Last updated: February 17, 2026
Product Overview
NDC 13107-0046 is the Drug Listing Number for Rituximab (Brand: Rituxan), a monoclonal antibody used to treat non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and other autoimmune diseases. It is marketed by Genentech, a division of Roche.
Market Landscape
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Indications & Usage
- Oncologic: Non-Hodgkin's lymphoma, chronic lymphocytic leukemia
- Autoimmune: Rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis
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Market Size
- Global monoclonal antibody market projected at $180 billion in 2023 (source: MarketsandMarkets).
- Rituximab accounts for approximately 10% of this segment, with annual sales around $17-20 billion globally.
- Key markets include U.S., Europe, and Japan; U.S. accounts for ~50% of sales.
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Competitive Landscape
- Biosimilars: Several biosimilars approved in the U.S. and Europe, such as Pfizer's Truxima and Celltrion's CT-P10, entered the U.S. market after patent expiration.
- Innovation: Next-generation anti-CD20 therapies in clinical development may threaten market share of existing Rituximab formulations.
- Pricing pressure is heightened due to biosimilar competition and payer negotiations.
Regulatory & Patent Timeline
- Original patent expired in the U.S. in 2018, leading to biosimilar entry.
- Patent litigations concluded in 2022, clearing pathway for biosimilar competition.
- Additional patents on formulation and methods extend exclusivity until 2025-2027 in some jurisdictions.
Pricing Trends and Projections
Future Drivers
Summary Table: Pricing and Market Movements (2023–2027)
| Year |
Average Vial Price (USD) |
Estimated Market Share (Brand vs. Biosimilar) |
Total Revenue Impact |
| 2023 |
$2,400–$3,000 |
Brand (~80%), Biosimilar (~20%) |
Baseline |
| 2024 |
$2,100–$2,700 |
Brand (~70%), Biosimilar (~30%) |
Moderate decline |
| 2025 |
$1,700–$2,400 |
Biosimilar (~50–60%) |
Significant decline |
| 2026 |
$1,600–$2,200 |
Biosimilar (~70%) |
Continued decline |
| 2027 |
$1,600–$2,200 |
Biosimilar (~70–80%) |
Reduced total revenue |
Key Takeaways
- Market size remains large due to multiple indications.
- Biosimilar competition is expected to reduce prices by 15-25% over four years.
- Revenue projections must account for increased biosimilar market penetration and declining per-unit prices.
- Regulatory, patent, and clinical development factors heavily influence the market dynamics.
- The manufacturer's ability to retain market share depends on patent protection, contractual relationships, and product differentiation.
FAQs
Q1: When will biosimilars for NDC 13107-0046 become widely available in the U.S.?
A1: Biosimilars began entering the U.S. market post-patent expiration in 2022, with widespread adoption expected by 2024–2025.
Q2: How does biosimilar entry affect total revenue from Rituximab?
A2: Biosimilar entry typically reduces prices and increases volume competition, leading to an overall decline in revenue, estimated at 20–40% per year post-entry.
Q3: Which markets have the highest potential for price reductions?
A3: The U.S. and Europe are priority markets, with price reductions driven by biosimilar competition and payer negotiations.
Q4: Are there newer drugs threatening Rituximab’s market share?
A4: Yes. Next-generation anti-CD20 agents and targeted therapies are in development, potentially impacting market share in specific indications.
Q5: How long will Rituximab retain market exclusivity?
A5: Patent protections extend into 2025–2027 in key jurisdictions, after which biosimilar competition is expected to dominate.
Sources
[1] MarketsandMarkets. "Monoclonal Antibody Market by Type." 2023.
[2] FDA. "Biosimilar Approvals and Market Entry." 2022.
[3] IQVIA. "Global Oncology Market Trends." 2023.
[4] Pfizer, Celltrion. "Biosimilar Product Launch Announcements." 2022-2023.
[5] NIH Reports. "Patent and Regulation Timeline for Monoclonal Antibodies." 2022.
