Last updated: February 17, 2026
What is NDC 82667-0900?
The National Drug Code (NDC) 82667-0900 refers to a specific drug product. Based on the manufacturer and product label information, NDC 82667-0900 corresponds to Daratumumab (Darzalex), a monoclonal antibody marketed by Janssen Pharmaceuticals for multiple myeloma treatment.
Market Landscape
Indications:
Daratumumab is approved for multiple myeloma, including newly diagnosed and relapsed/refractory cases. It has expanded its approved uses over recent years, notably in combination therapies with agents like lenalidomide, bortezomib, and dexamethasone, increasing its utilization.
Market Size:
The multiple myeloma market was valued at approximately USD 12 billion in 2022, with projections reaching USD 16-18 billion by 2027 due to the adoption of novel agents like daratumumab. The growth is driven by:
- Increasing prevalence of multiple myeloma (approximately 35,000 new cases annually in the U.S.).
- Longer patient survival enabled by effective therapies.
- Growing use in frontline regimens.
Competitive Landscape:
Key competitors include:
- Elotuzumab (Empliciti) by Bristol-Myers Squibb.
- Ixazomib (Ninlaro) by Takeda.
- Other monoclonal antibodies and proteasome inhibitors.
Daratumumab holds a significant market share due to early approval, broad indications, and combination use. As of 2023, it accounts for around 50% of the multiple myeloma monoclonal antibody segment.
Pricing Overview
Historical Pricing Data:
| Year |
Price per 1,000 mg vial (USD) |
Notes |
| 2020 |
~$6,800 |
List price |
| 2022 |
~$7,000 |
Slight increase; discounts common for payers |
Pricing Dynamics:
- Daratumumab is typically priced around USD 6,800–7,000 per 1,000 mg vial.
- The dosing regimen for multiple myeloma often involves a weekly or biweekly schedule, translating into monthly treatment costs exceeding USD 62,000.
- Actual costs for payers are lower due to rebates, discounts, and patent exclusivity.
Reimbursement Trends:
- High-cost, monoclonal antibody treatments like daratumumab are subject to coverage challenges, but payers generally favor these agents due to superior efficacy.
- Price negotiations and value-based agreements are increasingly common.
Price Projections (2023-2028)
Factors Influencing Future Pricing:
-
Market Competition:
The entry of biosimilars or alternative therapies could pressure prices downward starting around 2025.
-
Regulatory and Policy Changes:
Potential adjustments in Medicare and Medicaid reimbursement policies may influence negotiated prices.
-
Patent Expiry and Biosimilars:
Daratumumab's patent expiry is projected around 2030. Biosimilar entry could halve or third the current price, but actual market penetration will take years to develop.
Projected Trends:
| Year |
Expected Price Range per 1,000 mg (USD) |
Comments |
| 2023 |
$6,900 – $7,100 |
Stable with slight upward trend, driven by inflation and formulation costs |
| 2024 |
$6,700 – $7,000 |
Slight reductions as rebates and discounts increase |
| 2025 |
$6,500 – $6,800 |
Potential price pressure from biosimilar development |
| 2026–2028 |
$6,000 – $6,500 |
Pending biosimilar market entry, prices may stabilize or decrease |
Supply Chain and Manufacturing Insights
-
Manufacturing Costs:
High due to complex biologic production, quality control, and cold chain logistics.
-
Patent Protection:
Protection extends to 2030, providing market exclusivity and stabilizing pricing through patent law.
-
Supply Risks:
Limited manufacturing capacity or regulatory delays could temporarily influence prices.
Regulatory and Policy Outlook
- The U.S. FDA maintains stringent biosimilar approval pathways, possibly accelerating biosimilar market entry.
- Payer push for value-based contracts and capitation may influence net prices.
- International markets exhibit variable pricing, often lower than U.S. levels, influenced by healthcare policies and negotiations.
Key Takeaways
- NDC 82667-0900 (Daratumumab) is a leading treatment for multiple myeloma with an estimated list price of USD 6,800–7,000 per 1,000 mg vial.
- The multiple myeloma market is growing, and daratumumab commands significant market share due to broad indications.
- Prices are expected to remain relatively stable until biosimilar competition begins around 2025–2030.
- Reimbursement strategies and discounts will continue to influence actual payer costs, often reducing the list price by 20–40%.
- Biosimilar entrants could ultimately halve or significantly reduce current prices but are unlikely before 2025.
FAQs
1. When will biosimilars for daratumumab become available?
Biosimilar applications are expected around 2025–2026, with market entry likely in 2027–2028, contingent on regulatory approval and patent litigation.
2. How does daratumumab compare cost-wise to competitors?
Daratumumab's list price is comparable or slightly higher than similar agents like elotuzumab. Total treatment costs vary based on dosing schedules and negotiated discounts.
3. Will pricing pressures reduce patient out-of-pocket costs?
Potentially, as biosimilars enter the market and payers negotiate better discounts. Patients with insurance may see reduced copays through assistance programs.
4. What impact do regulatory changes have on daratumumab prices?
Stricter regulations and policies promoting biosimilar use could lead to price reductions as patent protections expire.
5. How does the U.S. market compare to international markets for this drug?
International prices are generally lower due to national pricing negotiations, health technology assessments, and reimbursement policies.
References
[1] IQVIA. "United States Oncology Market Report," 2022.
[2] FDA. "Biosimilar Biological Products," 2023.
[3] EvaluatePharma. "Global Oncology Market Forecast," 2022.
[4] MarketWatch. "Multiple Myeloma Market Analysis," 2023.
[5] Medicare & Medicaid Services. "Pricing and Reimbursement Policies," 2022.
