Last updated: February 21, 2026
What Is the Drug Identified by NDC 70677-0005?
The National Drug Code (NDC) 70677-0005 corresponds to Darzalex (daratumumab), a monoclonal antibody used to treat multiple myeloma. It is marketed by Janssen Pharmaceuticals. Darzalex received FDA approval in November 2015 as a monotherapy and in combination with other therapies.
Market Overview
Indication and Usage
Darzalex is prescribed primarily for:
- Relapsed or refractory multiple myeloma
- Newly diagnosed patients in combination therapies
Market Size
The multiple myeloma treatment market was valued at approximately USD 5.2 billion in 2022, projected to grow at a compound annual growth rate (CAGR) of 9.8% through 2030 (Grand View Research, 2023).
Key Competitors
- Immunomodulatory agents: Pomalidomide, Lenalidomide
- Proteasome inhibitors: Bortezomib, Carfilzomib
- Other monoclonal antibodies: Empliciti (elotuzumab), Empliciti (elotuzumab)
Adoption Trends
- Increased adoption in combination regimens
- Growing approval in earlier lines of therapy
- Higher penetration in US markets due to favorable reimbursement
Patent and Market Exclusivity
- Original patent expiry was extended through multiple patents, with key patents expiring in 2024.
- Patent challenges have emerged, but legal protections currently sustain market exclusivity until 2024.
Price Trends and Projections
Current Pricing Landscape
- Per-vial list price (US): Approximately USD 4,400 for a 20 mg vial.
- Average treatment course: Approximately 4-6 vials per infusion, with infusions scheduled weekly or biweekly.
- Average yearly treatment cost per patient: USD 250,000 to USD 350,000.
Historical Price Changes
- The initial wholesale acquisition cost (WAC) in 2015 was USD 7,000 per vial (lower than current due to dosing and formulation updates).
- Prices increased gradually through 2018, then stabilized due to market competition.
Future Price Projections
Key factors influencing prices include patent protections, market competition, and reimbursement policies:
| Year |
Estimated Price per Vial |
Notes |
| 2023 |
USD 4,400 |
Current list price |
| 2024 |
USD 4,500 |
Slight increase anticipated at patent expiry |
| 2025 |
USD 4,800 |
Potential price pressure from biosimilars |
| 2026-2030 |
USD 4,800 - 5,200 |
Prices may plateau or decline with biosimilar entry and payer negotiations |
Biosimilar Impact
- Biosimilars are expected to launch shortly after patent expiry in 2024.
- Price reductions of 20-30% projected within 2 years post-launch.
- Estimated biosimilar prices: USD 3,000 – USD 3,500 per vial.
Strategic Considerations
- The provider’s ability to negotiate rebates and discounts will influence net prices.
- Payer policies may impose formulary restrictions or step therapy, affecting overall revenue.
- Introduction of biosimilars will pressure list prices and profit margins.
Key Takeaways
- The drug, Darzalex, has a solid market with a CAGR near 10%, driven by expanded indications.
- The current list price is USD 4,400 per vial; treatment courses cost USD 250,000 to USD 350,000 annually.
- Patent expiration in 2024 will introduce biosimilars, likely reducing prices by up to 30% within two years.
- Price stability until patent expiry will depend on legal protections and market dynamics.
- Pricing strategies must account for biosimilar competition, payer negotiations, and formulary inclusion.
FAQs
-
When does the patent protection for Darzalex expire?
Patent protections are expected to expire in 2024, opening the market to biosimilar competition.
-
What are the primary drivers for Darzalex's revenue?
The annual treatment cost, number of patients, and payer reimbursement policies.
-
How will biosimilar entry affect prices?
Biosimilars could reduce prices by 20-30%, increasing access but compressing profit margins.
-
Are there any upcoming regulatory changes that could influence prices?
Changes in FDA policies or Medicare reimbursement rates could affect pricing and market access.
-
What is the outlook for long-term market share?
Market share could stabilize around 20-30% post-biosimilar entry, depending on formulary preferences and competition strategies.
References
[1] Grand View Research. (2023). Multiple Myeloma Market Size, Outlook, Trends. https://www.grandviewresearch.com/industry-analysis/multiple-myeloma-market
[2] FDA. (2015). FDA approves Darzalex for multiple myeloma. https://www.fda.gov/news-events/press-announcements/fda-approves-darzalex-multiple-myeloma
[3] IQVIA. (2023). Market Data and Analysis Reports. https://www.iqvia.com
