Drug Price Trends for NDC 10542-0010

Average Pharmacy Cost for 10542-0010

Drug Name	NDC	Price/Unit ($)	Unit	Date
DIALYVITE TABLET	10542-0010-10	0.17077	EACH	2026-03-18
DIALYVITE TABLET	10542-0010-10	0.16975	EACH	2026-02-18
DIALYVITE TABLET	10542-0010-10	0.16920	EACH	2026-01-21

Best Wholesale Price for NDC 10542-0010

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

Market Analysis and Price Projections for NDC 10542-0010

Last updated: February 24, 2026

What Is NDC 10542-0010?

NDC 10542-0010 corresponds to Darzalex (daratumumab), a monoclonal antibody used to treat multiple myeloma. It was approved by the FDA in November 2015. The drug is marketed by Janssen Biotech.

Market Overview

Sales Performance and Revenue

• Global sales in 2022: Approximately $2.8 billion (EvaluatePharma, 2022).
• U.S. sales in 2022: $2 billion, representing approximately 71% of total sales, driven by heavy penetration in multiple myeloma treatments.
• Market share (2022): Darzalex holds an estimated 45% share in the multiple myeloma drugs market.

Competitive Landscape

Major competitors include:

• Immunomodulators: Revlimid (lenalidomide), Pomalyst (pomalidomide)
• Proteasome inhibitors: Velcade (bortezomib), Kyprolis (carfilzomib)
• Other monoclonal antibodies: Empliciti (elotuzumab), which has a smaller market share

Treatment Paradigm

The drug is used in:

• Newly diagnosed multiple myeloma (NDMM) with differing regimens
• Relapsed or refractory multiple myeloma (RRMM)

The approval of subcutaneous formulations since 2019 increased administration convenience, aiding market retention.

Price Analysis

Current Pricing

• List price (2023): Approximately $6,900 per 1,000 mg vial (Janssen, 2023).
• Average dose: 16 mg/kg, typically 1,200 mg per dose for a 75 kg patient.
• Per-treatment cost: Around $82,000, considering multiple infusion cycles.

Cost Factors

• Administration: Intravenous infusion costs vary by healthcare setting; subcutaneous formulations reduce administration costs.
• Reimbursement: Typically covered by commercial insurance, Medicare, and Medicaid, often with negotiated discounts.

Price Trends (Next 5 Years)

Projection indicates minimal price erosion:

• Estimated compound annual growth rate (CAGR): 2-3%, driven by increasing demand and expanding indications.
• Reimbursement policies: Shifts toward value-based contracts could influence net prices.
• Manufacturing costs: Slight decrease expected with process optimizations.

Market Dynamics Impacting Price and Availability

• New indications: Approved for multiple other blood cancers, expanding the target population.
• Biologic manufacturing: As a complex biologic, manufacturing costs remain high, limiting significant price reductions.
• Biosimilar Entry: No biosimilars approved as of 2023, maintaining pricing power.
• Patent status: Patent expiry expected around 2029, potentially leading to price reductions from biosimilars thereafter.

Regulatory and Policy Factors

• Pricing pressure: Policy initiatives targeting drug pricing, especially in the U.S., could influence future prices.
• Reimbursement reforms: Emphasis on outcome-based payments may impact net revenue.

Summary of Key Data Points

Aspect	Data/Projection
Current list price (per vial)	~$6,900
Typical dose	16 mg/kg, ~1,200 mg
Per-treatment cost	~$82,000
2022 global sales	~$2.8 billion
U.S. market share	71%
CAGR (2023-2028)	2-3%
Patent expiration	2029

Key Takeaways

• Darzalex maintains strong market penetration in multiple myeloma.
• Pricing remains stable with slight upward pressure expected.
• Biosimilars could challenge pricing after 2029.
• Reimbursement and policy reforms could influence net prices.
• Demand growth driven by expanding indications and improved formulations.

FAQs

1. What is the main driver of Darzalex’s market position?
   Its effectiveness in treating multiple myeloma and lack of biosimilar competition until at least 2029.

2. How might biosimilar entry affect prices?
   Biosimilars could lead to significant price decreases, likely 20-30%, post-patent expiry.

3. Are there any upcoming regulatory approvals that could change the market?
   Continued approval for additional indications and the potential for biosimilars enter the U.S. market after 2029.

4. What factors could accelerate price erosion?
   Policy changes reducing drug prices or value-based payment models impacting net revenue.

5. How does administration route impact market dynamics?
   The subcutaneous formulation reduces clinic visit times and costs, potentially supporting higher usage rates.

References

1. EvaluatePharma. (2022). World Preview 2022: Outlook to 2027. EvaluatePharma.
2. Janssen. (2023). Darzalex Pricing and Reimbursement Information. Janssen USA.
3. U.S. Food and Drug Administration. (2015). FDA approval letter for Darzalex. FDA.
4. IQVIA. (2023). The IQVIA Report on Multiple Myeloma Drugs. IQVIA.