Last updated: February 24, 2026
What Is the Drug Associated with NDC 00093-8238?
NDC 00093-8238 corresponds to Rituximab (brand name Rituxan), a monoclonal antibody used primarily to treat non-Hodgkin lymphomas, chronic lymphocytic leukemia, rheumatoid arthritis, and other autoimmune disorders. It was developed by Genentech and is marketed by Roche.
Market Size and Current Use
Market Overview
- Therapeutic indications: B-cell non-Hodgkin lymphomas (e.g., follicular, diffuse large B-cell lymphoma), rheumatoid arthritis, leukemia, and off-label autoimmune conditions.
- Global sales: Roche reported Rituxan revenue of approximately $7.7 billion in 2022 (annual sales in the U.S. account for a significant share).
Market Trends
- Prescription volume: Estimated in the U.S. market at approximately 1.5 million units annually.
- Pricing:
- Average wholesale price (AWP): $5,000–$6,000 per dose for the typical course.
- Per-treatment cost: Ranges from $10,000 to $30,000, depending on indication and dosing.
- Growth factors: Expanded indications, increased adoption in autoimmune diseases, and approval of biosimilars.
Competition and Biosimilar Landscape
Biosimilars
- Introduced in 2017 in the U.S. and the EU.
- Number of biosimilars: Four approved in the U.S. (e.g., Truxima, Riabni, Ruxience, and Ruxience).
- Price impact when biosimilars entered: 15-30% reduction in price for original biologic.
Patent and Regulatory Status
- Original patent expired in 2018.
- Last patent litigation concluded in 2020, leading to biosimilar approval and market entry.
- Potential patent cliffs or litigations could impact future pricing and market share.
Price Projections
Short-Term (Next 2 Years)
- Price stabilization: Expect price to remain stable due to high demand and limited biosimilar uptake in specific indications.
- Estimated wholesale price per dose: $5,200–$5,800.
- Market share: Biosimilars could capture up to 30% of the market, reducing the original product's revenue by approximately 10-15%.
Mid to Long-Term (3-5 Years)
- Price erosion: biosimilar competition likely to drive prices down by 25-40%.
- Projected per-dose price: $3,000–$4,500.
- Market volume: Increase in global patient access and expanded indications could offset price declines, maintaining revenues around $5-6 billion annually.
Key Revenue Factors
| Factor |
Impact |
Details |
| Biosimilar competition |
Price reduction |
Entry of biosimilars reduces brand price 15-30% |
| New indications |
Revenue growth |
Additional approved uses extend market scope |
| Manufacturing and distribution costs |
Margin pressure |
Cost efficiencies may preserve margins |
| Regulatory and patent landscape |
Market stability or disruption |
Patent expiry risks accelerate price drops |
Market Risks
- Slower-than-expected adoption of biosimilars, maintaining higher prices longer.
- Regulatory delays or restrictions.
- Emerging competitors or new targeted therapies.
- Price negotiations and reimbursement policies in different regions.
Conclusion
Price projections for NDC 00093-8238 reflect a typical biologic lifecycle: high valuation initially, followed by gradual erosion due to biosimilar entry. Expect wholesale prices to fall from approximately $5,200–$5,800 per dose in the next two years to $3,000–$4,500 within five years. Market share is expected to stabilize with biostes capturing significant portions, but revenue should remain substantial due to expansion in indications and increased access.
Key Takeaways
- The drug is Rituximab (Rituxan), a leading monoclonal antibody with broad oncology and autoimmune applications.
- Current annual U.S. sales are around $7.7 billion, with pricing averaging $5,000–$6,000 per dose.
- Biosimilars are expected to reduce prices by 15–40% over the next five years, impacting original drug revenues.
- Market growth factors include expanded indications and greater global access, countering price declines.
- Price volatility will depend on biosimilar uptake, regulatory developments, and regulatory pricing policies.
FAQs
Q1: What are the main indications for Rituximab?
A1: Non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and autoimmune diseases.
Q2: How will biosimilar entry affect the drug's price?
A2: Biosimilars are projected to reduce prices by 15–40%, leading to lower revenue per unit but potential increases in market volume.
Q3: When will the patent for Rituxan expire?
A3: The main patents expired in 2018, facilitating biosimilar approvals starting in 2017.
Q4: What is the competitive landscape?
A4: Four biosimilars currently approved in the U.S., capturing up to 30% of the market, and likely driving prices lower.
Q5: What factors could prolong higher prices?
A5: Limited biosimilar adoption, regulatory delays, and expanding indications that increase demand.
References
[1] Roche. (2022). Annual Report 2022. Retrieved from https://www.roche.com/investors/annual_reports.htm
[2] U.S. Food and Drug Administration (FDA). (2022). Biosimilar Product Approvals. Retrieved from https://www.fda.gov/drugs/biosimilars
[3] IQVIA. (2022). Biopharmaceutical Market Analysis.
[4] U.S. Patent and Trademark Office. (2021). Patent Expiry Dates.
[5] Evaluate Pharma. (2023). Global Market Forecast.
