous Transplantation
Started Jan 2010
24 enrolled
Multiple Myeloma
Career Relevance
IVRA offers a rare opportunity to build a commercial franchise around a novel formulation with no current competition and a long patent runway. Teams on this product will focus on market development, oncology relationship building, and label expansion strategy with substantial runway before generic entry.
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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.