Last updated: March 1, 2026
What is NDC 00591-3220?
NDC 00591-3220 refers to a pharmaceutical product identified by the National Drug Code. Based on available databases, this NDC corresponds to Darzalex (daratumumab), a monoclonal antibody used in the treatment of multiple myeloma.
Market Overview
Indications and Usage
- Primary indication: Multiple myeloma, both in newly diagnosed and relapsed/refractory settings.
- Mechanism: Targets CD38, inducing immune-mediated tumor cell death.
- Approval Dates: Approved by FDA in November 2015 for multiple myeloma [1].
Market Size
- The global multiple myeloma market was valued at approximately $8 billion in 2022.
- Darzalex accounts for an estimated 40% market share within this segment.
- Revenue from Darzalex was approximately $4 billion in 2022, globally.
Competitive Landscape
- Main competitors include Empliciti (elotuzumab), Pomalyst (pomalidomide), and Revilim (elotuzumab).
- Market share distribution remains concentrated among a few key players, with increasing penetration of biosimilars in certain territories.
Pipeline and Expansion
- Regulatory filings for Darzalex are active in multiple indications including smoldering myeloma and solid tumors.
- Combination therapies with proteasome inhibitors, immunomodulatory agents, and CAR-T therapies are in advanced clinical trials, potentially expanding market size.
Price Trends and Projections
Current Pricing
- Usual Wholesale Acquisition Cost (WAC): Approximately $6,800 per 100 mg vial.
- Average treatment course: 1,800-2,400 mg, resulting in total costs of $122,400 to $163,200 per patient annually.
- Reimbursement patterns: Commercial insurers and Medicare Part B coverage influence net prices.
Market Dynamics Influencing Pricing
- Biosimilar Entry: Biologic patent exclusivity typically lasts 12 years; patent for Darzalex expires in 2027 in the US [2]. Biosimilar entry post-2027 likely to reduce prices by 20-40%.
- Reimbursement Policies: Shift towards value-based arrangements could pressure gross to net discounts.
- Manufacturing and Supply Costs: Stable, with minimal expected impact on price unless supply chain disruptions occur.
Price Projections (2023-2030)
| Year |
Estimated WAC Price per 100 mg Vial |
Expected Trends |
Comment |
| 2023 |
$6,800 |
Price stabilization, increased volume sales |
Minority biosimilar competition, still premium priced |
| 2024 |
$6,700 |
Marginal decline, price negotiations intensify |
Anticipation of biosimilar approvals |
| 2025 |
$6,500 |
Slight decline as biosimilar activities intensify |
Slight downward pressure begins |
| 2026 |
$6,200 |
Price declines accelerate pre-patent expiry |
Biosimilars pending approval |
| 2027 |
$5,800 |
Biosimilar launch expected in US |
Price reduction ranges 25-30% |
| 2028+ |
$4,200 - $4,800 |
Extended biosimilar competition, further discounts |
Continued market share erosion |
Long-term Outlook
Post-2027 biosimilar competition will reduce prices substantially. The combination of patent expiries and increasing biosimilar acceptance could lead to a decline of approximately 50-60% in list prices over a 5-year period.
Key Market Drivers and Risks
-
Drivers
- Growing multiple myeloma incidence, approximately 34,000 cases annually in the US [3].
- Expanding indications and combination therapy approvals.
- Increasing adoption due to superior efficacy compared to older therapies.
-
Risks
- Biosimilar biosimilar entry and price erosion.
- Reimbursement policy changes.
- New therapeutics superseding current standards.
Key Takeaways
- Darzalex (NDC 00591-3220) is a leading multiple myeloma agent with ~40% market share.
- Pricing stands at around $6,800 per 100 mg vial, with high treatment costs.
- Patent expiration in 2027 will catalyze biosimilar entry, reducing prices by roughly 25-30% initially.
- Long-term pricing is expected to decline further, potentially by over 50% within five years post-biosimilar launch.
- The market's growth is supported by increased diagnosis rates and ongoing clinical trials, but will face continued pressure from biosimilar competition and policy shifts.
FAQs
1. What factors most influence Darzalex's market price?
Patent expiration, biosimilar entry, reimbursement policies, and clinical adoption rates.
2. When are biosimilars for Darzalex expected to enter the US market?
Post-2027, with filings underway and approvals potentially by late 2027 or early 2028.
3. How does Darzalex compare to its competitors in terms of efficacy?
Darzalex demonstrates higher response rates and longer progression-free survival in multiple myeloma patients compared to some alternatives but varies with combination regimens.
4. What is the potential market size for Darzalex in the next five years?
Market size will depend on pricing, penetration, and indication expansion; revenue could remain near $4 billion annually pre-biosimilar entry, declining thereafter.
5. How are regulatory changes expected to impact future pricing?
Stricter reimbursement policies and emphasis on value-based pricing could accelerate discounts and influence demand.
Sources
[1] U.S. FDA. (2015). Darzalex (daratumumab) Approval Letter.
[2] U.S. Patent and Trademark Office. (2022). Patent expiry dates for Darzalex.
[3] American Cancer Society. (2022). Cancer statistics, multiple myeloma.
