Last updated: February 14, 2026
Overview
NDC 00641-6061 corresponds to a branded or generic pharmaceutical product. Based on available data, this NDC is identified as Rituximab (brand name: Rituxan), used primarily for treatments involving non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and other autoimmune diseases. Its market dynamics are influenced by patent status, competition, manufacturing costs, and regulatory approvals.
Market Landscape
1. Current Market Size
- The global Rituximab market was valued at approximately $7.1 billion in 2021. Projections indicate a compound annual growth rate (CAGR) of around 6% through 2030.
- The US accounted for nearly $3.2 billion of this market in 2021, driven by high prevalence of indications and reimbursement coverage.
2. Competitors and Market Share
- Original brand (Rituxan): Largest market share historically.
-
Biosimilars: Several biosimilars entered the U.S. market post patent-expiry in 2018, including:
- Truxima (Celltrion)
- Riabni (Amgen)
- Ruxience (Pfizer)
These biosimilars have reduced the price point of Rituximab by approximately 20-40% and increased market accessibility.
3. Patent and Regulatory Status
- Original patent for Rituxan expired in the U.S. in 2018.
- Multiple biosimilars approved by FDA (e.g., Truxima approved in 2018, Ruxience in 2019, Riabni in 2021).
- Patent litigations and exclusivity periods may influence the pace of biosimilar uptake.
Pricing Analysis
1. Current List Prices
| Product |
Approximate Wholesale Acquisition Cost (WAC) / Administration (per dose) |
Notes |
| Rituxan (Brand) |
$4,500–$5,200 |
Variations based on dose and region |
| Truxima (Biosimilar) |
15–25% lower than Rituxan |
Discounts vary by provider |
| Ruxience (Biosimilar) |
Similar price to Truxima |
Widely adopted in outpatient settings |
2. Price Trends
- Biosimilar introduction led to a decrease in Rituximab prices by up to 40%.
- Average per-dose reimbursement in the U.S. now ranges from $3,300 to $4,000.
- Expected further price erosion due to increased biosimilar penetration and competitive procurement.
Consumption and Revenue Projections
1. Usage Trends
- Estimated annual prescriptions: approximately 250,000–300,000 in the U.S.
- Predominant indications: Non-Hodgkin’s lymphoma and rheumatoid arthritis.
- Growth influenced by expanding indications and biosimilar acceptance.
2. Revenue Factors
- Market share of biosimilars is projected to reach 60–70% within five years.
- Price decreases will offset volume increases, stabilizing total revenue but reducing per-unit profit margins.
3. Future Price Projections (Next 5 Years)
| Year |
Expected Price Range (per dose) |
Notes |
| 2023 |
$3,200–$4,000 |
Post biosimilar entry |
| 2025 |
$2,800–$3,800 |
Continued biosimilar penetration |
| 2027 |
$2,500–$3,500 |
Competitive pricing stabilizes |
Assumptions: Patent expirations, biosimilar market share growth, healthcare policy changes, and manufacturer pricing strategies.
Key Drivers and Risks
- Pricing Pressure: Increased biosimilar availability and payer negotiations reduce revenue.
- Regulatory Environment: Favorable policies accelerate biosimilar adoption but could introduce pricing controls.
- Market Penetration: Physician and patient acceptance of biosimilars remains critical.
- Manufacturing Costs: Significant improvements could influence pricing strategies.
Summary
The market price of NDC 00641-6061 (Rituximab) has declined substantially since biosimilar entry, with prices expected to stabilize at lower levels over the next five years. Revenue will likely shift from high-margin sales of the original to volume-driven sales of biosimilars, emphasizing the importance of market penetration and payer negotiations.
Key Takeaways
- Biosimilars have reduced Rituximab prices by approximately 20-40% post-2018.
- Wholesale acquisition costs currently range from $3,200 to $4,000 per dose, depending on the product.
- Market share for biosimilars is projected to surpass 60% within five years.
- Revenue projections reflect price erosion, balancing volume gains against lower per-unit margins.
- Patent expiration and regulatory policies significantly influence future pricing and market dynamics.
FAQs
1. What factors influence Rituximab pricing?
Market competition, biosimilar penetration, manufacturing costs, payer negotiations, and regulatory policies.
2. How do biosimilars impact the Rituximab market?
They reduce list prices, increase accessibility, and account for a growing share of total sales.
3. Are there upcoming patent expirations for Rituximab?
Yes. The primary patent expired in 2018, opening the market to biosimilars.
4. What is the outlook for Rituximab’s revenue?
Revenue is expected to decline in per-unit sales but may be maintained through volume increases driven by biosimilars.
5. How might healthcare policies affect future prices?
Policies promoting biosimilar use and price controls could accelerate price reductions.
References
- IQVIA, "Global Oncology Biosimilars Market Report," 2022.
- FDA, "Biosimilar Product Information," 2022.
- EvaluatePharma, "Rituximab Market Forecast," 2021.
- CMS, "Pricing Policies and Reimbursement," 2022.
- Company filings: Roche, Amgen, Pfizer annual reports (2018-2022).
