Last updated: February 25, 2026
What Is the Drug with NDC 13668-0341?
NDC 13668-0341 corresponds to Tafasitamab-cxix (monotherapy), marketed under the brand Monjuvi by Morphosys AG. It is a CD19-targeting monoclonal antibody approved by the FDA in 2020 for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). As an immunotherapy, it offers a targeted approach for specific hematologic malignancies.
Market Size and Demographics
Indications and Patient Population
- Primary Use: Treatment of relapsed/refractory DLBCL after at least one prior therapy.
- Estimated Patient Population: Approximately 11,000 patients annually in the U.S. (based on epidemiology data from the American Cancer Society).
- Global Market Potential: Extends to Europe and parts of Asia with similar indications, adding an estimated 15,000-20,000 eligible patients globally.
Competitive Landscape
- Direct Competitors: R-CHOP regimen, CAR-T therapies (e.g., axi-cel, tisa-cel), other monoclonal antibodies like Polatuzumab vedotin.
- Market Share Estimate: Based on current usage patterns, Monjuvi captures approximately 10-15% of the relapsed/refractory DLBCL treatment market, with potential to expand as approvals for earlier-line therapy develop.
Price and Revenue Projections
Current Pricing
- Wholesale Acquisition Cost (WAC): Approximately $18,000 per 50 mg vial.
- Typical Dose: 12 mg/kg IV every 21 days.
- Average Treatment Course: 6 to 8 cycles, costing around $110,000 to $150,000 per patient.
Revenue Estimations
| Parameter |
Assumption |
Calculation |
Result |
| Patients treated annually |
1,650 (15% of eligible) |
11,000 x 15% |
1,650 |
| Average treatment cost |
$130,000 |
- |
- |
| Total U.S. market |
1,650 x $130,000 |
- |
$214.5 million annually |
Global sales could double U.S. figures, assuming similar uptake and patient volume.
Price Trend Predictions
- Short-Term (1-2 years): Prices remain stable as supply contracts and reimbursement policies are solidified.
- Medium-Term (3-5 years): Potential drop of 10-15% as biosimilar or authorized generic entries could emerge, though no biosimilars are currently approved.
- Long-Term (5+ years): Market saturation and expanded indications may lower per-treatment costs, but new combination regimens might sustain or increase revenue.
Regulatory and Reimbursement Factors
- FDA approvals: 2020 for relapsed/refractory DLBCL.
- Reimbursement landscape: Centers for Medicare & Medicaid Services (CMS) and private insurers largely reimburse at the WAC price, with some negotiations potentially reducing net costs.
- Pricing pressure: Emerging biosimilars and increased competition could influence pricing dynamics.
Risks and Opportunities
Risks
- Market penetration slower than expected due to existing therapies.
- Introduction of biosimilars could reduce prices.
- Reimbursement challenges may constrain revenues.
Opportunities
- Approvals for earlier lines of therapy.
- Combination therapies with other approved agents.
- Expansion into international markets with growing hematology oncology programs.
Key Takeaways
- NDC 13668-0341 (Tafasitamab-cxix) is a monoclonal antibody targeting CD19, approved since 2020 for relapsed/refractory DLBCL.
- The U.S. market is characterized by an initial price of approximately $130,000 per treatment course.
- Estimated U.S. revenue potential is around $215 million annually, with global numbers potentially doubling this figure.
- Pricing stability is likely in the short term; long-term declines depend on biosimilar development, regulatory changes, and competitive dynamics.
- Growing indications and combination therapies can positively impact market size and profitability.
FAQs
1. What is the primary indication for NDC 13668-0341?
Treatment of relapsed or refractory diffuse large B-cell lymphoma in adult patients who have received at least one prior therapy.
2. How does the price of Monjuvi compare to similar therapies?
It is comparable to other monoclonal antibody treatments in hematologic oncology, priced around $130,000-$150,000 per course; CAR-T therapies can cost up to $400,000 and more.
3. What potential factors could impact future pricing?
Introduction of biosimilars, reimbursement policies, changes in indication approvals, and competitive therapies.
4. Can the market for NDC 13668-0341 expand beyond relapsed/refractory settings?
Yes, if FDA approves new indications for earlier lines of therapy or combination regimens.
5. Are there approved biosimilars for Tafasitamab?
As of now, no biosimilars have been approved; development is ongoing in the biosimilar pipeline for monoclonal antibodies.
References
[1] U.S. Food and Drug Administration. (2020). FDA approves Monjuvi for relapsed or refractory diffuse large B-cell lymphoma. Retrieved from https://www.fda.gov
[2] American Cancer Society. (2022). Key statistics for non-Hodgkin lymphoma. Retrieved from https://cancer.org
[3] IQVIA. (2022). Market Dynamics of Hematological Oncology Treatments. IQVIA Reports.
[4] EvaluatePharma. (2022). Global Oncology Market Forecast. Evaluate Ltd.
[5] Center for Drug Evaluation and Research. (2022). Biosimilar Development and Regulatory Policies. FDA.
Note: Data is based on public sources and market estimates as of 2023.
