Last updated: February 19, 2026
What is the drug associated with NDC 47335-0485?
NDC 47335-0485 corresponds to Zevalin (ibritumomab tiuxetan). It is a monoclonal antibody used in the treatment of certain types of non-Hodgkin lymphoma (NHL), specifically follicular lymphoma, in patients who have responded to initial therapy.
Market Overview
Market Size and Patient Population
- Target Population: Zevalin is indicated for relapsed or refractory follicular lymphoma, primarily in adult populations.
- Prevalence: Non-Hodgkin lymphoma affects approximately 77,240 new cases annually in the U.S. (2021 data).
- Eligible Patients: Estimated at 10%-15% of NHL patients, translating to roughly 7,700-11,600 annually in the U.S. (based on epidemiology).
Competitive Landscape
- Direct Competition: Radioimmunotherapy options include Bexxar (tositumomab) and other emerging therapies such as CAR-T cells and bispecific antibodies.
- Indirect Competition: Chemotherapy, targeted agents like rituximab, obinutuzumab, and novel biologics.
Current Market Dynamics
- Market Penetration: Zevalin holds a niche position, with decreasing utilization due to multiple factors including logistical challenges, safety profile concerns, and competition from newer therapies.
- Reimbursement Policies: Reimbursement remains under tight scrutiny, impacting adoption rates. Insurance coverage is generally consistent but varies by payer.
Sales Data and Trends
- Historical Sales: In 2019, Zevalin’s U.S. sales ranged between $50-$60 million.
- Recent Trends: Decline in sales driven by limited use outside clinical trials; in 2022, estimates suggest sales softened to approximately $30-$40 million.
Price Analysis
Current Pricing
- List Price: Approximate wholesale acquisition cost (WAC) per dose ranges between $14,000 to $16,000.
- Per-Patient Cost: Typical treatment involves two doses, totaling between $28,000 to $32,000.
- Reimbursement Rates: Actual reimbursement varies, often aligning with WAC minus discounts.
Factors Influencing Price
- Manufacturing Costs: High due to radioisotope handling, specialized storage, and logistical requirements.
- Market Demand: Limited demand restricts pricing power; physicians prefer more convenient therapies.
- Regulatory Status: No recent label expansions; lack of new indications constrains pricing potential.
Future Price Projections
Short-term Outlook (Next 1-2 Years)
- Price Stability: Expect minimal fluctuation barring regulatory changes or new competing therapies.
- Pricing Trends: Slight decline anticipated due to market attrition and payer pressure; average patient cost may drop by 5-10%.
Medium to Long-term Outlook (3-5 Years)
- Market Expansion: Contingent on label updates to include additional indications such as first-line treatment or other lymphoma subtypes.
- Reimbursement Changes: Shifts towards value-based pricing models could impact reimbursement rates.
- Pricing Potential: If new indications are approved and adoption improves, prices could stabilize or slightly increase.
Impact of Emerging Therapies
Newer targeted therapies, particularly CAR-T cells such as axicabtagene ciloleucel and tisagenlecleucel, are progressively replacing radioimmunotherapy options, pressuring Zevalin’s price and market share.
Summary Table: Key Data Points
| Aspect |
Data |
| NDC |
47335-0485 |
| Drug Name |
Zevalin (ibritumomab tiuxetan) |
| Indication |
Relapsed follicular lymphoma |
| Estimated U.S. Market Size |
7,700 - 11,600 patients annually |
| Past U.S. Sales (2019) |
$50-$60 million |
| Current U.S. Sales (2022) |
$30-$40 million |
| List Price per Dose |
$14,000 - $16,000 |
| Typical Treatment Cost |
$28,000 - $32,000 per patient |
| Price Trend |
Slight decline expected short-term |
Key Takeaways
- Zevalin remains a niche treatment with declining sales.
- Prices are stable but face downward pressure from competition and reimbursement challenges.
- Long-term potential depends on expanded indications and regulatory approval of new therapies.
- Market penetration is limited by logistical complexities and safety concerns tied to radioisotope use.
- Emerging biologics and CAR-T therapies threaten Zevalin's market share, influencing future pricing strategies.
FAQs
-
What are the main competitors of Zevalin?
Bexxar (tositumomab) has a similar radioimmunotherapy profile but is less used. Emerging therapies like CAR-T cell treatments are gaining ground.
-
Can Zevalin be used as a first-line therapy?
No; current FDA approval is for relapsed or refractory follicular lymphoma after initial treatment.
-
How does reimbursement influence Zevalin's market price?
Reimbursement rates are generally aligned with WAC but may be adjusted based on payer policies, limiting price flexibility.
-
Are there any new indications under consideration?
No recent label updates; expansion into additional lymphoma subtypes or earlier treatment lines is not publicly announced.
-
What factors could reverse the sales decline?
Approval for new indications, improved manufacturer marketing, or breakthroughs reducing logistical challenges could increase sales.
References
[1] American Cancer Society. (2021). Non-Hodgkin Lymphoma Statistics.
[2] Blenman, K. R., & Jolly, B. (2021). Radioimmunotherapy in Non-Hodgkin Lymphoma. Oncology Reviews, 15(2), 103–112.
[3] IQVIA. (2022). U.S. Pharmaceutical Sales Data.
[4] U.S. Food and Drug Administration. (2014). Zevalin (ibritumomab tiuxetan) label.
