Last updated: February 22, 2026
What is the drug associated with NDC 82009-0034?
The National Drug Code (NDC) 82009-0034 identifies Tafasitamab-cxix (brand name Monjuvi). It is an anti-CD19 monoclonal antibody approved by the FDA in 2020. Monjuvi is indicated for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), used in combination with lenalidomide for patients who are ineligible for high-dose chemotherapy and stem cell transplant.
Market Overview
Sales and Market Penetration
Monjuvi’s sales reflect its niche position within the B-cell lymphoma treatment space. In 2022, global sales totaled approximately $150 million, with U.S. sales accounting for at least $120 million. Market penetration remains limited due to:
- Orphan drug status: Approved for specific relapsed/refractory DLBCL patients.
- Competition: Other CD19-targeted therapies, including CAR T-cell therapies like Axicabtagene ciloleucel and Lisocabtagene maraleucel.
- Physician familiarity: Limited awareness compared to established treatments.
Market Dynamics
- Growth Drivers:
- Rising incidence of DLBCL, estimated at 22,000 new cases annually in the U.S.
- Increasing preference for targeted immunotherapies over conventional chemotherapy.
- Expansion of indications and combination therapies.
- Constraints:
- High treatment costs, with list prices around $18,000 per infusion.
- Reimbursement complexities due to infusion requirements and administration costs.
- Competition from alternative therapies and emerging pipeline drugs.
Price Analysis
Current Pricing
- List price per dose: Approximately $18,000.
- Dosing schedule: Typically 1.5 mg/kg intravenously weekly for 3 weeks, then every 3 weeks.
- Average patient course: 6-8 doses, totaling approximately $108,000–$144,000 per treatment course.
Revised Pricing Trends
- Discounts offered through payers or negotiated healthcare contracts range between 10-20%.
- Market entry of biosimilars: None currently available; biosimilar entrants expected in the next 3-5 years may exert downward pressure.
Pricing Strategy Considerations
- Price adjustments driven by competitive landscape and reimbursement policies.
- Value-based pricing may become more prominent, linking costs to outcomes.
- Expansion into earlier lines of therapy could increase sales volume and influence pricing strategies.
Future Price Projections
Short-term (Next 2 Years)
- Stabilization of list prices at approximately $18,000 per dose.
- Possible discounts of 10%, leading to effective prices around $16,200 per dose.
- Annual revenue estimates range between $130 million and $180 million, assuming steady market uptake.
Mid to Long-term (3–5 Years)
- Introduction of biosimilars could reduce prices by 30-50%, bringing list prices down to $9,000–$12,000 per dose.
- Market expansion to earlier lines of therapy might increase volume, offsetting lower prices.
- Potential for price erosion influenced by payor negotiations and competition.
Competitive Landscape
| Drug Name |
Indication |
Approval Year |
Price Range |
Market Share (est.) |
| Monjuvi (NDC 82009-0034) |
R/R DLBCL |
2020 |
~$18,000/dose |
80% (current niche) |
| Axicabtagene ciloleucel |
CAR-T |
2017 |
$373,000 per treatment |
15% (overall lymphoma market) |
| Lisocabtagene maraleucel |
CAR-T |
2021 |
$475,000 per treatment |
5% (niche) |
Key Policies Affecting Pricing
- CMS reimbursement policies: Reimbursement based on hospital outpatient prospective payment system (OPPS) and cancer drug administration policies.
- Orphan Drug Act: Provides incentives but limited direct impact on pricing.
- Value-based agreements: Increasingly implemented to address high costs versus clinical benefits.
Conclusion
Monjuvi (NDC 82009-0034) maintains a high price point due to its targeted indication and limited competition. Market growth depends on expanding indications and biosimilar competition, which are likely to reduce prices over time. Short-term prices are expected to stabilize around current levels, whereas mid-term projections suggest significant discounts due to biosimilar entries.
Key Takeaways
- Monjuvi's sales remain concentrated in relapsed/refractory DLBCL patients; growth prospects hinge on indication expansion.
- The current price is approximately $18,000 per dose, with total treatment costs around $110,000–$145,000.
- Market entry of biosimilars could lower prices by up to 50% within 5 years.
- Revenue growth depends on increasing treatment volume and payer reimbursement policies.
- Competition from CAR-T therapies and pipeline drugs limits pricing power for Monjuvi.
FAQs
1. How does the price of Monjuvi compare to other targeted lymphoma therapies? The price is similar or slightly lower compared to CAR-T cell therapies, which often cost over $300,000 per treatment.
2. What factors could impact Monjuvi’s future pricing? Biosimilar competition, regulatory changes, reimbursement reforms, and expanded indications are primary influencers.
3. Are there any planned biosimilar entrants for Monjuvi? No biosimilars are currently approved; biosimilar competition is anticipated within 3-5 years.
4. How does payer coverage influence the drug’s price? Reimbursement negotiations can lead to discounts from list prices, affecting net revenue.
5. What is the market outlook for monoclonal antibody therapies in lymphoma? Continued growth driven by targeted therapies and combination treatments, but prices will face pressures from biosimilars and competitive alternatives.
References
- U.S. Food and Drug Administration. (2020). Monjuvi (Tafasitamab-cxix) labeling. https://www.fda.gov
- IQVIA. (2022). Oncology drug sales and market insights.
- CMS. (2022). Hospital Outpatient Prospective Payment System (OPPS). https://www.cms.gov
- EvaluatePharma. (2022). Oncology market forecasts.
- Biosimilar Development. (2023). Biosimilar entrants and pricing strategies.
