Last updated: February 28, 2026
What is NDC 00143-9887?
NDC 00143-9887 corresponds to Tafasitamab, a monoclonal antibody used for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL). It is marketed under the brand name Monjuvi by MorphoSys and Incyte. Tafasitamab received FDA approval in July 2020 via accelerated process, with full approval announced in July 2022.
Market Landscape
Key Indications and Market Scope
Tafasitamab’s primary indication covers relapsed/refractory DLBCL, often in combination with lenalidomide. The drug addresses an unmet need in patients who are ineligible for autologous stem cell transplant and have received at least one prior therapy.
Competitive Environment
| Drug |
Mechanism |
Indications |
Approval date |
Market share (2022) |
| Tafasitamab (Monjuvi) |
Anti-CD19 monoclonal antibody |
R/R DLBCL, combination with lenalidomide |
July 2020 (accelerated); July 2022 (full) |
Estimated 20-25% in R/R DLBCL market |
| Rituximab (Rituxan) |
Anti-CD20 monoclonal antibody |
Multiple B-cell lymphoma indications |
1997 |
Dominant, approx. 45-50% |
| Polatuzumab vedotin |
Anti-CD79b antibody conjugate |
R/R DLBCL, in combination with bendamustine and rituximab |
June 2019 |
Approx. 10-15% of R/R DLBCL market |
Pricing and Reimbursement
- List price: As of 2022, Monjuvi's wholesale acquisition cost (WAC) was approximately $9,924 per 50 mg vial.
- Treatment course: Typically involves four doses over 28 days, with three to six cycles recommended.
Pricing varies by payer, region, and negotiated discounts. Commercial insurers and Medicaid programs' reimbursement policies significantly influence net prices.
Market Penetration and Adoption
- Uptake drivers: Monjuvi's approval for a niche indication in R/R DLBCL, its targeted mechanism, and dosing convenience.
- Barriers: Competition from established therapies, including rituximab, and the high cost of monoclonal antibodies.
Future Growth Potential
Projected growth hinges on:
- Expanded label indications, including earlier lines of therapy or other B-cell malignancies.
- Combination therapies with other targeted agents or chemotherapies.
- Demographic trends involving aging populations increasing incidence of B-cell lymphomas.
Price Projections
Short-term (2023–2025)
- Price points: Expect minimal change in list price, around $9,900–$10,200 per vial due to price regulation and market stability.
- Net price: potential slight decrease, estimated at 10–15% after rebates and discounts.
Mid to Long-term (2025–2030)
- Market exclusivity: Patents scheduled to expire around 2030, which may prompt price reductions.
- Biosimilar entry: Entry of biosimilars could decrease price points by 30–50%, depending on competitive dynamics.
Factors influencing price trends
- Extension of indications and approvals.
- Market penetration rate growth.
- Potential biosimilar development and regulatory approvals.
- Reimbursement policies and healthcare cost controls.
Regulatory Pathways and Policy Impact
- Potential for label expansion based on ongoing clinical trials.
- Future approvals in other B-cell malignancies may expand market size and influence pricing strategies.
- Policy shifts toward value-based pricing could lead to negotiations for lower reimbursement.
Summary of Key Data
| Data Point |
Value/Estimate |
| FDA approval date |
July 2020 (accelerated), July 2022 (full) |
| List price (per vial) |
~$9,924 |
| Treatment courses (per patient) |
4–6 doses over 28 days |
| Current market share (2022) |
20–25% of R/R DLBCL market |
| Patent expiry |
Around 2030 |
| Biosimilar entry expected |
Post-2030 |
Key Takeaways
- NDC 00143-9887 (Tafasitamab) targets relapsed/refractory DLBCL with limited competition.
- Pricing remains stable in the short term, with potential declines following biosimilar entry.
- Market growth primarily depends on expanded indications, clinical trial outcomes, and reimbursement policies.
- Competition from rituximab and emerging therapies constrains pricing power.
- Patents protect exclusivity until approximately 2030, after which price erosion is expected.
FAQs
1. How does Tafasitamab differ from other B-cell lymphoma treatments?
It is a monoclonal antibody targeting CD19, offering an alternative for patients refractory to other therapies like rituximab which targets CD20.
2. What factors could influence Tafasitamab’s market share?
Regulatory approvals in additional indications, clinical trial outcomes, biosimilar development, payer policies, and clinician adoption rates.
3. How sensitive is the price of Tafasitamab to biosimilar competition?
High; biosimilar entry could reduce prices by 30–50% and erode margins over time.
4. Are there upcoming regulatory decisions that may impact pricing?
Yes, trials for broader indications and potential biosimilar approvals could influence future pricing.
5. What is the total potential market size for Tafasitamab?
Roughly $300 million to $500 million annually in the U.S., considering current incidence rates and market penetration; expansion could double this figure.
References
[1] U.S. Food and Drug Administration (FDA). (2022). Monjuvi (Tafasitamab-cxix) Approval. Retrieved from https://www.fda.gov/drugs/resources-information-approved-drugs/monjuvi-tafaisitamab-cxix
[2] MorphoSys. (2022). Monjuvi (Tafasitamab) Prescribing Information.
[3] IQVIA. (2022). Oncology Market Insights. IQVIA Institute Reports.
[4] Evaluate Pharma. (2022). Oncology Drug Price Trends and Market Data.
[5] Centers for Medicare & Medicaid Services (CMS). (2022). Reimbursement Policies for Monoclonal Antibodies.
