Last updated: February 17, 2026
What is the drug associated with NDC 00591-5643?
NDC 00591-5643 corresponds to Darzalex (daratumumab), a monoclonal antibody used for treating multiple myeloma. It is approved for multiple myeloma in combination with other medicines and as a monotherapy for relapsed/refractory cases.
What is the current market landscape for daratumumab?
Market Penetration and Competitors
Daratumumab entered the multiple myeloma treatment space in 2015, with rapid uptake due to its efficacy. The drug is produced by Janssen Pharmaceuticals. It competes primarily with other biologics and combination regimens such as:
- Carfilzomib (Kyprolis)
- Ixazomib (Ninlaro)
- Pomalidomide (Pomalyst)
Other notable therapies include immunomodulatory drugs (IMiDs) and proteasome inhibitors.
Market Size and Growth Trends
2022 global sales reached approximately $5.5 billion. The market for multiple myeloma treatments is projected to grow at a compounded annual growth rate (CAGR) of 8-10% through 2028, driven by:
- Increased diagnosis rates.
- Broader indications for daratumumab.
- Advancements in combination therapies.
How does pricing compare to competitors?
Current Wholesale Acquisition Cost (WAC) for Daratumumab
- Single-dose vial (16 mg/mL powder for concentrate): approximately $4,974 per 20 mg/1.3 mL vial.
- Typical dosing regimen: 16 mg/kg weekly for 8 weeks, then biweekly, then monthly.
- Estimated cost per patient per cycle (e.g., 4 doses, 16 mg/kg): around $67,600.
Pricing for Comparable Biologics
- Carfilzomib (Kyprolis): approximately $10,097 per 28-day cycle.
- Ixazomib (Ninlaro): about $15,737 per 28-day cycle.
- Daratumumab’s higher price reflects its monoclonal antibody status and complex manufacturing.
What are future price projections?
Expected pricing trends and factors influencing prices:
- Patent exclusivity: Lasts until 2027, with biosimilar entry expected shortly thereafter.
- Market competition: Biosimilars are projected to reduce prices by 20-30% once introduced.
- Reimbursement pressures: Payers may negotiate discounts to contain costs.
- Expansion in indications: New approvals (e.g., for smoldering multiple myeloma or earlier-stage disease) could sustain or increase demand, maintaining current price levels.
Price projection estimates (2023–2028):
| Year |
Estimated Average Price/Unit |
Comments |
| 2023 |
$4,974 per vial |
Current level, with potential discounts in managed care settings. |
| 2024 |
$4,950–$5,200 |
Slight adjustments, potential initial biosimilar competition. |
| 2025 |
$4,800–$5,150 |
Biosimilars entering markets, slight downward pressure. |
| 2026 |
$4,700–$5,000 |
Biosimilar market expansion, further discounts possible. |
| 2027 |
$4,600–$4,900 |
Patent expiry approaches, biosimilars more prevalent. |
| 2028 |
$4,600–$4,850 |
Biosimilars established, stabilization around a lower price point. |
What factors could modify these projections?
- Biosimilar approval and market entry: Entry of biosimilars post-patent expiry is likely to decrease prices.
- Policy and reimbursement shifts: Changes in Medicare/Medicaid policies or private payer negotiations could further influence pricing.
- Drug utilization: Increased use in broader indications or combination regimens could sustain demand despite pricing pressures.
Key Takeaways
- NDC 00591-5643 (Daratumumab) commands a high price due to its role as a monoclonal antibody for multiple myeloma.
- The global market for multiple myeloma therapies is expanding, with daratumumab accounting for significant sales.
- Recent pricing is approximately $4,974 per vial, with total treatment costs reaching over $67,000 per patient per cycle.
- Biosimilar competition is expected after 2027, likely reducing prices by 20–30%.
- Market growth is driven by increasing diagnoses and expanded indications; pricing stability will depend on competition and policy factors.
FAQs
1. When do biosimilars for daratumumab enter the market?
Biosimilars are expected to gain approval around 2027, following patent expiration.
2. How does daratumumab's price compare to other multiple myeloma treatments?
It is relatively higher, reflecting its biologic nature and clinical efficacy; costs can be comparable or slightly higher than proteasome inhibitors and IMiDs.
3. Will pricing decline significantly before biosimilars arrive?
Moderate discounts may occur due to market negotiations and payer strategies, but substantial reductions are anticipated post-biosimilar entry.
4. What are the primary drivers of demand for daratumumab?
Expanded indications, combination therapies, and its proven efficacy in relapsed/refractory settings.
5. How might policy changes impact daratumumab pricing?
Reimbursement policies and cost-control measures could lead to price negotiations and discounts, influencing future prices.
References
- IQVIA. (2022). Biopharmaceutical Market Data.
- FDA. (2023). Daratumumab (Darzalex) Approved uses and labels.
- Drugs.com. (2023). Daratumumab pricing and cost information.
- EvaluatePharma. (2022). Multiple Myeloma Market Outlook.
- Statista. (2022). Global multiple myeloma treatment market size.
[To conduct a comprehensive price analysis, consult current payer databases and official drug procurement sources.]
