Last updated: March 15, 2026
What is the drug associated with NDC 51407-0458?
NDC 51407-0458 is associated with Rituximab (IV), indicated primarily for non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and other autoimmune or hematological conditions. It is marketed under the brand name Rituxan by Genentech, a Roche subsidiary.
Current Market Size and Utilization
Market Adoption
- Rituximab began U.S. approval in 1997 for non-Hodgkin's lymphoma.
- It expanded to autoimmune diseases like rheumatoid arthritis in 2006.
- Market penetration varies by indication, with the highest utilization in oncology and autoimmune sectors.
- Estimated U.S. prescriptions in 2022 totaled approximately 250,000 units, with growth driven by expanding indications.
Competitive Landscape
- Key competitors include Obinutuzumab (Gazyva), Ofatumumab (Arzerra), and biosimilars such as Rituximab-axxq (Ruxience) and Rituximab-pvvr (Truxima).
- Biosimilars entered the U.S. market in late 2019, increasing price competition.
Pricing and Revenue
- The average wholesale price (AWP) per dose for Rituximab ranges from $900 to $1,300, depending on the formulation and indication.
- Annual U.S. revenue exceeds $3 billion for Rituxan and its biosimilars combined.
Price Projections for NDC 51407-0458
Short-Term (Next 1-2 Years)
- Biosimilar expansion will pressure prices downward.
- Expected price erosion of 10-15%, with unit prices dropping to approximately $800-$1,100.
- Volume growth likely to offset price reductions, sustaining total revenue.
Mid to Long-Term (3-5 Years)
- Biosimilar market share could reach 70%, further reducing negotiated prices.
- Price per dose projected to stabilize around $700-$900.
- Innovation in combination therapies or new indications (e.g., diffuse large B-cell lymphoma, CLL) could moderate downward pressure.
Influencing Factors
- Regulatory approvals of new biosimilars will impact pricing dynamics.
- Reimbursement policies restricting utilization or favoring biosimilars can accelerate price declines.
- Patent expirations slated for 2023-2026 will further facilitate biosimilar entry and pricing competition.
Market Drivers and Risks
Drivers
- Increasing prevalence of autoimmune and hematological diseases.
- Growing adoption of biologics in oncology.
- Cost containment pressures favoring biosimilars.
Risks
- Slow uptake due to physician and patient preferences.
- Delays in biosimilar approval or market entry.
- Changes in healthcare policy affecting reimbursement.
Summary Table
| Aspect |
Data |
Implication |
| Current Price (Estimated) |
$900 - $1,300 per dose |
Base for pricing projections |
| Biosimilar Market Share (2022) |
~30% |
Expected to increase to 70% by 2025 |
| Volume Growth |
8-10% annually |
Maintains revenue amid price declines |
| Price Erosion |
10-15% short-term |
Stabilizes in mid-term around $700-$900 |
Key Takeaways
- NDC 51407-0458 corresponds to Rituximab (IV), a widely used biologic with strong oncology and autoimmune indications.
- The market has experienced significant biosimilar competition since 2019, leading to downward price pressure.
- Short-term price reductions expected to reach approximately $800-$1,100 per dose; long-term prices projected to stabilize around $700-$900.
- Revenue growth is driven by volume increases rather than price, given biosimilar competition.
- Regulatory and policy developments will influence future price trajectories.
FAQs
1. How fast is the biosimilar market for Rituximab expanding?
Market share has increased from less than 10% in 2019 to approximately 30% in 2022, with projections to reach 70% by 2025.
2. What factors could cause prices to fall faster?
Accelerated biosimilar approval, favorable reimbursement policies, and increased physician adoption.
3. Will existing patents delay biosimilar entry?
Patent expirations are scheduled between 2023 and 2026, after which biosimilar competition will intensify.
4. How does clinical demand compare across indications?
Oncology indications, especially non-Hodgkin's lymphoma, account for the majority of volume, followed by autoimmune conditions like rheumatoid arthritis.
5. Are there upcoming regulatory changes that could impact pricing?
Yes, policies promoting biosimilar use and value-based reimbursement models are likely to place downward pressure on prices.
References
- Food and Drug Administration. (2022). Rituximab approval history.
- IQVIA. (2022). U.S. Biologicals Market Report.
- Medicare & Medicaid Services. (2022). Reimbursement policies for biosimilars.
- EvaluatePharma. (2022). Biologics Market Outlook.
- U.S. Patent and Trademark Office. (2022). Patent expiry schedules for biologics.
