Last updated: February 16, 2026
What Is the Market Status for NDC 75907-0021?
NDC 75907-0021 corresponds to Darzalex (daratumumab). It is a monoclonal antibody used in multiple myeloma treatment. Approved by the FDA in 2015, Darzalex has solidified its standing as a key therapy in hematologic malignancy, especially in combination regimens for relapsed or refractory cases.
How Does Darzalex Perform in the Market?
Sales and Market Penetration
- Revenue: Darzalex global sales reached approximately $4.7 billion in 2022, up from around $4.2 billion in 2021 (1).
- Market Share: It holds around 50% of the monoclonal antibody market for multiple myeloma treatments, competing primarily with innovative drugs such as Ide-cel (idecabtagene vicleucel) and other bispecifics.
- Geographical Spread: The U.S. accounts for roughly 65% of revenues. European markets follow, with Asia-Pacific rapidly expanding.
Competitor Landscape
- Current competitors include Immunomodulatory agents and proteasome inhibitors, but Darzalex's unique mechanism of action sustains its market dominance.
- A generics entry is unlikely in the next 5 years due to patent protections. The key patent expiring in 2028 is the primary barrier for generics.
Regulatory and Approved Indications
- Originally approved for multiple myeloma, expanded indications include newly diagnosed and relapsed/refractory cases.
- FDA and EMA continue to authorize combination regimens, expanding market potential.
What Are the Price Projections for Darzalex?
Current Pricing
- In the U.S., the list price for Darzalex is approximately $6,350 per 1,800 mg vial.
- Treatment regimens often involve multiple doses, averaging about 12-16 vials per treatment course.
- Cost per patient per cycle ranges from $76,200 to $101,600, depending on dosing frequency.
Future Price Trends
-
Industry analysts project a slow decline in net prices due to:
- Price erosion from payer negotiations.
- Increased adoption of biosimilars (not yet available, but expected post-patent expiration).
- Introduction of more cost-effective combination therapies.
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A modest annual price decrease of 2-3% is anticipated through 2030, driven by market competition and healthcare policies focused on cost containment.
Market Dynamics Impacting Pricing
| Factor |
Impact |
| Patent expiration (~2028) |
Opens pathway for biosimilar competition, putting downward pressure on prices. |
| Volume growth |
Increased patient access may offset per-unit price declines. |
| Healthcare policy shifts |
Reimbursement reforms may incentivize formulary restrictions, influencing net prices. |
What Are the Major Risks and Opportunities?
Risks
- Patent cliff anticipated in 2028.
- Emergence of biosimilars could reduce revenue margins.
- Competition from CAR-T therapies and bispecific antibodies could capture market share.
Opportunities
- Expanding indications and combination protocols increase patient pool.
- Geographic expansion into emerging markets has growth potential.
- Ongoing clinical trials could validate new therapeutic uses.
Summary of Market and Pricing Outlook
| Aspect |
2023 Predictions |
2024–2030 Outlook |
| Revenue |
~$4.7 billion |
Steady growth with slight dips expected post-2028 due to biosimilar entry. |
| Pricing |
~$6,350 per vial, with 2-3% annual decline projected |
Continued decline, with potential stabilization in certain markets. |
| Market Share |
~50% among myeloma monoclonal antibodies |
Likely to decrease gradually post-2028. |
Key Takeaways
- Darzalex remains a leading therapy with over $4.7 billion in annual sales.
- Patent expiration in 2028 signals potential biosimilar competition.
- Price per vial is approximately $6,350; pricing is expected to decline modestly before biosimilar entry.
- Revenue growth will depend on label expansions and geographic market penetration.
- Competitive landscape shifts towards cell therapies may challenge Darzalex’s dominance but current pipeline investments sustain its position.
FAQs
1. When is Darzalex’s patent expiring?
Patents related to Darzalex are expected to expire around 2028, opening the market for biosimilars.
2. How does Darzalex compare price-wise to alternatives?
It is among the more expensive monoclonal antibody therapies, with costs around $6,350 per vial. Alternatives like Tecvayli (teclistamab) may differ in pricing and efficacy.
3. What are the primary drivers for future revenue?
Optimal growth relies on expanding indications, increasing treatment uptake, and geographic expansion, especially in Asia and emerging markets.
4. Will biosimilars significantly lower prices?
Potentially. Biosimilar entrants are expected to cause price erosion post-2028, with estimates suggesting a 20-30% reduction in net prices over 3–5 years.
5. Are there upcoming clinical trials that could impact the market?
Yes. Trials exploring Darzalex in earlier lines of therapy and combination regimens might extend its life cycle and expand indications.
References
[1] IQVIA, "Pharmaceutical Market Reports," 2022.
[2] Evaluate Pharma, "2023 Global Market Analysis."
[3] U.S. FDA Database, "Drug Approvals and Patent Status."
