Last updated: February 22, 2026
What is the Drug Associated with NDC 65219-0293?
NDC 65219-0293 corresponds to Tafasitamab (Monjuvi), a monoclonal antibody approved by the FDA in August 2020 for treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adult patients who are ineligible for autologous stem cell transplant. It is indicated for combination use with lenalidomide.
Market Overview
Market Size and Patient Population
- Estimated U.S. DLBCL incidence: ~24,000 cases annually (Lymphoma Research Foundation, 2022).
- Target patient subset: Relapsed/refractory DLBCL patients ineligible for stem cell transplant (~40%).
- Total eligible patients: approximately 9,600 annually.
Competitive Landscape
- Main competitors: Rituximab, polatuzumab vedotin, loncastuximab tesirine.
- Monjuvi's distinctiveness: First Fc-enhanced monoclonal antibody approved for this indication; further differentiated by mechanism and combination approvals.
Pricing and Revenue Estimations
Current Pricing
- List price (2019): approximately $11,110 per 50 mg vial.
- Dosing: 12 mg/kg every 3 weeks, average course duration: 6-8 cycles (~18-24 weeks).
- Estimated per-patient treatment cost: $150,000–$180,000.
Revenue Projections
| Year |
Estimated US Patients |
Market Penetration |
Revenue ($ millions) |
| 2023 |
2,000 |
20% |
200 |
| 2024 |
3,000 |
30% |
450 |
| 2025 |
3,600 |
40% |
720 |
Note: Assumes steady growth in prescriptions based on increasing adoption and expanding indications.
Pricing Trends and Future Projections
- Price sensitivity: Moderate; PBMs and payers seek value-based arrangements.
- Potential for price adjustments downward due to biosimilar competition in 5-7 years.
- Indexation: List prices tend to increase ~3-5% annually, aligning with inflation and manufacturing costs.
Factors Influencing Future Pricing
- Introduction of biosimilars: Limited currently; expected entry in 2028-2030.
- Expanded indications: Could justify price increases.
- Reimbursement policies: Shift towards value-based pricing may pressure prices.
Regulatory and Market Dynamics
- FDA approval for additional lines: Ongoing studies in follicular lymphoma and other B-cell malignancies.
- Pricing negotiations: CMS and commercial payers' negotiations impact net revenue.
- Patent landscape: Monjuvi’s patent protections extend into the next decade, influencing exclusivity and pricing strategies.
Summary
NDC 65219-0293 (Tafasitamab) is positioned as a specialized, high-cost biologic targeting a niche but sizable patient population. Its revenue potential depends on market penetration, pricing strategies, and biosimilar competition. Price projections suggest modest annual increases unless disrupted by biosimilars within five years.
Key Takeaways
- Monjuvi’s pricing remains high at approximately $11,110 per vial, leading to treatment costs upwards of $180,000 per patient.
- Market share growth is projected to accelerate as clinical adoption increases, reaching approximately 40% of eligible patients by 2025.
- Biosimilar entry is likely to begin in 2028, exerting downward pressure on list prices.
- Reimbursement and payer negotiation strategies could influence net revenue more than list price changes.
FAQs
1. What factors most influence the price of NDC 65219-0293?
Patient population size, clinical adoption rates, competition, and reimbursement policies.
2. When are biosimilars expected for Monjuvi?
Potential biosimilar entry is projected around 2028-2030.
3. How does Monjuvi compare with alternative treatments?
It offers a novel mechanism with favorable efficacy in refractory cases, but costs are higher than traditional chemoimmunotherapy.
4. What market segments are most promising for NDC 65219-0293?
Patients ineligible for stem cell transplantation and those with relapsed/refractory disease across the U.S.
5. How might policy changes affect future pricing?
Reimbursement reforms and increased use of value-based contracts could pressure prices downward.
References
- Lymphoma Research Foundation. (2022). Lymphoma facts & statistics.
- U.S. Food and Drug Administration. (2020). Monjuvi (Tafasitamab-cxix) prescribing information.
- IQVIA. (2023). Market Access Data and Pricing Trends.
- Centers for Medicare & Medicaid Services. (2022). Reimbursement and Policy Updates.
- Evaluate Pharma. (2023). Biologic Market Forecasts.
