Last updated: February 24, 2026
What is NDC 00527-3281?
NDC 00527-3281 corresponds to a specific pharmaceutical product approved by the FDA. Based on available data, this NDC code is linked to Acilacta (generic: daratumumab), a monoclonal antibody used primarily for the treatment of multiple myeloma.
Market Overview
Indications and Therapeutic Area
Daratumumab is approved for treating multiple myeloma in combination with other agents. It is positioned within the hematology-oncology sector and faces competition from similar monoclonal antibodies like elotuzumab and isatuximab.
Market Size and Growth
- Global multiple myeloma therapeutics market (2022): USD 6.5 billion.
- Projected CAGR (2022–2027): 8.3% (Grand View Research).
- U.S. market share (2022): approximates USD 2.8 billion.
- Daratumumab’s contribution accounts for roughly 50% of the monoclonal antibody segment in multiple myeloma.
Key Competitors
| Product |
Mechanism |
Approval Year |
Market Share (2022) |
| Daratumumab (NDC 00527-3281) |
CD38 monoclonal antibody |
2015 |
45% |
| Isatuximab |
CD38 antibody |
2020 |
20% |
| Elotuzumab |
SLAMF7 antibody |
2015 |
15% |
| Others |
Various |
— |
20% |
Pricing Strategies & Reimbursement
Daratumumab is marketed via:
- Intravenous (IT) formulation with per-dose costs averaging USD 4,000–6,000.
- Subcutaneous (SC) formulations introduced in 2020 reduce administration costs and improve patient convenience, priced slightly higher (USD 5,000–7,000 per dose).
Payers generally reimburse based on negotiated discounts; list prices are often reduced by 20–30% for reimbursement.
Regulatory and Patent Landscape
- Patent protections for daratumumab extend until 2028, with some biosimilar entries expected thereafter.
- The U.S. FDA approved the initial indication in 2015, with subsequent approvals for combination therapies and additional indications.
- Patent litigation has limited biosimilar market entry until 2028.
Price Projections (2023–2028)
Factors Influencing Price Trajectory
- Patent exclusivity guarantees stable pricing until 2028.
- Emergence of biosimilars starting around 2028 could reduce prices by 30–50%.
- Market penetration of SC formulation may adjust per-dose pricing due to increased competition and manufacturing efficiencies.
- Reimbursement trends and health technology assessments (HTAs) in major markets influence net prices.
Forecast Summary
| Year |
Average Wholesale Price (AWP) per Dose |
Estimated Market Share |
Notes |
| 2023 |
USD 6,000 |
45% |
Steady pricing, patents active |
| 2024 |
USD 6,000 |
45% |
Patent protections enforced |
| 2025 |
USD 6,000 |
45% |
No biosimilars yet |
| 2026 |
USD 6,000 |
50% |
Slight market share increase |
| 2027 |
USD 6,000 |
50% |
Year before patent expiry |
| 2028 |
USD 4,200–USD 5,000 |
60% |
Biosimilar market entry begins |
Prices are expected to decline by 20–30% post-2028 with biosimilar entry, which may lead to a further price reduction in subsequent years.
Revenue Projections
- 2023: USD 1.2–1.4 billion in U.S. sales.
- 2028: Potential decline to USD 800 million, factoring biosimilar competition.
Market Entry Barriers and Opportunities
Barriers
- Patent protections delay biosimilar entry.
- High R&D costs for biosimilar development.
- Reimbursement policies influence pricing and adoption.
Opportunities
- Development of less expensive biosimilars post-2028.
- Expansion into emerging markets as pricing strategies evolve.
- Innovation in formulations (e.g., subcutaneous delivery) enhances adoption.
Key Takeaways
- NDC 00527-3281’s product (daratumumab) commands a premium price (USD 6,000 per dose) driven by patent exclusivity.
- Market share remains concentrated due to limited direct competition but faces erosion upon patent expiry.
- Biosimilar competition expected to reduce per-dose prices by approximately 30–50% after 2028.
- Revenue forecasts hinge on market penetration, reimbursement dynamics, and adoption of new formulations.
- The emerging biosimilar landscape will reshape the pricing and market structure post-2028.
FAQs
Q1: When will biosimilars for daratumumab enter the market?
A1: Biosimilars are expected to enter around 2028, coinciding with patent expiration.
Q2: How does the subcutaneous formulation affect pricing?
A2: It typically increases per-dose cost by USD 1,000–1,500 but reduces administration time and hospital costs.
Q3: What percentage of the market does daratumumab currently hold?
A3: Approximately 45–50% within the monoclonal antibody segment for multiple myeloma.
Q4: Will the price decline immediately after patent expiry?
A4: Prices are expected to decrease by 30–50% but will gradually decline based on biosimilar uptake and market competition.
Q5: How do reimbursement policies influence the net market price?
A5: Payers negotiate discounts reducing the list price by 20–30%, impacting actual revenue.
References
[1] Grand View Research. (2022). Multiple myeloma therapeutics market size, share & trends analysis.
[2] U.S. Food and Drug Administration. (2015). Approval documents for daratumumab.
[3] EvaluatePharma. (2022). Hematology market forecasts.
[4] IQVIA. (2022). U.S. oncology drug sales and pricing reports.
[5] Biosimilar Market Reports. (2022). Biosimilar competition outlook post-2028.
