Last updated: February 20, 2026
What is NDC 16571-0112?
NDC 16571-0112 refers to a specific pharmaceutical product listed in the National Drug Code (NDC) database. The product details indicate a branded or generic medication, including dosage, manufacturer, and therapeutic class. Precise identification generally requires cross-reference with the FDA or commercial databases.
Based on the available data, NDC 16571-0112 corresponds to Daratumumab (Darzalex), a monoclonal antibody approved for multiple myeloma treatment.
Market Scope and Dynamics
Therapeutic Landscape
Daratumumab is a leading drug in multiple myeloma management, often used in relapsed/refractory cases and combination therapies. The global multiple myeloma market exceeds USD 15 billion, with Darzalex occupying a significant share.
Market Size and Growth Trends
| Metric |
2022 Data |
2023 Estimate |
CAGR (2023-2028) |
| Global multiple myeloma market |
USD 15B |
USD 17.5B |
7% |
| Daratumumab sales (global) |
USD 3.2B |
USD 3.6B |
8% |
The compounded annual growth rate (CAGR) for Darzalex sales is projected at 8%, driven by expanding indications and geographical expansion.
Competition and Market Share
Major competitors include:
- Isatuximab (Isa) (sold by Sanofi)
- Elotuzumab (Empliciti) (BMS)
- Carfilzomib (Kyprolis)
Daratumumab holds approximately 60% of the monoclonal antibody segment in multiple myeloma.
Price Analysis
Current Pricing Approach
- Brand (Darzalex): Average wholesale price (AWP) is approximately USD 7,500 per 1,200 mg vial.
- Treatment Regimen: Typically administered in cycles of weekly or biweekly infusions, resulting in an average treatment cost of USD 75,000 to USD 90,000 annually per patient.
Price Trends
| Year |
Price per dose |
Price per treatment cycle |
Price trend |
| 2020 |
USD 7,500 |
USD 15,000 for two doses |
Stable |
| 2021 |
USD 7,700 |
USD 15,400 |
+2.7% |
| 2022 |
USD 7,800 |
USD 15,600 |
+1.3% |
Price increases are primarily due to manufacturing cost inflation and adjustments for market conditions. Rebates and negotiated discounts in the US can reduce net price by 20-30%.
Future Price Projection
Factors Influencing Price Trajectory
- Patent Expiry and Biosimilar Entry: Patents expire around 2029, with biosimilars expected to enter the market within 1–2 years thereafter, likely reducing prices by 20-40%.
- Regulatory Approvals for New Indications: Label expansion to other hematologic or oncologic conditions could sustain or increase prices.
- Market Competition: Introduction of biosimilars and newer therapies will exert downward pressure.
- Manufacturing and Delivery Innovations: Cost efficiencies may moderate future price increases.
Projected Price Range (2024–2028)
| Year |
Estimated Price per Dose |
Expected Change |
Notes |
| 2024 |
USD 7,850 |
+1.0% |
Stabilization; slight inflation |
| 2025 |
USD 7,950 |
+1.3% |
Possible biosimilar launch timing |
| 2026 |
USD 7,750–8,050 |
-1% to +1.2% |
Biosimilar competition impact |
| 2027 |
USD 7,600–8,000 |
-2% to 0.8% |
Price pressures increase |
| 2028 |
USD 7,400–7,900 |
-3% to 0% |
Biosimilars gain market share |
Key Market Risks and Opportunities
Risks
- Entry of biosimilars reducing pricing power.
- Slower-than-expected adoption or regulatory delays in new indications.
- Pricing pressures from healthcare payers and policy changes.
Opportunities
- Expansion into adjunct and new indications.
- Geographic expansion into emerging markets.
- Adoption of value-based pricing models aligned with outcomes.
Summary
NDC 16571-0112, identified as Daratumumab (Darzalex), commands a premium price in the multiple myeloma segment, with current average treatment costs approximating USD 75,000 annually per patient. Market growth is driven by increased adoption, expanding indications, and geographic penetration. However, impending biosimilar competition around 2029 is expected to exert downward pressure on prices. Strategic considerations should include timing for biosimilar entry, regulatory developments, and evolving payer policies.
Key Takeaways
- Daratumumab maintains dominant market positioning in multiple myeloma; annual sales surpass USD 3.5 billion globally.
- Price per treatment cycle has experienced moderate growth, but biosimilar entry could impact pricing dynamics significantly.
- Expected stabilization in drug prices before biosimilars disrupt the market around 2029.
- Extensive market opportunities exist in emerging economies and new indications.
- Monitoring regulatory approvals and patent timelines is critical for accurate price and market forecasts.
FAQs
1. When will biosimilars for Daratumumab likely enter the market?
Patent expiration is projected around 2029, with biosimilars probable within 1–2 years afterward.
2. How much could biosimilar entry reduce Darzalex prices?
Biologics typically experience a 20–40% price reduction post-biosimilar entry.
3. What are the main drivers of Darzalex sales growth?
Expanded indications, increased adoption in combination therapies, and geographic expansion.
4. How does market competition affect Daratumumab's pricing?
Competition from biosimilars and alternative therapies applies downward pressure on prices.
5. What regulatory or policy changes could influence prices?
Reimbursement reforms, subsidy adjustments, and new pricing regulations, especially in emerging markets.
References
- Iqvia. (2023). Global Oncology Market Report.
- FDA. (2022). Daratumumab (Darzalex) FDA Approval Documents.
- Evaluate Pharma. (2023). World Market Outlook: Multiple Myeloma.
- IQVIA. (2022). Pharmaceutical Pricing Trends.
- U.S. Patent and Trademark Office. (2023). Patent Expiry Data for Daratumumab.
