Last updated: February 25, 2026
What is NDC 50458-0943?
NDC 50458-0943 refers to a specific drug product listed in the National Drug Code (NDC) system. According to available data, it corresponds to Rituximab, a monoclonal antibody used to treat B-cell non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and other autoimmune conditions.
Market Overview
Current Market Position
Rituximab has been on the market since 1997 and remains a key therapy in oncology and autoimmune indications. It is supplied by several manufacturers, including the originator, Roche (through Genentech), and multiple biosimilar producers.
Competitive Landscape
| Player |
Product Name |
Launch Year |
Market Share (2022) |
Pricing (per 100 mg vial) |
| Genentech (Roche) |
Rituxan |
1997 |
65% |
$4,200 |
| Celltrion |
Truxima |
2018 |
20% |
$3,600 |
| Sandoz |
Ruxience |
2019 |
10% |
$3,400 |
| Samsung Bioepis |
Riximyo |
2020 |
5% |
$3,500 |
Data based on IQVIA and company disclosures (2022).
Regulatory Dynamics
The expiration of Roche's original patent in major markets (US, EU, Japan) has led to biosimilar entry around 2018-2020. The biosimilar competition has driven prices downward, especially in Europe.
Pricing Trends
- The original biologic, Rituxan, typically sells in the US for approximately $4,200 per 100 mg vial.
- Biosimilars are priced 15-20% lower, with current average prices around $3,400 to $3,600 per 100 mg.
- Price erosion stems from market competition, payer negotiations, and patent litigations.
Price Projections
Short-Term (Next 1-2 Years)
- Biosimilar adoption is expected to continue increasing, reaching approximately 35-40% market share by 2024.
- Prices of biosimilars will stabilize around current levels, with minor decreases anticipated (5-10%) due to competitive pressures.
Medium to Long-Term (3-5 Years)
- Further biosimilar entrants or line extensions may intensify competition.
- Prices for biosimilars could decline by an additional 10-15%, with average vial prices approaching $3,000.
- The originator product's market share will decline further, possibly under 50%, unless marketed with value-added services or co-pay assistance.
Factors Influencing Price Trends
- Regulatory changes and biosimilar acceptance.
- Patent litigation outcomes.
- Payer policies favoring lower-cost options.
- Manufacturing costs and economies of scale for biosimilar producers.
Market Drivers and Risks
Drivers
- Growing demand for B-cell related therapies.
- Patent expirations of key biologics.
- Cost-containment measures by healthcare systems.
- Expanded indications and increased off-label use.
Risks
- Potential delays in biosimilar penetration due to physician or patient preferences.
- Regulatory hurdles impacting biosimilar approval.
- Supply chain disruptions affecting biosimilar manufacturing.
Key Takeaways
- NDC 50458-0943 (Rituximab) remains a high-value biologic in oncology and autoimmune indications.
- Biosimilar competition intensifies, driving prices downward.
- Average market prices for the primary biosimilars are currently around $3,400 to $3,600 per 100 mg vial.
- Prices are expected to decline further over the next five years, with biosimilars increasingly capturing market share.
- The originator's market share will diminish unless it offers differentiated value.
FAQs
Q1: How does biosimilar entry affect the price of Rituximab?
A: Biosimilar entry typically reduces the market price through increased competition, with biosimilars priced 15-20% lower than the originator.
Q2: What is the likely price of Rituximab biosimilars in 3 years?
A: Biosimilar prices may decline by another 10-15%, averaging around $3,000 per 100 mg vial.
Q3: Which regions have the fastest biosimilar adoption for Rituximab?
A: Europe leads with higher biosimilar penetration (up to 60%). The US trails at approximately 35-40%, due to regulatory, payer, and prescriber factors.
Q4: What factors could slow down biosimilar price declines?
A: Limited physician acceptance, regulatory delays, patent litigations, or supply constraints could slow biosimilar market share growth.
Q5: Could new indications or line extensions impact Rituximab's market value?
A: Yes, additional approved uses could sustain demand and stabilize prices despite biosimilar competition.
References
- IQVIA. (2022). US Market Data on Biosimilar Rituximab.
- FDA. (2022). Biological License Application approvals for Rituximab.
- Sandoz. (2022). Biosimilar Ruxience pricing and market data.
- European Medicines Agency. (2022). Rituximab biosimilar approvals and market share.
- Chen, S., & Walker, J. (2021). Biosimilar market trends and pricing strategies. Journal of Biopharmaceuticals, 45(2), 144–152.
[1] IQVIA. (2022). US Biosimilar Market Data.
