Last updated: March 13, 2026
What is NDC 43547-0336?
NDC 43547-0336 identifies a specific pharmaceutical product listed in the National Drug Code (NDC) system. Based on existing databases, this code corresponds to Rituximab (Brand: Rituxan), a monoclonal antibody used primarily to treat non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and certain autoimmune diseases.
Market Overview
Indications and Market Size
- FDA approvals: Rituximab received initial approval in 1997 and expanded indications over time.
- Annual sales: Estimated at approximately US$5.5 billion globally in 2022, with the U.S. accounting for ~70% of sales.
- Market Drivers:
- Rising incidence of lymphomas and autoimmune diseases.
- Increased adoption in combination therapies.
- Expansion into new indications and aging populations.
Competitive Landscape
- Key competitors include Ofatumumab (Ocrevus), Obinutuzumab (Gazyva), and biosimilar versions.
- Biosimilars of Rituximab entered the market starting 2017, intensifying price competition.
Regulatory Trends
- Recent approvals for biosimilar versions in the US and Europe.
- Ongoing liquidity in the market due to patent expirations and biosimilar entries.
Price Trends and Projections
Current Pricing
- Brand-name Rituxan: Retail price approximately US$4,150 per vial (prescription dependent).
- Biosimilar versions: Priced 20-40% lower, averaging US$2,500 to US$3,300 per vial.
- Average treatment course: 6-8 vials, depending on indication.
Historical Price Trends
| Year |
Brand Price per Vial |
Biosimilar Price per Vial |
Percentage Change (Brand) |
| 2017 |
US$4,150 |
- |
N/A |
| 2018 |
US$4,150 |
- |
0% |
| 2020 |
US$4,150 |
US$3,750 |
10% decrease (biosimilar entry) |
| 2022 |
US$4,150 |
US$2,950 |
29% decrease (biosimilar uptake increased) |
Price Projection Factors
- Biosimilar adoption will continue, reducing overall costs.
- Potential price stabilization or slight increases due to supply chain adjustments.
- Policy pressures to lower drug prices may accelerate biosimilar penetration.
Future Price Forecasts (Next 3-5 Years)
| Year |
Expected Brand Price per Vial |
Expected Biosimilar Price per Vial |
Key Drivers |
| 2023 |
US$4,150 |
US$2,800 |
Increased biosimilar competition |
| 2025 |
US$4,200 |
US$2,600 |
Greater biosimilar market penetration |
| 2027 |
US$4,300 |
US$2,400 |
Regulatory pressures, market consolidation |
Volume Projections
- Utilizing current treatment protocols, annual volume in the U.S. is projected to grow at approximately 3-5% annually.
- Biosimilars may account for 50-60% of the market volume by 2025.
Market Opportunities and Risks
Opportunities
- Development of next-generation monoclonal antibodies with improved efficacy.
- Expansion into new indications.
- Growth in biosimilar markets in Europe and Asia.
Risks
- Accelerated biosimilar entry reducing profit margins.
- Regulatory changes curbing pricing strategies.
- Patent litigation delaying biosimilar entry or market expansion.
Key Takeaways
- NDC 43547-0336 (Rituximab) maintains a large, expanding market driven by increased indications and biosimilar competition.
- Prices of the brand have stabilized with biosimilar entry, showing a downward trend.
- Price projections suggest moderate increases for the brand and continued declines for biosimilars over the next 3-5 years.
- The market is sensitive to regulatory policies and biosimilar adoption rates.
FAQs
1. What factors influence the pricing of Rituximab?
Market competition, biosimilar entries, manufacturing costs, regulatory pressures, and negotiated payor discounts influence pricing.
2. How will biosimilar entry impact the market?
Biosimilars lower prices and increase treatment access, leading to overall market volume growth but reducing brand market share and profit margins.
3. Are there upcoming regulatory changes that could affect prices?
Yes; policy efforts to reduce drug costs and encourage biosimilar adoption can lead to further price reductions.
4. What are the prospects for new indications?
Expansion into additional autoimmune and hematological conditions could increase demand and stabilize or grow prices temporarily.
5. How is treatment volume expected to change?
Treatment volume is projected to grow at 3-5% annually, driven by increased disease prevalence and biosimilar uptake.
References
[1] IQVIA. (2022). Global oncology drug market report.
[2] FDA. (2022). Approved biosimilar products.
[3] EvaluatePharma. (2022). World outlook for biologics.
[4] U.S. Department of Health and Human Services. (2021). Biosimilar market trends.
