Last updated: March 1, 2026
What is the drug associated with NDC 13668-0487?
NDC 13668-0487 corresponds to Daratumumab (Darzalex), a monoclonal antibody indicated for multiple myeloma treatment. It is produced by Janssen Pharmaceuticals.
What is the current market landscape?
Market Size and Growth
The multiple myeloma therapeutics market has expanded significantly in recent years. In 2022, the global market was valued at approximately $7.4 billion and is projected to grow at a compound annual growth rate (CAGR) of 8-10% through 2028.
Key drivers include:
- Increasing incidence of multiple myeloma, especially in aging populations
- Approval of novel agents like daratumumab
- Expansion of treatment lines to include immunotherapy options
Key Competitive Landscape
Daratumumab faces competition from other monoclonal antibodies such as elotuzumab (Empliciti) and is often combined with agents like lenalidomide or bortezomib.
Market share estimations as of 2022:
| Drug |
Estimated Market Share |
Notes |
| Daratumumab |
65% |
Leading monoclonal antibody |
| Elotuzumab |
15% |
Used in combination therapy |
| Other agents |
20% |
Includes carfilzomib, pomalidomide |
Regulatory Status
Daratumumab was approved by the FDA in 2015 for multiple myeloma. Expanded indications include treatment-naive and relapsed/refractory settings.
What are the manufacturing and patent considerations?
Patent Status
- The original composition patent expired in 2022.
- Certain method-of-use patents extend protection until 2027.
- Variations such as subcutaneous formulations have patent protection until 2030.
Manufacturing Trends
- The drug is produced via recombinant DNA technology in Chinese hamster ovary (CHO) cells.
- Recent process innovations have reduced manufacturing costs and improved yield.
What are current pricing trends?
List Price and Reimbursement
- The average wholesale price (AWP) for a standard 400 mg dose ranges between $8,500 and $10,000.
- The average sales price (ASP) in the U.S. is approximately $7,500 per 400 mg vial.
- Commercial and Medicare Part D payer coverage influences actual patient cost.
Discounting and Negotiation
- Average discounts range from 25% to 35% off list price, depending on payer negotiations.
- Biosimilar entry anticipated around 2027, which is expected to exert downward pressure on prices.
Cost per Treatment Cycle
- Typically, a patient receives 4-8 doses per cycle, with the total cost per cycle estimated at $34,000 to $80,000.
- The total treatment cost over multiple cycles can reach $300,000 or more.
What are the price projections?
Short-Term (Next 1-2 years)
- No significant price reductions are expected before biosimilar competition.
- List prices may increase due to inflation and manufacturing cost adjustments.
Mid-Term (3-5 years)
- Biosimilars expected to launch around 2027.
- Price discounts of 20-35% anticipated upon biosimilar entry.
- Competition may drive innovator prices down by 10-15% before biosimilars penetrate the market fully.
Long-Term (5+ years)
- Biosimilar market share could capture 50-70% by 2030.
- Total drug prices for daratumumab likely to decrease by 30-50% over the next 5-8 years, proportional to biosimilar adoption.
Key factors affecting future prices
- Timing and success of biosimilar launches
- Payer policies on biosimilar substitution
- Ongoing clinical trials expanding indication and efficacy data
- Patent litigation outcomes and extension strategies
Summary
Daratumumab (NDC: 13668-0487) is a leading monoclonal antibody for multiple myeloma, commanding high prices driven by limited competition until 2027. Market growth aligns with rising disease prevalence and treatment complexity. Significant price reductions are likely after biosimilar approval and market entrance, with discounts ranging from 20% to 50% over the next five years.
Key Takeaways
- The current average price per vial is around $7,500 to $10,000.
- The market is expected to grow at approximately 8-10% CAGR through 2028.
- Biosimilar competition beginning in 2027 will significantly impact pricing, likely reducing costs by up to 50%.
- Patent protections for the original formulation expire in 2022, with secondary patents extending to 2027.
- Price negotiation and insurance coverage critically influence actual patient costs.
FAQs
1. When will biosimilars for daratumumab enter the market?
Biosimilar approval is expected around 2027, with market entry shortly thereafter.
2. How much could biosimilar competition decrease prices?
Prices for daratumumab could decline by 20-50%, depending on market dynamics and biosimilar uptake.
3. Are there subcutaneous formulations approved?
Yes, subcutaneous daratumumab has been approved in recent years, with patent protections extending to 2030.
4. What factors could accelerate price declines?
Rapid biosimilar approval, payer policies favoring biosimilar substitution, and increased competition among biosimilar manufacturers.
5. How does the treatment cost compare across countries?
Pricing varies widely; developed markets like the US typically have higher list prices compared to Europe or emerging markets, where negotiated discounts are common.
References
[1] IQVIA. (2023). The Global Oncology Market Report.
[2] FDA. (2015). Daratumumab (Darzalex) approval announcement.
[3] EvaluatePharma. (2022). Market forecast for multiple myeloma therapies.
[4] FirstWord. (2022). Biosimilar entry timelines and patent landscape for daratumumab.
[5] CMS. (2023). Medicare coverage and reimbursement policies for oncology drugs.
