Last updated: February 20, 2026
What is NDC 64896-0664?
NDC 64896-0664 corresponds to a specific pharmaceutical product approved by the FDA. The NDC code is a unique identifier used in the United States for drugs, indicating the manufacturer, product, and package size. The product associated with this NDC is Darzalex (daratumumab), a monoclonal antibody used primarily in the treatment of multiple myeloma.
Market Overview
Indications and Clinical Position
Darzalex is indicated for:
- Newly diagnosed multiple myeloma in combination with other agents
- Relapsed or refractory multiple myeloma as monotherapy or combined with other treatments
Its approval history includes:
- Original approval in November 2015
- Expanded indications in the subsequent years, including in combination therapies
Market Size and Dynamics
The multiple myeloma drug market is global, valued at approximately USD 9.8 billion in 2022, with a compound annual growth rate (CAGR) of 12% projected through 2028 [1].
Within this, monoclonal antibodies represent a dominant segment, driven by the approval of drugs like Darzalex, which holds a significant market share. Darzalex's sales were USD 4.27 billion globally in 2022, representing a 22% increase from 2021 [2].
Competitive Landscape
Primary competitors include:
- Carfilzomib (Kyprolis)
- Bortezomib (Velcade)
- Isatuximab (Sarclisa)
- Idecabtagene vicleucel (Abecma)
Market share concentration:
| Drug |
2022 Global Sales (USD billion) |
Market Share (%) |
| Darzalex |
4.27 |
43.6 |
| Carfilzomib (Kyprolis) |
0.92 |
9.4 |
| Bortezomib (Velcade) |
1.35 |
13.8 |
| Others |
2.76 |
28.2 |
Price Trends and Reimbursement
The wholesale acquisition cost (WAC) for Darzalex:
- 2022 average price per 1400 mg vial: USD 7,200
- Monthly treatment cost for typical regimens: USD 20,000–30,000 depending on dosage and combinations
Reimbursement varies by payer, with Medicare and commercial insurers covering most of the treatment costs.
Price Projections
Short-Term (Next 1-2 Years)
- Price Stability: WAC is expected to remain stable, barring major policy shifts.
- Price Increase Factors:
- Inflation-driven pharmacy cost increases (~3-5% annually)
- Potential for increased price due to expanded indications or new formulations
Medium to Long Term (3-5 Years)
- Market Competition: Entry of biosimilars is unlikely due to patent protections and exclusivities until at least 2027, delaying price erosion.
- Price Trends:
- Prices may decline modestly (~10-15%) due to discounting and payer negotiations if biosimilars or similar agents enter the market.
- Overall, the treatment cost is forecasted to grow at an inflation rate of 3-4% annually.
Impact of Biosimilar Entry
Patent expirations and biosimilar developments for daratumumab could:
- Reduce prices by 20-40% upon launch
- Increase market competition and drive innovation
Current biosimilar candidates are in late-stage development; FDA approval is expected post-2024 [3].
Revenue and Market Share Projections
Based on current sales and market dynamics:
| Year |
Projected Global Sales (USD billion) |
Key Factors |
| 2023 |
4.6 |
Stable sales, emerging biosimilar competition |
| 2024 |
4.3 |
Slight decline due to biosimilar pressure |
| 2025 |
4.1 |
Continued biosimilar market penetration |
| 2026 |
3.8 |
Possible pricing adjustments, patent expiry |
| 2027 |
3.6 |
Biosimilar entry, price reductions likely |
Regulatory and Policy Influences
- Patent protections extend until 2026–2027.
- Pricing pressures due to healthcare policy reforms targeting drug costs.
- Access programs and formulary restrictions may influence net prices.
Key Takeaways
- Darzalex remains a leading therapy in multiple myeloma with robust sales growth.
- Prices are projected to remain stable in the near term, with slight declines possible as biosimilars enter the market.
- Growth potential depends on expanding indications and ability to maintain market share amidst increased competition.
- Entry of biosimilars around 2025–2027 could significantly impact pricing strategies and revenue.
FAQs
Q1: When will biosimilars for daratumumab become available?
A1: Biosimilars are in late-stage development, with FDA approval expected after 2024, impacting market pricing from 2025 onward.
Q2: How does daratumumab compare in price to other multiple myeloma treatments?
A2: Its monthly treatment costs range from USD 20,000 to USD 30,000, placing it among the higher-cost options in its class.
Q3: What factors could accelerate or slow down price declines?
A3: Patent protections, regulatory delays, market acceptance, and payer negotiations influence pricing trends. Biosimilar approvals and market entry are primary catalysts for price reductions.
Q4: How has the COVID-19 pandemic affected daratumumab sales?
A4: Pandemic-related disruptions temporarily slowed treatment initiation, but sales rebounded as healthcare systems adapted, maintaining positive growth trajectories.
Q5: What are the key opportunities for profitability growth?
A5: Expanding indications, optimizing combination therapies, and early biosimilar negotiations can sustain revenue streams.
References
[1] IQVIA. (2023). Global Oncology Market Report. IQVIA.
[2] Evaluate Pharma. (2023). 2022 Oncology Sales Data. Evaluate Pharma.
[3] U.S. Food and Drug Administration. (2023). Biosimilar Development and Approval. FDA.
