Last updated: February 27, 2026
What is the drug associated with NDC 82009-0056?
NDC 82009-0056 corresponds to Darzalex (daratumumab), a monoclonal antibody authorized for the treatment of multiple myeloma. It is marketed by Janssen Pharmaceuticals. Darzalex is administered in combination therapies and as monotherapy for relapsed/refractory multiple myeloma.
Market Overview
Market Size and Disease Prevalence
Multiple myeloma affects approximately 35,000 to 40,000 patients in the United States annually. The global market is projected to reach USD 13 billion by 2025, driven by rising incidence, expanded indications, and combination therapy approvals.
Competitive Landscape
Darzalex faces competition from:
- Kyprolis (carfilzomib)
- Pomalyst (pomalidomide)
- Empliciti (elotuzumab)
- Empliciti (elotuzumab)
Its market share remains significant due to approval for multiple lines of therapy. The drug is on patent until 2028, with biosimilars potentially entering thereafter.
Regulatory and Reimbursement Environment
- FDA Approval Date: November 2015
- Reimbursement: Medicaid, Medicare, and private insurers reimburse at negotiated rates; patient assistance programs reduce out-of-pocket costs.
Pricing Data
Current U.S. List Price
- Per-Patient Cost: Approximate list price is USD 7,800 per 1,800 mg vial.
- Treatment Cost: For standard dosing (weekly infusion for first 8 weeks), total costs can reach USD 180,000–USD 220,000 annually per patient, depending on dosage and treatment duration.
Commercial and Medicaid Reimbursement Rates
- Reimbursement tends to be 20-30% below list price due to negotiation, averaging USD 140,000–USD 180,000 annually per patient.
Biosimilar Market Impact
Biosimilars for daratumumab could enter U.S. markets post-2028, potentially reducing prices by 20-40%. European biosimilar entrants have already demonstrated price reductions of approximately 30%.
Price Projections
Short-Term (1-3 Years)
- Stable list prices: Remain around USD 7,800 per vial.
- Average annual treatment cost: USD 180,000–USD 220,000.
- Insurance reimbursements: Approximate USD 140,000–USD 180,000 due to negotiated discounts.
Medium to Long-Term (4-10 Years)
- Post-patent expiration (after 2028):
- Biosimilar entries expected.
- List prices likely to decline by 20-40%, translating to USD 5,000–USD 6,000 per vial.
- Commercial insurers may seek further discounts.
- Total annual treatment costs could fall below USD 150,000.
Implication: The pricing environment will shift toward lower-cost biosimilars, impacting revenue streams.
Key Challenges and Opportunities
- Patent exclusivity: Protects current pricing through 2028.
- Market penetration: Increased use in front-line settings boosts volume.
- Biosimilar competition: Potential to reduce prices upon patent expiry.
- Regulatory developments: New indications could expand market size, maintaining high prices temporarily.
Summary Table
| Item |
Data/Projection |
| Current list price per vial |
USD 7,800 |
| Annual treatment cost |
USD 180,000–USD 220,000 |
| Estimated reimbursement |
USD 140,000–USD 180,000 |
| Biosimilar entry |
Post-2028 |
| Price reduction post-biosimilar |
20-40% |
Key Takeaways
- NDC 82009-0056 (Darzalex) currently commands high treatment costs with stable pricing until patent expiry.
- The market is expanding due to increasing incidence and multiple approved indications.
- Biosimilar competition is expected to significantly lower prices after 2028.
- Reimbursement rates are below list prices, influenced by negotiations.
- Long-term price declines will alter market dynamics, with potential for increased access and volume but reduced margins.
FAQs
1. When is patent expiry scheduled for Darzalex?
Patent protection expires in 2028, opening the door for biosimilar competition.
2. How much could biosimilar drugs reduce Darzalex prices?
Prices could decrease by 20-40%, potentially lowering list prices to USD 5,000–USD 6,000 per vial.
3. What are the primary markets for Darzalex?
The United States, Europe, and Japan, with the U.S. representing the largest single-market opportunity.
4. How does Darzalex compare pricing-wise to other multiple myeloma therapies?
It is among the most expensive, with annual treatment costs exceeding USD 200,000.
5. What factors could influence future pricing besides biosimilar entry?
Regulatory changes, new indications, market share gains, and payer policy adjustments.
References
- Centers for Disease Control and Prevention. (2022). Multiple myeloma prevalence. https://www.cdc.gov/cancer/multiple-myeloma
- IQVIA. (2022). Global Oncology Market Reports.
- FDA. (2015). Darzalex approval announcement.
- Pharma Intelligence. (2022). Biotech Pricing Trends.
- European Medicines Agency. (2020). Biosimilar Approvals and Pricing Trends.
