Last updated: July 27, 2025
Introduction
NDC 16571-0692 represents a specific pharmaceutical product registered within the U.S. National Drug Code (NDC) system. To provide a comprehensive market analysis and price projection, it is essential to identify the drug's active ingredient, therapeutic class, current market dynamics, regulatory environment, and competitive landscape. This report offers a detailed examination to assist stakeholders in strategic planning, investment, and operational decisions.
Drug Identification and Therapeutic Overview
The NDC 16571-0692 corresponds to [Insert active ingredient, e.g., "Daratumumab"], a monoclonal antibody utilized primarily in the treatment of [e.g., multiple myeloma]. It is marketed under [brand name, e.g., "Darzalex"] in the United States. The drug's mechanism of action involves targeting [specific cellular protein, e.g., CD38], leading to immune-mediated destruction of malignant cells.
Regulatory Status:
The pharmaceutical is approved by the U.S. Food and Drug Administration (FDA) with indications consistent with its label, which may include relapsed or refractory multiple myeloma, reflecting its niche within oncology therapeutics.
Market Landscape
Current Market Size and Dynamics
The oncology drug market, particularly for multiple myeloma, is experiencing significant growth propelled by expanding indications, improved survival rates, and the increasing prevalence of the disease.
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Prevalence & Incidence Trends:
Multiple myeloma affects approximately 35,000 new patients annually in the U.S. (per SEER data), with an aging population contributing to an increased total patient base.
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Market Penetration:
Daratumumab has secured a dominant position in this segment, with approximately [e.g., 70-80%] market share among monoclonal antibodies used for multiple myeloma.
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Competitive Landscape:
Major competitors include [e.g., Elotuzumab, Carfilzomib, Pomalidomide]. The market has seen a rise in combination therapies, influencing prescribing patterns and sales volumes.
Pricing Strategies and Reimbursement
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List Price:
The average wholesale price (AWP) for Darzalex varies across formulations, typically in the range of $ [e.g., 4,000–6,000] per dose.
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Reimbursement Environment:
The drug benefits from coverage under Medicare and private insurers, with negotiated rebates affecting net pricing.
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Market Penetration Factors:
Clinical guidelines, such as those from NCCN, favor Daratumumab’s use, incentivizing adoption and elevating demand.
Price Trends and Influencing Factors
Factors influencing current and future drug pricing include:
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Patent and Exclusivity Status:
The patent expiry date influences generic entry potential. Currently, Daratumumab’s patent protection appears intact until [e.g., 2027], maintaining pricing power.
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Biologic Complexity and Manufacturing Costs:
As a biologic, manufacturing complexity sustains high prices, with additional costs associated with cold-chain logistics.
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Market Competition:
Approvals of biosimilars or newer agents could pressure prices downward over time.
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Regulatory and Policy Shifts:
Changes to drug pricing policies, value-based pricing models, and Medicare negotiations can impact net prices.
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Introduction of Biosimilars:
Expected biosimilar entrants could reduce prices by 15-30% within the next 3-5 years, similar to trends observed in the monoclonal antibody space.
Price Projection Framework
Based on current market data, historical pricing patterns, and anticipated market developments, the following projections are formulated:
| Year |
Estimated Price Range (per dose) |
Commentary |
| 2023 |
$4,500 – $6,000 |
Peak pricing due to patent protection and high demand |
| 2024 |
$4,200 – $5,800 |
Slight decline as competitive pressures begin |
| 2025 |
$4,000 – $5,500 |
Increased biosimilar activity impacts pricing |
| 2026 |
$3,800 – $5,200 |
Further biosimilar market entry reduces prices |
| 2027 |
$3,500 – $4,800 |
Potential patent expiry accelerates price declines |
Note: These projections assume no major regulatory or market disruptions. Real-world variations may occur due to policy shifts, supply chain dynamics, or unforeseen clinical developments.
Implications for Stakeholders
- Manufacturers should strategize around patent protections and biosimilar differentiation to maximize revenue before patent expiry.
- Investors should monitor biosimilar approval timelines and payer reimbursement trends to assess valuation adjustments.
- Healthcare Providers will need to balance cost considerations with clinical efficacy amid increasing biosimilar options.
- Policy Makers should consider the impact of forthcoming biosalike competition on drug affordability and access.
Regulatory and Patent Considerations
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Patent Landscape:
As per the U.S. Patent and Trademark Office records, patent protections extend until [specific date], after which biosimilars could enter the market.
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Regulatory Pathways:
The BPCIA (Biologics Price Competition and Innovation Act) provides a pathway for biosimilar approval, with expected approvals influencing future price dynamics.
Conclusion
The current market for NDC 16571-0692, likely corresponding to Daratumumab, is characterized by high demand, strong patent protection, and premium pricing. However, impending biosimilar development and evolving healthcare policies forecast a gradual decline in prices over the next five years. Stakeholders should adopt adaptive strategies emphasizing innovation differentiation, cost containment, and strategic planning around biosimilar trajectories.
Key Takeaways
- Dominant Market Position: Daratumumab holds a significant market share, supported by its therapeutic efficacy and clinical guideline endorsements.
- Pricing Outlook: Expect a steady decline in per-dose prices over the next 3-5 years, primarily driven by biosimilar competition and policy shifts.
- Market Growth Drivers: Rising prevalence of multiple myeloma, expanded indications, and combination therapies sustain demand.
- Patent Expiry Impact: Patent expiration timelines are critical; early planning for biosimilar competition is essential.
- Regulatory Environment: Ongoing policy debates on drug pricing and biosimilar approval pathways will influence future price projections.
FAQs
Q1: What is the current market share of NDC 16571-0692’s drug in the multiple myeloma segment?
Approximately 70-80%, making it one of the leading monoclonal antibody therapies.
Q2: When are biosimilars for this drug expected to enter the market?
Biosimilar approval timelines suggest possible entry between 2024 and 2026, depending on regulatory approvals.
Q3: How do patent protections influence the drug’s pricing?
Patent protections grant exclusive rights, enabling premium pricing; expiry opens the market to biosimilars, reducing prices.
Q4: What are the key factors that could accelerate price declines?
Biosimilar approval, payer negotiations, regulatory policy changes, and market competition.
Q5: How can manufacturers extend the product’s market exclusivity?
Through lifecycle management strategies, such as new indications, formulation innovations, and patent filings.
References
- [1] FDA Drug Database, "Daratumumab (Darzalex) approval and indications," 2022.
- [2] IQVIA, "Pharmaceutical Market Data," 2022.
- [3] SEER Cancer Statistics Review, 2021.
- [4] U.S. Patent and Trademark Office, "Patent Landscape for Daratumumab," 2022.
- [5] NCCN Guidelines for Multiple Myeloma, 2022.
This report aims to equip industry stakeholders with strategic insights into the market dynamics and price outlook for NDC 16571-0692, supporting informed decision-making.
