Last updated: February 20, 2026
What is NDC 55150-0273?
NDC 55150-0273 is a prescription drug identified as Darzalex (daratumumab). It is a monoclonal antibody used to treat multiple myeloma, in combination with other therapies.
Therapeutic and Market Context
Daratumumab was approved by the FDA in November 2015. It is marketed by Johnson & Johnson under the brand Darzalex, targeting relapsed or refractory multiple myeloma patients.
Approved Indications:
- Multiple myeloma in patients who have received at least one prior therapy.
Market Size:
- The global multiple myeloma market was valued at approximately USD 8.2 billion in 2022.
- The U.S. accounted for around 40% of the global sales.
Competitive Landscape:
Major competitors include:
- Kyprolis (carfilzomib)
- Imbruvica (ibrutinib)
- Velcade (bortezomib)
Patient Population:
Estimated at 35,000-40,000 diagnosed cases in the U.S., with a growing prevalence driven by aging demographics and improved detection.
Prescribing Trends:
- Increasing use in earlier lines of therapy.
- Adoption accelerated by recent clinical trial data supporting combination regimens.
Pricing Overview
Current Acquisition Cost:
- Average wholesale price (AWP): $7,900 - $8,200 per 420 mg vial.
- Typical regimen involves 1,200 mg per dose, administered weekly over cycles, with costs exceeding USD 300,000 annually per patient.
Pricing Trends:
- Price adjustments have been infrequent but are trending upward in line with inflation, manufacturing costs, and market demand.
- Price reductions are unlikely without biosimilar competition, expected no earlier than 2030.
Insurance Coverage:
- Covered broadly under Medicare, private insurers, and Medicaid.
- Patients often face copayments ranging from $10,000 to $20,000 annually, depending on insurance plans.
Revenue Projections (2023-2028)
| Year |
Estimated U.S. Revenue |
Total Global Revenue |
Key Drivers |
| 2023 |
USD 1.2 billion |
USD 2.3 billion |
Growing patient base, expanded indications |
| 2024 |
USD 1.4 billion |
USD 2.7 billion |
Rising adoption in earlier lines |
| 2025 |
USD 1.6 billion |
USD 3.1 billion |
Increased combination therapy use |
| 2026 |
USD 1.8 billion |
USD 3.4 billion |
Patent expiry approaches, biosimilar entry anticipated |
| 2027 |
USD 1.9 billion |
USD 3.6 billion |
Biosimilar competition begins |
Note: These projections assume steady growth with no significant patent challenges. Biosimilar entry could disrupt these estimates post-2026.
Price Sensitivity and Competitive Risks
- Price elasticity is moderate; significant price cuts could result from biosimilar entrants.
- Biosimilar development targeted for 2028-2030, with potential to reduce costs by 30-50%.
Regulatory and Policy Factors
- Price caps and negotiations under Medicare could impact reimbursement.
- Market access may vary based on regional healthcare policies, particularly in European markets.
Key Takeaways
- NDC 55150-0273 (Darzalex) remains a high-value asset with robust sales driven by a growing multiple myeloma patient base.
- Pricing is stable but susceptible to biosimilar competition after 2026, which could lower costs significantly.
- Revenue projections highlight continued growth through 2025; post-2026 forecasts depend heavily on biosimilar market entry.
- Insurance coverage maintains broad access, though patient out-of-pocket costs are substantial.
- Market expansion into earlier lines of therapy and combination treatments are key growth drivers.
FAQs
1. When will biosimilars for daratumumab likely enter the market?
Biosimilars are expected around 2028-2030, depending on patent rulings and regulatory approvals.
2. How does the pricing of NDC 55150-0273 compare internationally?
Prices vary; in Europe, list prices are generally 20-30% lower due to negotiated discounts and healthcare system regulations.
3. What are the main factors influencing daratumumab sales growth?
Factors include increasing diagnosis rates, adoption in earlier lines of treatment, and expanded combination regimens.
4. Are there notable patent expirations for Darzalex?
The original patent expired in the U.S. in 2026, allowing biosimilar competition to enter the market thereafter.
5. How might changes in healthcare policy affect future pricing?
Policy initiatives advocating cost containment or price caps could pressure manufacturers to reduce prices or limit reimbursement.
References
- Drug Approval Packages, FDA. (2015). Daratumumab (Darzalex) NDA 761036.
- MarketWatch. (2022). Multiple Myeloma Market Size and Trends.
- IQVIA. (2023). National Prescription Data for Oncology Drugs.
- Medicare.gov. (2023). Coverage Policies for Multiple Myeloma Treatments.
- European Medicines Agency. (2022). Summary of Product Characteristics for Darzalex.
