Last updated: February 17, 2026
What is NDC 72511-0750?
NDC 72511-0750 corresponds to a monoclonal antibody product used for the treatment of multiple myeloma, approved by the FDA in 2020. Its active ingredient is daratumumab, marketed under the brand name Darzalex.
Market Size and Growth
Current Market Scope:
- The global multiple myeloma treatment market was valued at approximately $5.8 billion in 2022.
- Daratumumab holds a dominant position, accounting for roughly 50% of the monoclonal antibody segment in hematologic malignancies.
- Its approved indications expanded to include newly diagnosed and relapsed/refractory multiple myeloma.
Market Drivers:
- Rising incidence of multiple myeloma: approximately 35,000 new cases annually in the U.S.
- Increasing adoption of targeted therapies over conventional chemotherapies.
- Expansion into combination regimens with other agents such as pomalidomide and bortezomib.
Competitive Landscape:
- Main competitors include carfilzomib, pomalidomide, and other novel agents.
- Biosimilar development remains limited but is expected to increase, especially outside the U.S.
Pricing Analysis
Current Price Point (U.S.):
- List price per 1,800 mg vial approximates $4,200.
- Typical regimen: 16 mg/kg administered weekly for 8 weeks, then biweekly.
Cost Breakdown:
| Parameter |
Data |
| Average dose |
16 mg/kg for a 70 kg patient (~1,120 mg) |
| Dose per infusion |
1,120 mg (per cycle), using vials of 1,800 mg |
| Number of vials per infusion |
1 vial (~1,800 mg), with surplus or split dosing |
| Cost per infusion |
~$4,200 |
| Total treatment duration |
Up to 12 months, with approximately 24 doses |
Pricing Trends:
- List prices have remained stable since 2020 but are under pressure from insurers and biosimilar entrants.
- Rebates and discounts significantly affect net prices, which are estimated to be 40-60% below list.
Price Projections (2023-2030)
Factors Influencing Price Trends:
- Biosimilar entry predicted to occur within 3-5 years, particularly in Europe and Asia.
- Payer negotiations and formulary placements will continue to exert downward pricing pressure.
- Regulatory pathways favor biosimilar approvals, which may lead to 15-30% reduced price points over the next five years.
Projections Summary:
| Year |
Estimated Average Price (U.S.) |
Notes |
| 2023 |
$4,200 |
Current list price, subject to discounts |
| 2025 |
$3,600 |
Anticipated biosimilar competition, discount pressure |
| 2027 |
$3,300 |
Biosimilar market penetration expected to intensify |
| 2030 |
$2,700 |
Potential for further price reductions, regulatory and market dynamics |
Regulatory and Market Impact
- FDA fast-track and orphan drug designations have extended patent protections and market exclusivity.
- The exit of originator from some markets could accelerate biosimilar adoption.
- Reimbursement models favor lower-cost options, pushing prices downward.
Key Takeaways:
- NDC 72511-0750 (daratumumab) is a leading therapy for multiple myeloma, with an established price of approximately $4,200 per vial.
- The market is expanding due to increased incidence and combination therapy use; however, pricing faces downward pressure from biosimilars, regulatory changes, and payer negotiating power.
- Price reductions of 15-30% are projected over the next five years with biosimilar entry and increased competition.
- Market dynamics suggest a plateau in list prices but significant discounts at the payer level.
FAQs
Q1: When are biosimilars for daratumumab expected to enter the U.S. market?
A1: Biosimilars are projected to launch within 3-5 years, with regulatory filings already under review or in development.
Q2: How does the cost-effectiveness of daratumumab compare with newer therapies?
A2: Daratumumab has demonstrated significant survival benefits in multiple myeloma, but cost-effectiveness varies based on dosage, treatment duration, and comparison to emerging therapies.
Q3: What are the main barriers to price reductions?
A3: Patent protections, regulatory exclusivity, and limited biosimilar competition in the U.S. restrict rapid price declines.
Q4: How do reimbursement policies impact pricing?
A4: Payer negotiations and value-based reimbursement models influence net prices, often leading to discounts and formulary exclusions.
Q5: In which regions are biosimilar prices expected to be lower?
A5: Europe and Asia are expected to see quicker adoption and lower prices due to regulatory pathways and market competition.
Citations:
- Global Market Insights. "Multiple Myeloma Treatment Market," 2022.
- FDA. "Daratumumab (Darzalex) Approval Status," 2020.
- IQVIA. "Pharmaceutical Pricing and Reimbursement Report," 2022.
- EvaluatePharma. "Biosimilar Outlook," 2022.
- Medicare & Medicaid Services. "Pricing and Reimbursement Policies," 2023.
