Last updated: February 15, 2026
What is NDC 50458-0140?
The NDC (National Drug Code) 50458-0140 refers to Zevalin (ibritumomab tiuxetan), a radioimmunotherapy product marketed by Spectrum Pharmaceuticals and affiliated companies. Zevalin is indicated primarily for the treatment of certain types of non-Hodgkin's lymphoma (NHL).
Market Size and Players
Current Market Context:
- Indications: Uses include third-line treatment for follicular lymphoma and relapsed/refractory low-grade or transformed NHL.
- Manufacturers: Spectrum Pharmaceuticals owns rights, with Teva Pharmaceuticals distributing in some regions.
Market Size Estimates (2022-2023):
| Parameter |
Data |
| Estimated U.S. annual sales |
$150 million - $200 million |
| Number of units shipped annually |
Approx. 3,000 - 4,000 treatments |
| Pricing per treatment (list price) |
$60,000 - $85,000 |
| Average treatment cycle |
1 dose (single infusion) or two-dose regimen considering patient specifics |
Market Dynamics:
- Use constrained by approval indications, primarily in specific lymphoma subtypes.
- New therapies in lymphoma may impact market share.
- Clinical data advancements or label expansions could influence usage.
Price Projections (2023–2028)
Price trajectories for Zevalin hinge on regulatory, competitive, and manufacturing factors.
| Year |
Estimated Price per Treatment |
Comments |
| 2023 |
$75,000 - $85,000 |
Current list prices, with variability based on package, payer negotiations |
| 2024 |
$72,000 - $83,000 |
Slight decline due to payer pressure, biosimilar considerations |
| 2025 |
$70,000 - $80,000 |
Expected stabilizations or slight decreases; impact of competition |
| 2026 |
$68,000 - $78,000 |
Possible collaboration with biosimilar entrants; price pressure |
| 2027 |
$65,000 - $75,000 |
Market maturation, insurance negotiations intensify |
| 2028 |
$63,000 - $72,000 |
Further downward trend anticipated with biosimilar or alternative therapies |
Market Drivers and Risks
Drivers:
- Growing prevalence of NHL
- Established efficacy and safety profile
- Potential expansion of indications or new combinations
- Reimbursement trends favoring targeted therapies
Risks:
- Introduction of biosimilars or novel therapies
- Regulatory restrictions or safety concerns
- Changes in treatment guidelines favoring other options
- Manufacturing complexities affecting supply and pricing
Competitive Landscape
| Competitors & Alternatives |
Notes |
| Rituximab (Rituxan) |
Widely used monoclonal antibody, often first-line |
| Tositumomab (Bexxar) |
Similar radioimmunotherapy, less favored now |
| Other targeted agents |
CAR-T therapies (e.g., axicabtagene ciloleucel) |
Market share is influenced by treatment guidelines, reimbursement access, and physician prescribing behavior.
Key Takeaways
- NDC 50458-0140 (Zevalin) operates in a niche lymphoma therapy market with steady demand.
- Prices range from approximately $63,000 to $85,000 per treatment cycle.
- Market projections show a slight decline in prices driven by biosimilar competition, insurance negotiations, and evolving treatment paradigms.
- The overall market remains constrained but stable with steady growth in lymphoma cases.
FAQs
Q1. What factors could significantly impact Zevalin’s price in the next five years?
The entry of biosimilars, changes in clinical guidelines, and shifts in reimbursement policies could pressure prices downward. Regulatory approvals for expanded indications may temporarily uplift prices.
Q2. How does Zevalin compare in price and efficacy to other lymphoma treatments?
It is priced higher than conventional monoclonal antibodies like rituximab but is more targeted, with efficacy demonstrated in specific indications. However, emerging therapies like CAR-T could alter its relative position.
Q3. Are there regional differences in the pricing of Zevalin?
Yes. U.S. prices are generally higher than in Europe or Asia due to different reimbursement systems and negotiation power. Actual treatment costs vary based on insurance coverage and institution agreements.
Q4. What are the key challenges for Zevalin's market growth?
Limited indications, competition from newer therapies, and potential biosimilar entry are primary challenges. Economic factors influencing healthcare spending also affect market expansion.
Q5. How might regulatory changes influence Zevalin’s market?
If authorities approve additional indications or streamline approval pathways, demand could increase. Conversely, safety concerns or regulatory restrictions could limit use.
References
- FDA label for Zevalin.
- Market research reports from EvaluatePharma and IQVIA.
- Public earnings reports from Spectrum Pharmaceuticals.
- Pricing and reimbursement data from CMS and drug pricing trackers.
- Clinical guidelines from NCCN and ESMO.
