Last updated: February 14, 2026
What is NDC 68462-0585?
NDC (National Drug Code) 68462-0585 is identified as Tafasitamab-cxix, marketed by MorphoSys and Incyte under the brand name Minjuvi. It is a CD19-targeted antibody used in the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), particularly as a monotherapy.
Market Landscape
Indication and Patient Population
Tafasitamab's primary indication targets relapsed/refractory DLBCL in adult patients who are ineligible for autologous stem cell transplant. The estimated annual US prevalence of DLBCL stands at approximately 25,000 cases, with about 60% requiring salvage therapy following initial treatment.
Key Competitors
- Breyanzi (lisocabtagene maraleucel): CAR T-cell therapy.
- Yescarta (axicabtagene ciloleucel): CAR T-cell therapy.
- Polivy (polatuzumab vedotin): Antibody-drug conjugate.
- Rituximab: Monoclonal antibody for earlier lines.
Tafasitamab's targeted niche positions it among second-line or salvage therapies, with endogenous competition from CAR T-cell therapies and antibody-based treatments.
Market Penetration
Since FDA approval in 2020, Minjuvi has gained a modest market share because of its recent entry and administration challenges (weekly infusions for 12 weeks). Commercial adoption depends on physician familiarity, reimbursement policies, and patient eligibility.
Pricing Overview
Current List Price
- US wholesale acquisition cost (WAC): Approximately $4,842 per 20 mg vial.
- Typical dose: 12 mg/kg IV once weekly for 3 weeks, then every 3 weeks, with an average patient dose around 400 mg per cycle.
- Estimated per-cycle cost: $20,000 to $27,000 depending on patient weight and vial usage.
Pricing Comparison
| Drug |
Type |
List Price (per vial or dose) |
Approved Indication |
Market Launch Year |
| Tafasitamab (Minjuvi) |
Monoclonal antibody |
~$4,842 per 20 mg vial |
R/R DLBCL |
2020 |
| Polatuzumab vedotin (Polivy) |
Antibody-drug conjugate |
~$5,032 per 100 mg vial |
R/R DLBCL |
2019 |
| Axicabtagene ciloleucel (Yescarta) |
CAR T therapy |
~$373,000 per dose |
R/R large B-cell lymphoma, post-chemo |
2017 |
| Lisocabtagene maraleucel (Breyanzi) |
CAR T therapy |
~$410,000 per dose |
Similar indications |
2021 |
Price Projection Factors
- Market adoption rate: Limited initial prescribing, but expected to increase with physician familiarity and improved logistics.
- Reimbursement landscape: Payer coverage influences access; negotiations may reduce effective prices.
- Competitive shifts: The rise of CAR T therapies could impact demand; pricing strategies must account for competitive pricing.
Forecasted Pricing Trends (2023–2028)
| Year |
Expected Average Price Per Treatment Cycle |
Key Drivers |
| 2023 |
$22,000 |
Market entry and initial adoption |
| 2024 |
$21,500 |
Price stabilization, payer negotiations |
| 2025 |
$20,500 |
Increased competition from emerging therapies |
| 2026 |
$19,500 |
Biosimilar entry or therapeutic developments |
| 2027 |
$18,500 |
Payer-driven discounts |
| 2028 |
$17,500 |
Market saturation, generic/biosimilar entry |
Key Market Risks
- Reimbursement constraints lower access and revenue.
- Competitive therapies such as CAR T cells and new monoclonals could diminish market share.
- Manufacturing costs affect profit margins. The complex infusion process adds logistical costs.
Key Takeaways
- NDC 68462-0585, Tafasitamab-cxix, is specialized for relapsed or refractory DLBCL.
- The current average treatment cycle price is approximately $22,000, with potential for gradual decline.
- Market competition is intensifying, especially from CAR T-cell therapies and biosimilars.
- Reimbursement policies will significantly influence eventual pricing and market share.
- Market growth depends on physician adoption, clinical outcomes, and logistical considerations for infusion protocols.
FAQs
Q1: What factors influence the price of Tafasitamab?
A1: Pricing is impacted by manufacturing costs, competition, reimbursement negotiations, and market demand.
Q2: How does Tafasitamab compare cost-wise with CAR T therapies?
A2: Tafasitamab costs around $20,000–$27,000 per cycle, whereas CAR T therapies can cost over $300,000–$400,000 per treatment.
Q3: Will biosimilars lower Tafasitamab’s price?
A3: Potentially, depending on regulatory approval, market entry, and competitive pressures.
Q4: How does the treatment protocol affect overall cost?
A4: The weekly infusion schedule over 12 weeks increases total treatment costs and logistical expenses.
Q5: What is the outlook for Tafasitamab’s market penetration?
A5: It is expected to increase as physician familiarity grows and if it demonstrates favorable cost-effectiveness relative to alternatives.
References
- FDA Drug Details – Minjuvi (Tafasitamab-cxix)
- IQVIA. "Pricing and Reimbursement Report," 2022.
- AAHC. "Market Data for DLBCL Therapies," 2022.
- EvaluatePharma. "Global Oncology Drug Sales," 2022.
- Centers for Disease Control and Prevention (CDC). "DLBCL Epidemiology," 2021.
