Last updated: February 25, 2026
What is the Drug NDC 69315-0331?
NDC 69315-0331 is a specific National Drug Code assigned to a particular formulation of a pharmaceutical product. Based on available data, this NDC corresponds to Daratumumab (Darzalex), a monoclonal antibody used in the treatment of multiple myeloma.
Market Overview
Current Market Dynamics
- Indication: Multiple myeloma, a plasma cell cancer affecting approximately 32,000 new cases annually in the US.
- Market Penetration: Daratumumab was approved by the FDA in 2015 and has become a standard component in multiple myeloma regimens.
- Competitive Landscape: Includes other monoclonal antibodies like Elotuzumab (Empliciti) and isatuximab (Sarclisa). The key competitors are primarily biologics with high development and manufacturing costs.
Market Size and Growth
| Parameter |
Value |
| US Multiple Myeloma Patients |
32,000 (annual new cases) |
| Estimated Market Penetration (2023) |
60% of eligible patients |
| Total Addressable Market (TAM) |
$2.5 billion (2023, estimated) |
| CAGR (2023-2028) |
8-10% |
Based on CDC and industry reports, the U.S. multiple myeloma market is expected to grow at 8-10% annually, driven by increased diagnosis, improved survival rates, and expanded indications.
Regulatory and Reimbursement Trends
- FDA approved for multiple lines of therapy, including combination therapy.
- Reimbursement from CMS and private insurers generally favorable, though drug pricing remains scrutinized.
Price Analysis
Historical Pricing Data
- Average Wholesale Price (AWP): Approximately $6,000 per vial, with typical dosage of 20 mg/kg (up to 1.3 g per administration).
- Per Course Cost: Approximately $47,000 - $50,000, assuming standard dosing schedules.
Pricing Trends
| Year |
Approximate AWP per vial |
Average Total Treatment Cost |
Notes |
| 2015 |
$4,500 - $5,500 |
$40,000 - $45,000 |
Initial Launch |
| 2020 |
$6,200 - $6,500 |
$50,000 - $55,000 |
Price increases observed |
| 2023 |
$6,000 - $6,800 |
$47,000 - $55,000 |
Stable with slight upward trend |
Pricing adjustments reflect manufacturing costs, inflation, and market competition.
Future Price Projections
Assuming standard inflation and market dynamics:
- 5-year outlook (2024-2028): Prices could increase 2-4% annually.
- Projected AWP per vial in 2028: $6,650 - $7,100.
- Projected treatment cost range: $52,000 - $60,000 per course.
Price rises depend on regulatory changes, payer negotiations, and manufacturing cost shifts.
Factors Influencing Future Pricing
- Entry of biosimilars: No current biosimilar competition for Daratumumab; potential entry projected post-2030.
- Manufacturing efficiency: Improvements may mitigate price increases.
- Reimbursement policies: Cost-control measures could restrain pricing.
- Indication expansions: New approved uses may increase overall revenue without affecting per-unit price.
Key Takeaways
- NDC 69315-0331 (Daratumumab) holds a dominant position within multiple myeloma treatment, with significant market growth potential.
- The U.S. market is projected to grow at 8-10% annually, supported by increasing diagnosis and treatment adoption.
- Current price per vial hovers around $6,000, with treatment costs averaging $50,000.
- Price projections suggest modest annual increases of 2-4%, influenced by regulatory, competitive, and cost factors.
- Biosimilar competition, once approved, could dramatically alter the pricing landscape post-2030.
FAQs
1. How likely are biosimilars to impact Daratumumab pricing?
Biosimilar versions are anticipated after patent expiry around 2030. Their entry could lead to significant price reductions, similar to other biologics.
2. Are there alternative therapies that could replace Daratumumab?
Yes, newer agents and combination therapies regularly emerge, but Daratumumab remains core in multiple myeloma treatment due to efficacy.
3. What are the major cost drivers for Daratumumab?
Manufacturing complexity, research and development expenses, and regulatory compliance contribute heavily to costs.
4. How do reimbursement policies affect drug pricing?
Reimbursement negotiations and formulary placements influence net revenue and potentially restrict list-price increases.
5. How does market competition influence future price projections?
Limited direct competition currently allows for stable pricing, but increased competition from biosimilars could push prices downward.
References
[1] U.S. Food and Drug Administration. (2015). FDA approves Darzalex for multiple myeloma.
[2] IQVIA. (2023). US Oncology Trend Report.
[3] CDC. (2022). Multiple Myeloma—Statistics.
[4] Market Data Forecast. (2023). Biologics Market Forecast.
[5] Center for Medicare & Medicaid Services. (2023). Reimbursement policies for oncology medications.
