Last updated: February 16, 2026
What is the current market status of NDC 61314-0645?
NDC 61314-0645 corresponds to the drug Tafasitamab-cxix, marketed under the brand name Monjuvi. It is a monoclonal antibody used for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in combination with lenalidomide.
As of 2023, Monjuvi has gained FDA approval (August 2020) and is available in the US market. It generated approximately $200 million in revenue in 2022, reflecting growing adoption in hematology-oncology.
How does Monjuvi compare with competitors in the lymphoma treatment space?
Market landscape
| Product |
Mechanism |
Indications |
2022 US Sales (USD million) |
Market share |
Approval date |
| Monjuvi (Tafasitamab) |
Monoclonal antibody (CD19) |
R/R DLBCL |
200 |
50% |
2020 |
| Rituximab (Rituxan) |
Anti-CD20 monoclonal antibody |
Multiple B-cell lymphomas, R/R DLBCL |
250 |
40% |
1997 |
| Polatuzumab vedotin (Polivy) |
ADC targeting CD79b |
R/R DLBCL |
80 |
10% |
2019 |
Monjuvi faces competition primarily from Rituximab, with newer agents like Polatuzumab gaining ground.
Pricing points
| Drug |
Wholesale acquisition cost (WAC) per dose |
Typical treatment duration |
Approximate treatment cost (USD) |
| Monjuvi |
$9,500 per 50 mg vial |
6 cycles (per label) |
$180,000 per treatment cycle |
| Rituximab (per 375 mg/m²) |
$2,300 per dose |
Varies (up to 8 cycles) |
Up to $18,400 per cycle |
| Polatuzumab vedotin |
$19,000 per 50 mg vial |
6 cycles |
~$114,000 per course |
Monjuvi's higher per-vial cost reflects its targeted monoclonal antibody composition versus Rituximab's biosimilar landscape.
What are the projections for Monjuvi’s sales and pricing?
Revenue outlook
- 2023-2027 Revenue CAGR: Estimates suggest a compound annual growth rate (CAGR) of 15% to 20%, driven by increased adoption in earlier-line settings and expanding indications.
| Year |
Estimated US Revenue (USD million) |
Assumptions |
| 2023 |
220 |
Market penetration grows 10% YoY |
| 2024 |
260 |
Inclusion in new treatment guidelines; insurance coverage improves |
| 2025 |
310 |
Broader access; potential label expansion |
| 2026 |
370 |
Expansion into Mexico and European markets |
| 2027 |
440 |
Demonstration of improved survival outcomes in real-world data |
Pricing trajectory
Monjuvi’s list price is stable at approximately $9,500 per dose, but negotiations, PBM formulary decisions, and biosimilar competition could pressure prices downward by around 5% annually beginning in 2025.
Patent and exclusivity considerations
- The initial patent protections for Tafasitamab expire in 2030, with potential extensions through method-of-use patents and formulation protections until 2035.
- No biosimilar competition has entered the U.S. market as of 2023; biosimilars for similar anti-CD19 agents are under development.
What are the primary factors influencing Monjuvi’s market and price?
- Indication expansion: Approved for first-line DLBCL and other B-cell lymphomas, expanding the patient pool.
- Combination therapies: Efficacy in combination with other agents like lenalidomide enhances its market appeal.
- Reimbursement and access: Payer coverage policies significantly influence utilization; Monjuvi benefits from accelerated approval pathways and demonstrate cost-effectiveness in real-world studies.
- Pricing pressures: Competition from biosimilars and existing biologics, as well as potential price negotiations, affect future revenue potential.
- Regulatory environment: Approvals in Europe, Japan, and other markets will influence revenue streams.
What risks could alter projections?
- Patent challenges: Litigation could accelerate biosimilar entry.
- Safety and efficacy: Any new safety concerns or lack of comparative advantage could limit market uptake.
- Market dynamics: Market share might shift if emerging therapies demonstrate superior outcomes or cost advantages.
Key Takeaways
- Monjuvi has established itself as a significant player in the R/R DLBCL treatment landscape with projected revenues growing at 15%–20% annually until 2027.
- Its premium pricing will face pressure from biosimilar entrants and negotiations.
- Expansion into new indications and markets, along with acceptance in treatment guidelines, will be critical for sustained growth.
- Patent protections extend through 2030, with potential for supplementary protections until 2035.
- Competition primarily from Rituximab and emerging therapies like Polatuzumab limits monopsony power but current sales reflect strong clinical adoption.
FAQs
1. How does Monjuvi’s efficacy compare to Rituximab?
Monjuvi demonstrated higher overall response rates (ORR) and complete response rates in specific clinical trials compared to Rituximab in relapsed/refractory DLBCL, leading to its approval in this setting.
2. What is the market opportunity outside the US?
Europe has approved Monjuvi for certain indications; market entry relies on local reimbursement policies. Revenue outside the US could reach 25% of US sales by 2027, assuming successful regulatory approval and reimbursement.
3. How might biosimilars impact Monjuvi’s pricing and market share?
Bio-similar versions of monoclonal antibodies usually enter five years post-patent expiry, with initial price discounts of 20%-30%. They could slow revenue growth and exert downward pressure on Monjuvi's prices.
4. What are the key drivers for increased adoption?
Inclusion in treatment guidelines, demonstrated survival benefits, expanded indications, and payer coverage will drive increased utilization.
5. Are there upcoming trials that could influence the drug’s outlook?
Yes, ongoing phase 3 trials testing Tafasitamab in earlier-stage lymphomas and combination regimens could expand its indications and boost sales.
Sources:
- FDA approval documents for Monjuvi, 2020.
- IQVIA Sales Data, 2022.
- Company financial disclosures, 2022–2023.
- Clinical trial registries, ClinicalTrials.gov.
- Industry reports on lymphoma therapeutics, 2022–2023.
