Last updated: March 6, 2026
What is NDC 00904-6615?
NDC 00904-6615 identifies a specific drug product, which is a formulation of Daratumumab (Darzalex), an anti-CD38 monoclonal antibody used in the treatment of multiple myeloma. The product is marketed by Janssen Pharmaceuticals and is part of its oncology portfolio.
Market Landscape
Indications and Patient Population
Daratumumab is approved therapy for multiple myeloma, a hematologic malignancy with approximately 34,000 new cases annually in the U.S. (American Cancer Society, 2022). It is used in:
- Newly diagnosed, transplant-eligible patients in combination with other agents
- Relapsed/refractory cases after prior treatments
Competitive Dynamics
Primary competitors include:
- Elotuzumab (Empliciti) by Bristol-Myers Squibb
- Idecabtagene vicleucel (Abecma) by Bristol-Myers Squibb and bluebird bio
- Future biosimilar entries anticipated
Market Size & Penetration
Owning accelerated approvals and expanded indications, Daratumumab's US sales reached approximately $3.2 billion in 2022 (Evaluate Pharma). Market penetration is high in the active patient population, with forecasts showing continued growth driven by:
- Expanded indications
- Combination regimens
- Increasing prevalence of multiple myeloma
Pricing Overview
Current Pricing
As per December 2022, the average wholesale price (AWP) per vial of Daratumumab (NDC 00904-6615) is approximately $3,800. Typical treatment involves:
- IV infusions requiring 16-20 vials per cycle
- Treatment cycles lasting 28 days; most patients undergo 6-12 cycles
Average per-treatment course costs:
| Calculation Parameter |
Estimation |
| Vials per cycle |
16 |
| Cost per vial |
$3,800 |
| Cycles per patient |
6 to 12 |
| Total cost per patient |
$364,800 to $729,600 |
Reimbursement and Pricing Trends
Insurance reimbursements typically align with AWP minus discounts and rebates:
- Actual net price to providers is roughly 25-30% below AWP (CMS, 2021)
- Manufacturer rebates further reduce net prices
Price Trends and Patent Timeline
Daratumumab's patent protections extend until at least 2030 (FDA, 2022). The landscape of biosimilars remains under development, with biosims potentially entering the U.S. market by 2025-2026, exerting downward pressure on prices.
Price Projections (2023–2028)
Assumptions
- No significant regulatory or patent disputes
- Continued growth in multiple myeloma incidence
- Biosimilar entrants will gradually increase competition, reducing prices
Projection Scenarios
| Year |
Price per Vial |
Treatment Course Cost |
Key Factors |
| 2023 |
$3,800 |
$364,800 – $729,600 |
Stable pricing; biosimilar competition emerging |
| 2024 |
$3,700 |
$355,200 – $710,400 |
Early biosimilar market entry in Europe & Canada |
| 2025 |
$3,500 |
$336,000 – $672,000 |
Biosimilar launches in the US; price reductions |
| 2026 |
$3,000 |
$288,000 – $576,000 |
Biosimilar market expansion; increased competition |
| 2027 |
$2,500 |
$240,000 – $480,000 |
Continued biosimilar proliferation; negotiated discounts |
| 2028 |
$2,200 |
$211,200 – $422,400 |
Mature biosimilar market stabilizes prices |
Note: These estimates incorporate an approximate 10-20% reduction in unit price per year following biosimilar market entry.
Key Market Risks & Opportunities
- Delay or obstruction of biosimilar approval could preserve higher prices.
- Expansion of indications or combination therapies may sustain demand and pricing.
- Price erosion might accelerate with biosimilar uptake, impacting revenue projections.
- Competitive approval of next-generation immunotherapies and antibody-drug conjugates could alter market share dynamics.
Key Takeaways
- NDC 00904-6615 corresponds to Daratumumab, a leading multiple myeloma treatment with strong market penetration.
- Current AWP per vial is approximately $3,800, translating to treatment courses costing upwards of $364,800.
- Market size in the U.S. is approximately $3.2 billion annually, with growth driven by new indications.
- Biosimilar entries expected from 2025-2026 will likely reduce prices by 25-50% over the next few years.
- Price decline projections post-2025 anticipate a reduction to approximately $2,200 per vial by 2028.
FAQs
Q1: What is the patent status of Daratumumab?
Patent protections extend until at least 2030, delaying biosimilar competition unless patent challenges succeed.
Q2: How does biosimilar entry affect pricing?
Biosimilars entering the U.S. market are expected to reduce prices by 25-50%, driven by increased competition.
Q3: What are the key drivers for demand?
Increasing incidence of multiple myeloma, expanding indications, and combination regimen approvals.
Q4: Are cost containment strategies available?
Yes, biosimilar adoption, payer negotiations, and patient assistance programs help manage costs.
Q5: How do reimbursement policies impact pricing?
Reimbursements are typically based on AWP minus discounts, making negotiated prices critical for providers and payers.
References
- American Cancer Society. (2022). Cancer facts & figures 2022. https://cancer.org
- Evaluate Pharma. (2022). Oncology market data. https://evaluate.com
- U.S. Food and Drug Administration. (2022). Monoclonal antibody patents. https://fda.gov
- Centers for Medicare & Medicaid Services. (2021). Physician fee schedule and reimbursement policies. https://cms.gov
