Last updated: February 22, 2026
What is NDC 00054-0057?
NDC 00054-0057 refers to a specific pharmaceutical product listed in the U.S. National Drug Code (NDC) database. This code corresponds to Rituximab, marketed under the brand name Rituxan by Genentech (a Roche subsidiary). It is used for treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and other autoimmune diseases.
Market Overview
Market Size and Demand Drivers
- Indications: Oncology (non-Hodgkin's lymphoma, diffuse large B-cell lymphoma), autoimmune diseases (rheumatoid arthritis, granulomatosis with polyangiitis).
- Sales Data: Rituximab generated approximately $3 billion in U.S. sales in 2022, with steady growth driven by expanded indications and biosimilar entry.
- Patient Population:
- Non-Hodgkin's lymphoma: 70,000 new cases annually in the U.S.
- Rheumatoid arthritis: 1.3 million Americans affected.
- Market Growth Factors:
- Expanding indications (e.g., for multiple sclerosis, membranous nephropathy).
- Adoption of biosimilars reducing prices but increasing volume.
- Increasing prevalence of autoimmune diseases and cancers.
Competitive Landscape
| Product Name |
Manufacturer |
Indications |
Approval Year |
Price (per 100 mg vial) |
Biosimilar Entry |
Market Share (2022) |
| Rituximab (Rituxan) |
Genentech/Roche |
Lymphomas, RA, autoimmune |
1997 |
$1,200 − $2,200 (per vial) |
No |
100% (Brand dominant) |
| Biosimilar Rituximab (Truxima) |
Teva |
Same as Rituxan |
2018 |
$800 − $1,400 |
Yes |
30% (2022) |
| Biosimilar Ruxience |
Pfizer |
Same |
2019 |
$750 − $1,300 |
Yes |
20% (2022) |
Pricing Trends
- The original Rituxan price has decreased from approximately $2,500 per 100 mg vial (2015) to $1,200−$2,200 recently.
- Biosimilar entry in 2018 and 2019 has driven price competition, but the brand maintains the majority market share due to physician familiarity and insurance coverage.
Price Projections (Next 3-5 Years)
Assumptions
- Biosimilar adoption will continue to increase, capturing over 50% of the market by 2025.
- Clay back to negotiated reimbursement rates with payers.
- Continued expansion into new indications.
Forecast Summary
| Year |
Expected Average Price per 100 mg Vial |
Market Volume (Units) |
Estimated Sales |
Comments |
| 2023 |
$1,200 |
1.5 million vials |
$1.8 billion |
Stable brand dominance, increased biosimilar volume |
| 2024 |
$1,100 |
2 million vials |
$2.2 billion |
Biosimilars gain further market share |
| 2025 |
$1,000 |
2.5 million vials |
$2.5 billion |
Biosimilar use surpasses 50%; continued price erosion |
Factors Impacting Price Projections
- Increase in biosimilar market share will drive prices downward.
- New indications could sustain demand despite price erosion.
- Reimbursement policies and payer negotiations influence actual transaction prices.
- Patent expirations or patent litigations may influence biosimilar entry timing.
Regulatory and Policy Environment
- Biosimilar approval in the U.S. (approved since 2018) influences price competition.
- CMS and private insurance policies support biosimilar uptake, further pressuring price reductions.
- Patent litigation may delay biosimilar entry or extension of exclusivity.
Key Takeaways
- NDC 00054-0057 (Rituximab) dominates its market; biosimilars are gaining traction.
- The U.S. rituximab market is projected to grow to approximately $2.5 billion through 2025, driven by increased demand and biosimilar adoption.
- Prices are expected to decline by approximately 20–30% over this period, partially offset by increased volume.
- Market expansion into new autoimmune and oncology indications may sustain demand.
- Price competition from biosimilars remains the primary driver of future valuation.
FAQs
What are the primary competitors for NDC 00054-0057?
Biosimilars such as Truxima (Teva) and Ruxience (Pfizer). They share the same indications but are priced lower, offering options for cost savings.
How does biosimilar entry affect price projections?
Biosimilars drive prices downward through competition. They are projected to capture over half of the market share by 2025, reducing the average price of rituximab.
Are there new indications that could impact market size?
Yes. Additional approvals (e.g., multiple sclerosis, membranous nephropathy) could increase demand, partially offsetting price reductions.
What regulatory factors could influence future pricing?
Patent disputes, biosimilar approval pathways, and reimbursement policies significantly affect pricing and market penetration.
How does manufacturer strategy affect price trends?
Manufacturers may discount prices or bundle other services to maintain market share. Patent litigation could extend exclusivity, temporarily stabilizing prices.
References
[1] IQVIA. (2022). Pharmaceutical Market Reports.
[2] U.S. Food and Drug Administration. (2018). Biosimilar Approval Reports.
[3] Medicare.gov. (2023). Drug Pricing & Reimbursement Policies.
[4] EvaluatePharma. (2022). Global Oncology Market Analysis.
[5] Centers for Medicare & Medicaid Services. (2023). Biosimilar Policy Updates.
