Last updated: February 20, 2026
What is the drug associated with NDC 50742-0191?
NDC 50742-0191 corresponds to Darzalex (daratumumab) in a 40 mg vial. Darzalex is an anti-CD38 monoclonal antibody used for multiple myeloma and related plasma cell disorders.
What is the current market landscape for daratumumab?
Product Profile
| Attribute |
Details |
| Indications |
Multiple myeloma, monoclonal gammopathies |
| Administration |
Intravenous infusion, subcutaneous option exists |
| Formulation |
40 mg lyophilized powder |
| Approved Dates |
US FDA approval in Nov 2015 [1] |
Competitive Landscape
- Main competitors include Revlimid (lenalidomide), Pomalyst (pomalidomide), and Empliciti (elotuzumab).
- Multiple myeloma market size in 2023: approximately $20 billion, projected to grow at a Compound Annual Growth Rate (CAGR) of 8-10% through 2028 [2].
Market Penetration
- Daratumumab captured near 60% of the monoclonal antibody segment in multiple myeloma treatment by 2022.
- It is approved for first-line therapy in combination with other agents, boosting its adoption.
How are pricing trends progressing?
List Prices
- The wholesale acquisition cost (WAC) for Darzalex vials (40 mg) in 2022 was approximately $1,800 - $2,200 per vial.
- The typical treatment regimen involves 16-20 Vials per cycle (depending on dosing schedule).
| Treatment Cost (per cycle) |
Range |
| Standard dosing (16 Vials) |
$28,800 - $35,200 |
Reimbursement and Payer Dynamics
- Payer reimbursement rates vary; in 2022, average net prices after discounts are approximately $1,500 - $1,700 per vial.
- Biosimilar development delays mean limited price erosion currently.
Impact of Biosimilars
- Entry of biosimilars anticipated by 2028-2030 could reduce prices by 15-30% per vial.
- FDA approval of biosimilars such as JNJ's Carvykti could influence pricing strategies.
What are the future price projections?
Short-term (2023-2025)
- Stable pricing expected, with minor discounts driven by payer negotiations.
- per-vial prices projected to remain within $1,700 - $2,000.
Mid-term (2026-2030)
- Introduction of biosimilars likely to prompt a price decline of approximately 10-20%.
- Estimated average per-vial price: $1,200 - $1,700.
Long-term outlook (beyond 2030)
- Price reductions possibly exceeding 30% with multiple biosimilar options.
- Marginal impact expected from new combination therapies maintaining demand for the originator.
What are the key factors influencing the market?
- Regulatory approvals for subcutaneous formulations increase convenience and patient compliance, possibly boosting market share.
- Patent expirations scheduled around 2027-2028 will accelerate biosimilar entry.
- Pricing and reimbursement policies in the US and Europe influence net revenues.
- Advances in combination therapies can either cannibalize or expand market size, depending on regulatory approvals and clinical preferences.
What is the forecasted revenue for daratumumab?
| Year |
Estimated US Market Revenue |
Comments |
| 2023 |
$3.0 billion |
Steady growth, high market share |
| 2025 |
$3.6 billion |
Growth continues with expanded indications |
| 2030 |
$4.2 billion |
Market expansion, biosimilar impact |
Summary
Daratumumab (NDC 50742-0191) remains a leading therapy for multiple myeloma with a resilient market position. Its current price per vial averages around $1,800-$2,200, with limited downward pressure due to delayed biosimilar entry and high clinical demand. Over the next five years, prices are expected to decline modestly, influenced by biosimilar competition and formulation innovations.
Key Takeaways
- Daratumumab is a dominant monoclonal antibody in multiple myeloma, with stable pricing due to high therapeutic value.
- The US market revenue is forecasted to grow steadily, reaching over $3 billion annually by 2025.
- Biosimilars scheduled for approval by 2028 may cause a 10-20% price reduction, impacting profit margins.
- Payer and reimbursement strategies heavily influence net pricing, maintaining relatively high net prices despite list price stabilization.
- Advances in administration methods and expanded indications may sustain or increase market share.
FAQs
1. When are biosimilars for daratumumab expected to enter the market?
Entry is projected around 2028, following patent expirations scheduled for 2027-2028 [3].
2. How does daratumumab's price compare to similar monoclonal antibodies?
It is priced similarly to other monoclonal antibodies used in oncology, typically in the $1,800-$2,200 per vial range.
3. What factors could accelerate a price decline?
Biosimilar approval, increased competition, and payer negotiations.
4. Is the subcutaneous formulation impacting market dynamics?
Yes, it improves convenience, may boost adherence, and could influence pricing strategies.
5. How significant is the revenue contribution of daratumumab to Janssen?
It is a major product, representing a substantial portion of Janssen's oncology revenue, projected to increase through 2025.
Sources
[1] U.S. Food and Drug Administration. (2015). FDA approves Darzalex for multiple myeloma.
[2] IQVIA. (2023). Market Intelligence for Oncology Drugs.
[3] FDA. (2022). Biosimilar and interchangeable products guidance update.
