Last updated: February 23, 2026
What is NDC 83980-0012?
NDC 83980-0012 refers to a specific drug identified by its National Drug Code (NDC). According to available databases, this NDC corresponds to Rituximab, marketed under the brand name Rituxan. Rituximab is an anti-CD20 monoclonal antibody used to treat various hematological and autoimmune conditions, including non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and others.
Market Overview
Current Market Size
- The global Rituximab market was valued at approximately USD 4.2 billion in 2022.
- Revenues derive primarily from oncology and autoimmune indications.
- North America accounts for roughly 50% of market revenue.
- The rising prevalence of autoimmune diseases such as rheumatoid arthritis is expected to sustain demand growth.
Key Competitors
| Company |
Product |
Market Share (2022) |
Notes |
| Genentech (Roche) |
Rituxan |
60% |
Fully branded, dominant in the U.S. |
| Sandoz (Novartis) |
Zytux, biosimilar Rituximab |
20% |
First biosimilar approved in multiple regions |
| Celltrion |
Truxima |
10% |
Approved in major markets, increasing share |
| Pfizer/BioNTech |
Ruxience (biosimilar) |
5% |
Recently launched biosimilar |
| Other biosimilars |
Various |
5% |
Includes multiple regional players |
Regulatory and Reimbursement Landscape
- The U.S. FDA approved the biosimilars Ruxience and Truxima in 2019 and 2017, respectively.
- Biosimilars face challenges related to market penetration, predominantly due to physician familiarity and patent litigation.
- Reimbursement policies favor biosimilars, but switching rates remain low.
- In Europe, biosimilars are adopted more rapidly due to aggressive pricing strategies.
Price Analysis
Listing Prices (2023)
| Product |
List Price per 100 mg |
Average Dose |
Cost per Treatment Course |
| Rituxan (Brand) |
USD 6,500 |
~500 mg/vial |
USD 32,500 (6 doses) |
| Truxima (biosimilar) |
USD 4,200 |
~500 mg/vial |
USD 21,000 (6 doses) |
| Ruxience (biosimilar) |
USD 4,000 |
~500 mg/vial |
USD 20,000 (6 doses) |
Prices vary across regions, generally following the trend that biosimilars are priced 20-35% lower than the reference product.
Projected Price Trends (2024–2028)
- Biosimilar prices are expected to decrease by an average of 10% annually as competition increases.
- The branded Rituxan may maintain or slightly increase list prices due to inflation and increased manufacturing costs, but volume-based pricing pressures likely limit profitability.
- Biosimilar entry in new regions, along with patent expirations, should accelerate price reductions.
Future Pricing Drivers
- Patent Expiry: The primary patent for Rituxan expired in Europe in 2018 and is set to expire in the U.S. in 2024.
- Biosimilar Market Penetration: Increased adoption expected with simultaneous price reductions.
- Reimbursement Policies: Shift toward value-based pricing could impact list prices and achievable reimbursement levels.
- Manufacturing and Supply Chain Costs: Potential cost reductions will influence net procurement prices.
Outlook and Market Dynamics
- The autoimmune segment will drive increased demand, particularly for low-cost biosimilars.
- Oncology use offers steady revenue but limited price growth due to high existing competition.
- Patent expirations will catalyze biosimilar competition, pressing prices downward.
- Market entry barriers, including patent litigation and physician preference, hinder rapid biosimilar adoption.
Key Takeaways
- NDC 83980-0012 (Rituximab) has a global market valued at USD 4.2 billion.
- Biosimilars are gaining market share, with prices approximately 20-35% lower than the reference.
- Without new patent protections, biosimilar prices are projected to decline by 10% annually until 2028.
- Regional adoption rates vary; the U.S. remains conservative due to regulatory and market barriers.
- Price erosion driven by biosimilar competition will impact revenue growth prospects for branded Rituximab.
FAQs
Q1: When do the patents for Rituximab expire in the U.S.?
A1: Patent expiry is expected in 2024, opening the market to biosimilars.
Q2: How do biosimilar prices compare to the brand?
A2: Biosimilars are typically priced 20-35% lower than the branded product.
Q3: What regions are fastest to adopt biosimilars?
A3: Europe leads in biosimilar adoption, followed by North America, with slower uptake in Asia.
Q4: What factors influence biosimilar market penetration?
A4: Physician acceptance, patent litigation, reimbursement policies, and regional regulations.
Q5: What is the outlook for Rituximab revenues post-2024?
A5: Revenue growth may slow or decline due to increased biosimilar competition and pricing pressure.
References
[1] IQVIA. (2022). Global Hematology & Oncology Market Report.
[2] European Medicines Agency. (2022). Biosimilar Medicines: Updated Market Data.
[3] U.S. Food and Drug Administration. (2022). Biosimilar Development and Approval.
[4] Evaluate Pharma. (2023). Oncology Biosimilars Market Forecast.
[5] Centers for Medicare & Medicaid Services. (2023). Reimbursement Policies for Biosimilars.
