Last updated: February 25, 2026
What Is the Drug Associated With NDC 69367-0265?
The National Drug Code (NDC) 69367-0265 corresponds to Darzalex Faspro (daratumumab and hyaluronidase-fihj). This drug is a combination biologic used to treat multiple myeloma.
It was approved by the FDA in November 2020 for multiple myeloma indications, including relapsed or refractory disease, in combination with other agents. Darzalex Faspro combines the CD38-targeting monoclonal antibody daratumumab with hyaluronidase-fihj, facilitating subcutaneous administration.
Market Fundamentals
Patient Demographics and Demand Drivers
- Multiple myeloma prevalence: Estimated at 35,000 new cases annually in the US (American Cancer Society, 2022).
- Growth factors: Aging population, increased diagnosis rates, expanded indications.
- Treatment landscape: Darzalex Faspro competes primarily with other monoclonal antibodies like traditional daratumumab (subcutaneous formulation) and is positioned as a convenient subcutaneous option.
Market Size and Penetration
| Parameter |
Value |
| US multiple myeloma patients |
35,000 (annual new cases) |
| Market penetration (2022 estimate) |
~25% (initial adoption among eligible patients) |
| Total addressable patients (eligible, relapsed/refractory) |
Approx. 15,000–20,000 in US |
Global demand remains limited but is growing with patent exclusivity and expanded indication approval.
Competitive Landscape
| Key Competitor |
Indication(s) |
Pricing Strategy |
| Subcutaneous daratumumab (Darzalex Faspro) |
Multiple myeloma |
Similar dosing, price parity or slight premium for convenience |
| Isatuximab (Re Myeloma) |
Multiple myeloma |
Similar biologic class, lower adoption in US initially |
| Carfilzomib-based regimens |
Multiple myeloma |
Different class, competing on efficacy and cost |
The availability of a subcutaneous formulation has begun to shift prescribing behaviors towards Darzalex Faspro.
Price Analysis and Projections
Current Pricing Environment
- Average wholesale price (AWP): Approximately $4,800 per 20 mg vial.
- Typical treatment dose: 1800 mg (90 mL) per cycle (four weekly doses, then monthly maintenance).
- Per cycle cost: Estimated at $18,000 to $22,000, depending on dosing adjustments and patient factors.
- Reimbursement considerations: Payer negotiations influence net prices; US Medicare and private insurers generally negotiate discounts, reducing the effective price.
Historical Price Trends
- Daratumumab (original IV formulation): Initially priced around $5,000 per infusion.
- Darzalex Faspro introduced at a slightly reduced AWP (~$4,800), emphasizing the convenience of subcutaneous delivery.
- Price stability observed since launch in 2020; no significant discounts or price reductions recorded yet.
Price Projections (2023–2027)
| Year |
Estimated Per Cycle Price |
Notes |
| 2023 |
$18,500 – $20,000 |
Stable pricing, potential negotiations reduce net cost |
| 2024 |
$19,000 – $21,000 |
Slight inflation, introduction of biosimilars unlikely before 2025 |
| 2025 |
$19,000 – $22,000 |
Biosimilar entry not expected; price stability maintained |
| 2026 |
$19,500 – $22,500 |
Market maturation, seasonal variations |
| 2027 |
$20,000 – $23,000 |
Potential inflation, further payer discounts |
Price Sensitivity and Cost-Effectiveness
- Price elasticity is relatively low due to FDA approval, indication exclusivity, and lack of direct biosimilar competition.
- Cost-effectiveness studies favor the drug when factoring in improved quality of life and convenience versus IV formulations.
- Reimbursement pressure and payer negotiations are likely to cap net prices increases.
Regulatory and Policy Impact
- No biosimilar approval for daratumumab as of 2023.
- Policy trends favor biosimilars for biologics, potentially impacting pricing after 2025.
- Market access and coverage policies could influence real-world prices, especially for outpatient administration settings.
Summary and Forward Outlook
Daratumumab-based therapies hold a stable position in multiple myeloma treatment. Prices are expected to remain constant with slight increases through 2027, supported by demand and limited biosimilar competition. Payer negotiations and policy shifts could modify the trajectory slightly but are unlikely to materially lower prices before 2025.
Key Takeaways
- NDC 69367-0265 (Daratumumab and Hyaluronidase-fihj) is a key player in multiple myeloma treatment.
- US market size is approximately 15,000–20,000 patients eligible annually for this therapy.
- Current treatment cycle prices range from $18,500 to $20,000, with stable projections through 2027.
- Biosimilar competition is unlikely before 2025, maintaining current pricing trends.
- Payer negotiations and policy changes could alter net prices but likely won’t cause drastic shifts soon.
FAQs
1. When is a biosimilar for daratumumab expected?
Biosimilar approval for daratumumab in the US is not yet filed; industry projections suggest potential entry around 2025–2026.
2. How does Darzalex Faspro compare cost-wise to IV formulations?
While priced similarly at the AWP level, Faspro’s convenience may reduce healthcare resource utilization, potentially lowering overall treatment costs.
3. What factors could influence prices before 2027?
Introduction of biosimilars, negotiated discounts, policy reforms, and competition from novel agents could impact prices.
4. How does the market trend look for multiple myeloma therapies?
The market continues to expand with evolving treatment combinations, older patient populations, and increased diagnosis rates.
5. What is the main driver for demand increase?
Advances in indications, improved patient tolerability, and physician preference for subcutaneous administration are primary drivers.
References
[1] American Cancer Society. (2022). Cancer Facts & Figures 2022.
[2] U.S. Food and Drug Administration. (2020). FDA approves Darzalex Faspro to treat multiple myeloma.
[3] IQVIA. (2022). Pharmaceutical Market Data.
[4] CMS.gov. (2023). Medicare Physician Fee Schedule.
[5] FDA. (2022). Biosimilar Development and Approvals.
