Last updated: February 21, 2026
What is the drug with NDC 69292-0522?
The drug with NDC 69292-0522 is Tafasitamab (Monjuvi), a monoclonal antibody used for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL). It received approval from the U.S. Food and Drug Administration (FDA) in August 2020 under a Priority Review pathway. Monjuvi is administered in combination with lenalidomide.
Market Overview
Market Position
Tafasitamab, marketed as Monjuvi, entered a niche market focusing on relapsed or refractory DLBCL patients, a segment with high unmet medical needs. The drug competed directly with other therapies such as CAR T-cell treatments (Kymriah, Yescarta), which are more aggressive but prescribed in specific relapsed cases.
Disease Epidemiology
Annual incidence rates of DLBCL in the U.S.:
- Approx. 22,000 new cases annually (2021)
- Median age at diagnosis: 66 years
- Relapsed/refractory cases: 30-40%, constituting the primary target population for Monjuvi
Market Penetration and Adoption Factors
- Monjuvi's label indicates its use after at least two prior therapies.
- Cost considerations and reimbursement policies influence adoption.
- Competition from CAR T-cell therapies and other monoclonal antibodies impacts market share.
Regulatory and Reimbursement Landscape
- FDA approval in August 2020 positioned Monjuvi as an option for specific patient subsets.
- Commercial coverage varies, with high costs potentially limiting access.
- The drug's pricing strategy is critical to gaining market share.
Price Analysis
Current Pricing Overview
- Wholesale Acquisition Cost (WAC): Approximately $13,950 per 50 mg vial (as of 2023, based on publicly available pricing data[1]).
- Dose calculation assumes 12 mg/kg administered intravenously on Days 1 and 2 of each 21-day cycle, up to 6 cycles, depending on patient weight.
Cost Breakdown
| Parameter |
Details |
| Price per vial |
$13,950 for 50 mg |
| Typical dosing |
12 mg/kg per dose, 2 doses per cycle |
| Patient weight |
Average 70 kg |
| Number of vials per cycle |
Approx. 2-3 vials (based on dose calculation) |
| Total treatment cost |
Estimated $84,000 - $126,000 per treatment course |
Price Comparisons
| Drug |
Approved Use |
Approximate WAC |
Market Position |
| Monjuvi (Tafasitamab) |
R/R DLBCL, combination with lenalidomide |
$13,950 per vial |
Targeted immunotherapy in niche segment |
| Kymriah (Tisagenlecleucel) |
CAR T-cell, certain lymphomas |
~$475,000 per treatment |
First-line in relapsed settings, highly costly |
| Yescarta (Axicabtagene ciloleucel) |
Similar to Kymriah |
~$373,000 per treatment |
Compact use in relapsed lymphoma |
Market Projections (2023-2028)
Revenue Estimates
Assuming steady adoption with a gradual increase in market share, consider:
- 2023: 1,200 treatments in the U.S.
- Compound annual growth rate (CAGR): 10% (reflecting expanded label use and increased acceptance)
| Year |
Estimated Treatments |
Revenue (millions USD) |
| 2023 |
1,200 |
$16.1 |
| 2024 |
1,320 |
$17.7 |
| 2025 |
1,452 |
$19.4 |
| 2026 |
1,597 |
$21.3 |
| 2027 |
1,757 |
$23.4 |
| 2028 |
1,932 |
$25.8 |
Market Drivers
- Expanding use in earlier lines if approved.
- Potential label extension for other B-cell lymphomas.
- Government reimbursement policies and payer acceptance.
Market Risks
- Entry of biosimilars or generics after patent expiry.
- Competition from first-line therapies or newer immunotherapies.
- Cost containment policies impacting reimbursement.
Patent and Patent Expiry
Tafasitamab's primary patents expire in 2030-2035, with exclusivity period influencing pricing pressure and competitive entry. Patent challenges could alter projections if successful biosimilars surface.
Key Takeaways
- The current drug price for Monjuvi is approximately $13,950 per 50 mg vial.
- Estimated annual treatment revenues are projected to grow from about $16 million in 2023 to over $25 million by 2028.
- Market share growth depends on expanded indications, competitive landscape, and reimbursement policies.
- Key competitors include CAR T-cell therapies, which have significantly higher costs but broader indications and higher efficacy in some cases.
FAQs
Q1: What factors influence the price of Monjuvi?
Pricing depends on production costs, market demand, reimbursement negotiations, and competitive dynamics.
Q2: How does Monjuvi compare in cost to CAR T-cell therapies?
Monjuvi's treatment cost (~$84,000-$126,000) is significantly lower than CAR T therapies (~$375,000-$470,000), but CAR T therapies often have higher efficacy in some relapsed cases.
Q3: What is the potential for price reductions?
Generic or biosimilar entry post-2030 could lead to price reductions, especially in highly competitive markets.
Q4: How does approval expansion affect market projections?
Additional indications increase eligible patient population, driving revenue growth.
Q5: What are the main barriers to increasing Monjuvi's market share?
High treatment costs, competition from CAR T therapies, limited positioning post-approval, and reimbursement challenges.
References
[1] IQVIA. (2023). "U.S. Prescription Drug Price Database."
