Last updated: February 14, 2026
mmary:
The drug with NDC 00378-2920 is Daratumumab, marketed as Darzalex. It remains a dominant monoclonal antibody indicated for multiple myeloma. The market environment shows steady demand upheld by ongoing clinical data and expanding indications. Pricing trends indicate stable list prices with upwards pressure from inflation and supply chain factors. Future revenue projections depend on approval expansions, biosimilar developments, and payer negotiations.
Market Overview of NDC 00378-2920 (Daratumumab):
Product Profile:
Daratumumab is a monoclonal antibody targeting CD38. It is approved for multiple myeloma, including newly diagnosed and relapsed/refractory cases. Launched by Janssen Pharmaceuticals in 2015, it is administered via intravenous infusion. The drug’s approval has expanded from monotherapy to combination therapies with proteasome inhibitors and immunomodulatory agents.
Market Size & Sales Performance:
- Estimated US sales in 2022: approximately $3.2 billion (IQVIA data).
- Global sales remain profitable, with Europe representing a substantial market segment.
- Market growth driven by expanding indications, including early-line settings.
Competitive Landscape:
- Primary competitors include Selinexor (Xpovio), Elotuzumab (Empliciti), and emerging biosimilars.
- Biosimilar development is in early phases; no biosimilar approved yet in the US, although global biosimilars are under development (e.g., in India and Europe).
Regulatory & Market Expansion Points:
- Approved in over 70 countries.
- Clinical trials ongoing for maintenance therapy and earlier treatment lines.
- Patent coverage through 2028–2030, with generic competition expected thereafter.
Pricing Trends & Projections:
Current Price Points:
- List price per infusion (USA): approximately $4,600 - $5,200, depending on dosage and formulation.
- Average wholesale acquisition cost (WAC): about $112,000-$130,000 per year per patient for standard treatment courses.
- Insurance and PBMs typically negotiate discounts, reducing net prices.
Price Stability & Drivers:
- No major recent price reductions since launch.
- Continued demand supports pricing; payer negotiations maintain favorable reimbursement margins.
- Potential for price increases tied to inflation and manufacturing costs.
Early 2023 Forecasts:
- List prices are projected to increase annually by approximately 3–5%.
- The influence of biosimilar entries expected post-2030 could compel price adjustments downward, especially under competitive pressures.
- Market exclusivity through patents until 2028, after which biosimilar competition could reduce prices by 20–40%.
Market Dynamics & Pricing Pressure:
- The US CMS and private insurers seek to contain drug costs, potentially leading to tighter formulary restrictions or rebates for Daratumumab.
- International markets face additional pricing controls, notably in European countries where negotiating authorities can lower prices by 10–20% relative to US levels.
Future Revenue & Price Outlooks:
| Year |
Estimated US Sales (USD) |
Expected Price Changes |
Competitive Risks |
| 2023 |
$3.2 billion |
+3% |
Biosimilar threat delayed but imminent post-2028 |
| 2024 |
$3.3 billion |
+3–4% |
Reimbursement adjustments |
| 2025 |
$3.4 billion |
+2–3% |
Market saturation in key indications |
| 2026 |
$3.5 billion |
+2% |
Entry of biosimilars in other markets |
Note: External factors such as new indications, combination regimens, or regulatory shifts could influence the market size and prices.
Key Takeaways:
- Daratumumab (NDC 00378-2920) maintains a strong market position with annual sales exceeding $3 billion in the US.
- List prices have remained stable with slight increases; anticipated to grow by 3–5% yearly until biosimilar competition impacts pricing after 2028.
- Reimbursement strategies and negotiations will significantly influence actual net prices.
- Biosimilar competition will likely reduce prices by 20–40% globally after patent expiry.
- Expansion into earlier lines and additional indications can sustain revenue growth despite patent cliffs.
FAQs:
-
What factors influence Daratumumab’s pricing in the US?
Reimbursement negotiations, demand, manufacturing costs, and market exclusivity impact list and net prices.
-
When are biosimilars expected to enter the US market?
Bio similarity patent protections expire around 2028–2030, with biosimilars likely launching shortly thereafter.
-
How will increasing competition affect the drug’s future revenue?
Prices are expected to decrease by 20–40% post-biosimilar entry, though volume may offset some revenue loss if expanded indications are approved.
-
Are there any regulatory changes that could impact prices or the market?
Yes, potential government measures for drug price regulation, approval of new indications, or patent disputes could influence pricing and market share.
-
What are the strategic options for sustaining profitability?
Expanding indications, establishing long-term payer agreements, and investing in biosimilar R&D are key options.
Sources:
[1] IQVIA, "US Prescription Drug Sales Data," 2022.
[2] FDA, "Daratumumab (Darzalex) Label," 2022.
[3] European Medicines Agency, "Daratumumab Approval," 2022.
[4] PatentScope, "Patent Data for Daratumumab," 2022.
