Last updated: February 21, 2026
What is the Drug and Its Market Context?
NDC 54436-0275 refers to an injectable form of Daratumumab (marketed as Darzalex), a monoclonal antibody used to treat multiple myeloma. Approved by the FDA in 2015, Daratumumab has become a cornerstone therapy for relapsed or refractory multiple myeloma, often used in combination with other agents.
The drug's global sales exceeded $4 billion in 2022, driven by expanded indications and increased adoption in treatment protocols. Its main competitors include Elotuzumab (Empliciti) and Carfilzomib (Kyprolis), with the multiple myeloma market expanding at a CAGR of 12.3% over 2020–2025.
Market Size and Revenue Drivers
| Parameter |
Details |
| Global multiple myeloma market size (2022) |
Approx. $12 billion |
| Daratumumab's market share (2022) |
Estimated at 33%; revenue over $4 billion |
| Year-over-year revenue growth (2020–2022) |
Approx. 20% annually |
| Key growth catalysts |
Expanded indications, new combination regimens, and increased diagnosis rates |
Pricing Overview and Trends
Current Pricing (2023)
| Region |
List Price per 1,800 mg Dose |
Cost per Treatment Cycle (6 doses) |
Notes |
| U.S. |
~$8,300 |
~$49,800 |
List price; actual billing varies by insurer |
| Europe |
€7,000 (~$7,600) |
€42,000 (~$45,600) |
Prices vary by country |
| Canada |
CAD 11,000 (~$8,250) |
CAD 66,000 (~$49,500) |
Includes negotiated pricing |
Pricing Dynamics
- List prices have remained relatively stable over the past three years.
- Hospitals and insurers negotiate discounts averaging 20–35% off list prices.
- Introduction of biosimilars is limited due to patent protections and technical complexity.
Patent Landscape and Biosimilar Competition
Daratumumab's primary patents expired in the U.S. in 2025. Pending biosimilars could enter the market by 2026–2027, potentially reducing price levels by 20–40%.
Patent Expiration and Biosimilar Outlook
| Year |
Patent Expiry |
Expected Biosimilar Entry |
Price Impact Estimate |
| 2025 |
2025 |
May enter by 2026 |
20–30% reduction |
| 2027 |
2027 |
Additional biosimilars |
Up to 40% reduction |
Future Price Projections
| Year |
Expected Price per Dose |
Rationale |
| 2024 |
~$8,200 |
Slight decrease with inflation, no biosimilars yet |
| 2025 |
~$8,100 |
Pending patent expiry; slight downward pressure |
| 2026 |
~$6,600–$7,000 |
Entry of first biosimilar; competitive price setting |
| 2027 |
~$5,200–$6,000 |
Increased biosimilar competition; potential tiered pricing strategies |
Implications for Stakeholders
- Pharmaceutical companies: Biosimilar entrants pose significant pricing pressure post-2025.
- Payers: Negotiations will drive discounts and formulary placement.
- Investors: Valuations should incorporate patent cliffs and biosimilar timelines.
Regulatory and Policy Factors
- Biosimilar approval processes vary across regions, influencing market entry timing.
- U.S. FDA policy supports expedited pathways for biosimilars, but patent litigation may delay entry [1].
Key Takeaways
- NDC 54436-0275 (Daratumumab) is a leading multiple myeloma treatment with over $4 billion revenue in 2022.
- List prices remain stable, but discounts and negotiated prices are common.
- Patent expiry in 2025 opens a window for biosimilar entry, expected to substantially reduce prices by 2026–2027.
- The market is poised for price declines driven by biosimilar competition, with potential reductions of 20–40%.
FAQs
-
When does the patent for Daratumumab expire?
Patent expiration in the U.S. is set for 2025, enabling biosimilar development and approval thereafter.
-
How will biosimilar entry affect the price?
Biosimilars are expected to reduce prices by 20–40%, depending on market competition and regulatory approval speed.
-
What is the current price for Daratumumab in the U.S.?
The list price is approximately $8,300 per 1,800 mg dose, with actual prices negotiated down by payers.
-
What factors influence the price of Daratumumab outside the U.S.?
Pricing is affected by regional regulations, negotiations, discounts, and healthcare policies.
-
Which companies are preparing biosimilars for Daratumumab?
Multiple companies, including Samsung Bioepis and Sandoz, are developing biosimilars expected to launch around 2026–2027.
References
[1] Food and Drug Administration. (2022). Biosimilars. https://www.fda.gov/drugs/biosimilars
