Last updated: March 18, 2026
What is NDC 00131-2480?
NDC 00131-2480 identifies a specific drug product listed within the National Drug Code Directory, indicating a formulation, strength, and packaging detail. Based on available data, this NDC corresponds to Rituximab, a monoclonal antibody used primarily for various hematologic and autoimmune conditions, including non-Hodgkin's lymphoma, rheumatoid arthritis, and chronic lymphocytic leukemia.
Market Overview
Current Market Size
The global Rituximab market was valued at approximately $7.8 billion in 2022 [1]. The U.S. accounts for roughly 40% of this total. The growth rate, compounded annually, is expected at 6% over the next five years, driven by expanding indications and increased adoption in autoimmune diseases [2].
Competitive Landscape
Major competitors include:
- Roche's Rituxan (original biologic)
- Celltrion's Truxima (biosimilar)
- MediUS's Ruxience (biosimilar)
- Sandoz's Rixathon (biosimilar)
Biosimilars launched from 2019 onward have significantly eroded the pricing power of the originator. U.S. biosimilar penetration reached 25% in 2022, leading to price reductions for the reference product [3].
Regulatory Status
The original Rituximab (Rituxan) received FDA approval in November 1997. Multiple biosimilars, including Ruxience (approved July 2019), have been on the market since 2020, increasing supply and reducing prices.
Market Drivers
- Expanded indications, particularly in autoimmune diseases
- Growing prevalence of rheumatoid arthritis and non-Hodgkin's lymphoma
- Patent expiration of the originator biologic
Market Challenges
- Entry of biosimilars leading to price erosion
- Reimbursement pressures
- Manufacturing and supply chain complexities
Price Analysis
Historical Pricing Trends
Prices for Rituximab have declined since biosimilar launches. The average wholesale price (AWP) for the original biologic was approximately $5,000 per 100-mg vial in 2018. Biosimilar versions have retailed at about 30-50% lower than the originator.
Current Pricing Data
| Product |
Price per 100-mg vial |
Year |
Notes |
| Rituxan (Originator) |
$4,950 |
2022 |
Price after biosimilar market entry |
| Ruxience (Biosimilar) |
$2,700 |
2022 |
Approximate average negotiated price |
| Truxima (Biosimilar) |
$2,650 |
2022 |
Similar market price |
Projected Price Trajectory
Prices are expected to decline by an additional 10-20% over the next five years due to increased biosimilar competition and payer negotiations [4].
| Year |
Expected Price Range per 100-mg vial |
Change from 2022 |
Notes |
| 2023 |
$2,400 - $2,600 |
-10% to 0% |
Market stabilization in biosimilar pricing |
| 2025 |
$2,000 - $2,300 |
-20% to -15% |
Greater market penetration and price competition |
| 2027 |
$1,800 - $2,100 |
-30% to -20% |
Increased biosimilar competition, payer discounts |
Pricing Impact Factors
- Market penetration of biosimilars
- Reimbursement policies
- Supply chain adjustments
- Patent litigation outcomes
Revenue Projections
Assuming a typical treatment regimen involves 375 mg/m2 weekly for 4 weeks, then maintenance dosing, the average annual treatment dose per patient is estimated at approximately 1,200 mg, roughly 12 vials at current prices.
Revenue Estimates for a Representative Market Share
| Year |
Patients (000s) |
Revenue (USD millions) |
Key Assumptions |
| 2022 |
50 |
$80 |
Current market size with biosimilar uptake |
| 2025 |
65 |
$104 |
Growth driven by rising autoimmune disease prevalence |
| 2027 |
80 |
$128 |
Further biosimilar adoption and expanded indications |
Key Market Factors
- Regulatory changes: Faster approvals for biosimilars can accelerate price erosion.
- Patent expiries: These influence the timing and extent of biosimilar entry.
- Market penetration: The rate at which biosimilars replace the originator affects revenue streams and pricing.
Summary
The drug identified as NDC 00131-2480 (Rituximab) faces a mature yet evolving market landscape characterized by significant biosimilar competition. Prices have declined noticeably since biosimilar approvals, with further declines anticipated. Revenue growth depends heavily on biosimilar adoption and expanding indications.
Key Takeaways
- The original Rituximab (Rituxan) has a decreasing market share due to biosimilar competition.
- Prices are projected to fall 20-30% over the next five years.
- Market size continues to grow, driven by autoimmune and hematologic indications.
- Reimbursement and patent policies influence pricing and market penetration.
- Future revenue depends on biosimilar adoption rates and regulatory developments.
FAQs
1. How have biosimilars affected Rituximab pricing?
Biosimilars launched from 2019 onwards reduced the average price by approximately 50%, with further decreases expected as market share expands.
2. What are the key factors influencing Rituximab market growth?
Indications expansion, growing prevalence of autoimmune diseases, and biosimilar entry are core growth drivers.
3. What is the typical price range for biosimilar Rituximab?
Current prices range from $2,650 to $2,700 per 100-mg vial, approximately a 45-50% discount from originator prices.
4. How might regulatory changes impact future pricing?
Accelerated approval pathways for biosimilars and patent litigation outcomes can either expedite market competition or delay biosimilar entry, influencing prices.
5. What is the outlook for Rituximab's revenue in the next five years?
Revenue is projected to decline due to falling prices but may grow overall due to increasing patient volumes and expanded indications.
References
[1] MarketWatch. (2023). Rituximab market size and forecasts. Retrieved from https://www.marketwatch.com
[2] Grand View Research. (2022). Monoclonal antibodies market analysis. Grandviewresearch.com
[3] IQVIA. (2022). Biosimilar utilization report. IQVIA.com
[4] EvaluatePharma. (2022). Pharmaceutical industry price trend report. Evaluate.com
