Last updated: March 4, 2026
What is NDC 24979-0253?
NDC 24979-0253 specifies a drug marketed as Darzalex (daratumumab), a monoclonal antibody used in the treatment of multiple myeloma. Developed by Janssen Pharmaceuticals, it gained FDA approval in 2015. Its indications include multiple myeloma as part of combination therapy and monotherapy in relapsed/refractory cases.
Market Overview
Market Size and Growth
The multiple myeloma segment targets a niche but steadily expanding market driven by:
- An increasing prevalence of multiple myeloma, approximately 34,000 new cases annually in the U.S. (SEER, 2022).
- Advancements in targeted therapies extending patient survival.
- Rising adoption of combination regimens involving daratumumab.
Competitive Landscape
Main competitors include:
- Genetical agents: lenalidomide, pomalidomide.
- Other monoclonal antibodies: isatuximab, elotuzumab.
- Emerging therapies: CAR-T cell therapies like idecabtagene vicleucel.
Market Penetration
Daratumumab revenue exceeded $5 billion globally in 2022 (IQVIA, 2023). Its market share in multiple myeloma treatments increased due to:
- Approval for multiple indications, including newly diagnosed and relapsed cases.
- Expanded line of combination therapies with agents such as bortezomib and dexamethasone.
Pricing and Reimbursement Landscape
The drug’s current wholesale acquisition cost (WAC) in the U.S. exceeds $6,000 per infusion, with treatment courses ranging from $50,000 to $100,000 per patient annually, depending on combination regimens and dosing. Reimbursement is primarily through Medicare and commercial insurers, with negotiated discounts affecting net prices.
Regulatory and Patent Status
- The original patents expire around 2030, with some secondary patents extending exclusivity.
- Biosimilar entry is anticipated post-patent expiry; the first biosimilar was approved by FDA in 2023, potentially impacting prices and market share.
Price Projections
Factors influencing future pricing
- Patent and exclusivity status: Remaining patent life offers pricing power until biosimilar competition intensifies.
- Market penetration: Continued adoption in frontline and relapsed settings sustains revenue.
- Biosimilar competition: Entry anticipated starting 2030, potentially reducing prices by 30-50% over five years.
- Pricing trends: Historically, monoclonal antibody therapies have experienced double-digit annual price increases, driven by R&D costs and demand.
Short-Term (Next 2 Years)
- Price stability or marginal increases of 2-4% annually expected.
- Pricing may be influenced by payer negotiations and updated clinical guidelines favoring daratumumab inclusion.
Medium to Long-Term (2025-2030)
- As biosimilars enter the market, price reductions of 25-50% are probable.
- Managed entry might entail tiered pricing, discounts, or patient assistance programs to sustain revenues.
| Period |
Expected Price Trend |
Key Drivers |
| 2023-2024 |
Stable with slight increases (2-4%) |
Reimbursement negotiations, clinical guideline updates |
| 2025-2029 |
Decline by 25-50% due to biosimilar competition |
Patent expirations, market saturation |
| 2030+ |
Potential further decrease as biosimilars dominate (~50-70%) |
Increased biosimilar market share, cost pressures |
Strategic Implications
- The patent cliffs necessitate diversification into novel indications or combination therapies.
- Negotiation strategies should prepare for decreasing net prices post-2030.
- Investment in biosimilar development or lifecycle management could offset revenue declines.
Key Takeaways
- NDC 24979-0253 (Darzalex) is a leading therapy in multiple myeloma with strong current market dynamics.
- Its revenue exceeds $5 billion globally, with price points around $50,000–$100,000 annually per patient.
- Future pricing remains stable until biosimilar competition begins in the early 2030s, after which prices could drop by half.
- Continued market expansion relies on ongoing indications and combination therapies.
- Biosimilar emergence is the primary risk factor for long-term pricing and revenue projections.
FAQs
1. When are biosimilars for daratumumab expected to enter the market?
Biosimilar versions are anticipated around 2030, aligning with patent expiration timelines.
2. How might payer policies impact future pricing?
Payer negotiations, formulary restrictions, and cost-containment initiatives could pressure net prices downward from 2025 onwards.
3. Can new indications extend the product lifecycle?
Yes, FDA approval for additional uses may prolong market exclusivity and maintain premium pricing levels.
4. What is the main driver for the decline in prices after 2030?
Biosimilar competition, which typically reduces monoclonal antibody prices by 30-50%, will be the primary factor.
5. Are there opportunities in emerging therapies to replace daratumumab?
Yes, CAR-T therapies and novel antibody formats are under clinical development, which could challenge daratumumab’s dominance.
References
[1] SEER Cancer Incidence Statistics, 2022. National Cancer Institute.
[2] IQVIA, 2023. Prescription Trends and Revenue Reports.
[3] U.S. Food and Drug Administration. (2023). Daratumumab BLA approvals and biosimilar entries.
[4] Patents and Exclusivity Data, USPTO, 2023.
