Last updated: April 1, 2026
What is NDC 62559-0424?
The National Drug Code (NDC) 62559-0424 is identified as Tafasitamab packaged with Lenalidomide. It is a combination therapy approved for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adult patients not suitable for autologous stem cell transplant.
Market Overview
Indications and Approvals
- Approved by the FDA in August 2020.
- Indicated for adult patients with relapsed or refractory DLBCL who are ineligible for autologous stem cell transplantation.
- It was developed by MorphoSys and has a biologic license agreement (BLA) in partnership with Incyte.
Market Size and Patient Demographics
- Estimated approximately 10,000–12,000 U.S. patients annually qualify for this treatment based on epidemiological data from the American Cancer Society [1].
- The treatment landscape for DLBCL includes other options such as R-CHOP, CAR-T therapies, and other monoclonal antibodies, making market penetration competitive.
Competitive Landscape
| Drug |
Indication |
Market Share (2022) |
Launch Date |
Pricing (Approximate) |
| Tafasitamab + Lenalidomide |
R/R DLBCL ineligible for SCT |
Limited, emerging |
August 2020 |
$11,000 per vial (varies) |
| Rituximab |
R/R DLBCL, first-line |
Dominant 60-70% |
1997 |
$4,500 per dose |
| Polatuzumab vedotin |
R/R DLBCL — combination therapy |
Growing |
2019 |
$26,000 per dose |
| CAR-T Therapies |
Relapsed DLBCL, highly active |
Rapid growth |
2017+ |
$373,000 median treatment cost |
Market Penetration
- Off-label use is limited.
- Adoption is hindered initially by high price and need for specialized infusion settings.
- Expected to grow with increasing awareness and evidence from ongoing studies.
Price Projections
Current Pricing
- Listed at approximately $11,000 per vial.
- The treatment course involves 4–6 doses, totaling approximately $44,000–$66,000 per patient, depending on dosing.
Price Trends (2023–2028)
| Year |
Estimated Price per Vial |
Rationale |
| 2023 |
$11,000 |
Current list price |
| 2024 |
$10,800 |
Slight discounting to improve uptake |
| 2025 |
$10,500 |
Price stabilization with increased volume sales |
| 2026 |
$10,200 |
Competition from biosimilars and similar biologics |
| 2027 |
$9,800 |
Cost optimization strategies |
| 2028 |
$9,500 |
Market saturation, patent expiration risks |
Influencing Factors
- Market growth: Driven by increased diagnosis, expanded indications, or new combination regimens.
- Pricing pressures: Competition with biosimilars, especially if patents expire or generic biologics enter the market.
- Regulatory decisions: Expansions or restrictions in approved indications can influence sales volume.
- Reimbursement policies: Payers' willingness to reimburse at current or reduced rates.
Investment and R&D Outlook
- Clinical trials are ongoing for broader indications, potentially increasing market size.
- Incorporation into first-line or earlier lines of therapy could reposition the drug.
- R&D is focused on reducing manufacturing costs and developing biosimilars.
Key Takeaways
- NDC 62559-0424 reflects the combination of Tafasitamab and Lenalidomide, with a current list price around $11,000 per vial.
- The market for relapsed/refractory DLBCL therapies is competitive, with CAR-T and other monoclonal antibodies leading.
- Future price declines are projected due to increased competition, patent expiry, and market saturation.
- Growth depends on expanding indications and clinical acceptance.
- Pricing strategies will influence volume sales and overall revenue trajectory.
FAQs
1. How does the price of NDC 62559-0424 compare with similar therapies?
Its current price (~$11,000/vial) is higher than rituximab but lower than CAR-T therapies, which often cost over $300,000 per treatment course.
2. What factors could significantly impact its market share?
Introduction of biosimilars, new competitors, changes in reimbursement policies, and expanding indications.
3. Are there ongoing clinical trials that could expand its use?
Yes, trials for earlier lines of therapy and combination regimens are ongoing, potentially broadening its market.
4. What is the likelihood of price reductions in the coming years?
High likelihood due to competitive pressures, patent expiration, and market saturation.
5. How might pricing negotiations with payers influence future prices?
Reimbursement negotiations may lead to price caps, impacting revenue and access.
References
[1] American Cancer Society. (2022). Cancer facts & figures 2022. https://cancerstatisticscenter.cancer.org
