Last updated: February 20, 2026
What is NDC 00591-2474?
NDC 00591-2474 corresponds to a specific formulation of a pharmaceutical product approved by the FDA. Based on the latest available data, this NDC refers to Rituximab (brand name Rituxan) in an intravenous formulation used primarily for treating non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and other autoimmune diseases.
Market Overview
Market Size and Demand
- The global rituximab market was valued at approximately USD 3.5 billion in 2022.
- Compound annual growth rate (CAGR) from 2022 to 2028 is projected at around 7.2%.
Key Drivers
- Increasing prevalence of autoimmune diseases such as rheumatoid arthritis.
- Rising incidence of non-Hodgkin lymphoma and chronic lymphocytic leukemia.
- Expanding indications for rituximab, including new autoimmune conditions.
- Growing adoption of biosimilars, driving competitive pricing.
Competitive Landscape
| Player |
Market Share (Estimate) |
Product Focus |
Noteworthy Developments |
| Roche (Rituxan) |
60% |
First-mover monoclonal antibody |
Launch of biosimilar in certain markets |
| Sandoz (Rixathon) |
15% |
Biosimilar to Rituxan |
Price competition, expanding access |
| Celltrion (Truxima) |
10% |
Biosimilar |
Approved in U.S. and EU |
| Other biosimilars |
15% |
Various |
Competitive pricing, patent expirations |
Pricing Trends and Regulatory Impacts
- Originator Rituxan's average wholesale price (AWP) in 2022 was roughly USD 5,500 per vial.
- Biosimilar versions launched in 2019-2021 typically priced at 20-30% below originator.
- Price erosion accelerated post-biosimilar entry, with discounts reaching 40-50% in some markets.
Price Projections
Short-term (Next 1-2 Years)
- Originator Price: Expected to decrease marginally, stabilizing around USD 4,800–5,000 per vial due to market saturation.
- Biosimilar Price: Anticipated to be USD 3,500–4,000 per vial in the U.S. and European markets.
- Market Share Redistribution: Biosimilars expected to account for over 40% of prescriptions by 2024.
Mid- to Long-term (Next 3–5 Years)
- Prices of biosimilars will likely decrease further, reaching USD 2,500–3,000 per vial.
- Sustained growth will depend on patent expirations, regulatory approvals, and uptake in emerging markets.
- Innovative formulations or combination therapies could impact price dynamics.
Factors Influencing Pricing
- Regulatory decisions regarding biosimilar approval and interchangeability.
- Reimbursement policies and insurance coverage.
- Competition among biosimilar manufacturers.
- Cost of manufacturing and supply chain factors.
Revenue Potential
- Firms controlling biosimilar patents and market access are positioned to capture significant revenue.
- Expected global sales for rituximab (including biosimilars) could reach USD 4–5 billion annually by 2026.
- Originator sales may decline by 25–35% over the next 3 years due to biosimilar competition.
Key Takeaways
- NDC 00591-2474, representing rituximab, faces increasing pricing pressure from biosimilars.
- Market demand remains steady due to high prevalence of target indications.
- Price erosion is expected to continue, with biosimilars attaining 40–50% discounts over originator brands within 2 years.
- Long-term revenue growth depends on regulatory approvals, biosimilar penetration, and emerging indications.
- Manufacturers should monitor patent cliffs and biosimilar authorization timelines to optimize market strategy.
FAQs
What factors most significantly affect the price of rituximab?
Patent expiration, biosimilar approvals, market competition, insurance reimbursement policies, and manufacturing costs.
How do biosimilars impact the market for NDC 00591-2474?
They increase competition, reduce prices, and share market volume with the originator product, leading to overall price declines.
What are the key regions influencing rituximab pricing?
United States, European Union, and emerging markets such as China and India greatly influence global pricing strategies.
When are major patent expirations set for rituximab?
The originator patent expired in the U.S. in 2018; subsequent patent extensions were contested, with some patents expiring by 2023, opening further biosimilar opportunities.
How might upcoming regulatory policies affect prices?
Interchangeability decisions, formulary restrictions, and reimbursement policies can either constrain or expand biosimilar adoption, impacting prices.
References
- MarketWatch. (2023). Global Rituximab Market Size, Share & Trends Analysis. https://www.marketwatch.com/
- EvaluatePharma. (2022). 2022 World Preview: Outlook for Pharmaceuticals. https://www.evaluate.com/
- Food and Drug Administration (FDA). (2021). Biosimilar and Interchangeable Products. https://www.fda.gov
- IQVIA. (2022). Biopharmaceutical Pricing Trends. https://www.iqvia.com
- European Medicines Agency (EMA). (2022). Biosimilar medicines. https://www.ema.europa.eu
