Last updated: February 24, 2026
What is NDC 62135-0835?
NDC 62135-0835 is a specific National Drug Code (NDC) assigned to a pharmaceutical product. According to available FDA and commercial databases, this NDC corresponds to Tafasitamab (monotherapy), marketed as Monjuvi.
Product Overview
- Active Ingredient: Tafasitamab
- Indications: Relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including cases with prior therapies.
- Formulation: Injection
- Approval Date: February 2020 (FDA approval for Monjuvi)
Market Landscape
Competitive Context
Tafasitamab/Monjuvi is positioned within the B-cell lymphoma treatment segment, competing primarily with CAR-T therapies and monoclonal antibodies such as rituximab.
- Key competitors:
- Rituximab (Rituxan)
- Polatuzumab vedotin (Polivy)
- CAR-T therapies (Yescarta, Kymriah)
Market Size
- Global B-cell lymphoma treatment market estimate (2022): $8.3 billion
- Market segment for tafasitamab (2022): Approximately $600-800 million domestically, with growth driven by unmet needs in relapsed/refractory cases.
Market Drivers
- Rising incidence of B-cell lymphomas worldwide.
- Limited options for relapsed/refractory patient populations.
- Increasing adoption of monoclonal antibody therapies.
Market Challenges
- High treatment costs associated with targeted therapies.
- Competition from established and emerging CAR-T therapies.
- Reimbursement hurdles impacting adoption.
Price Dynamics and Projections
Current Pricing
- Average wholesale price (AWP): Approximately $1,300 per 20 mg vial.
- Typical regimen: 12 mg/kg intravenous infusion administered on days 1 and 15 of cycle 1, then day 1 of subsequent cycles.
- Per-treatment cost estimate: $17,000 — $20,000, depending on patient weight and treatment cycles.
Pricing Trends
- Monjuvi entered the market with an pricing strategy comparable to other monoclonal antibody treatments.
- No significant discounts or price reductions seen to date.
- Reimbursement policies influence net prices.
Future Price Projections (Next 3-5 Years)
| Year |
Price Estimate |
Factors Affecting Price |
| 2023 |
$1,250 - $1,350 per vial |
Stable pricing due to limited competition and patent exclusivity. |
| 2024 |
$1,200 - $1,350 per vial |
Potential price stabilization; manufacturing efficiencies may marginally lower costs. |
| 2025 |
$1,150 - $1,300 per vial |
Possible price reduction driven by broader biosimilar entry or generics, though no biosimilar announced yet. |
| 2026 |
$1,100 - $1,250 per vial |
Market saturation and pricing pressures might lead to slight decreases. |
Impact of Biosimilars
- No biosimilars for tafasitamab have been approved as of now.
- Patent protection extends to at least 2030, maintaining pricing power.
Market Entry and Regulatory Factors
- Pricing regulations: In the U.S., no direct regulation of drug prices exists, but Medicare and private insurers influence final prices via formulary decisions.
- Reimbursement: Medicare coverage for monoclonal antibodies typically aligns with ASP (Average Sales Price) plus a 6% markup.
- Potential for biosimilar development: A biosimilar pathway might emerge between 2028-2030, potentially reducing prices.
Key Takeaways
- NDC 62135-0835 (Tafasitamab/Monjuvi) operates in a niche of relapsed/refractory B-cell lymphoma treatment.
- The current price of approximately $1,300 per vial is stable but expected to decline gradually over the next five years.
- Market growth is driven by unmet clinical needs and high adoption barriers for competing therapies.
- Entry of biosimilars could significantly impact pricing and market share, but no biosimilars are currently in advanced development phases.
FAQs
What are the primary drivers influencing the price of NDC 62135-0835?
Manufacturing costs, patent protections, market competition, reimbursement policies, and clinical demand drive the pricing stability or decline.
How does the product compare with similar therapies in terms of cost?
Monjuvi's pricing is comparable to other monoclonal antibodies used in hematology, often around $1,200-$1,350 per vial, with some variation based on dosing and market dynamics.
When might biosimilars influence prices significantly?
Biosimilar development often takes 8-10 years for approval after patent expiration, projected around 2028-2030 for tafasitamab, which could lower prices.
What are the barriers to entry for biosimilars in this segment?
Patent protections, regulatory hurdles, and clinical trial requirements limit biosimilar entry. Market size and reimbursement also influence investment decisions.
What is the outlook for the therapeutic landscape related to this NDC?
The landscape will evolve with advances in CAR-T and bispecific modalities, but monoclonal antibodies like tafasitamab maintain relevance for specific patient populations.
References
- Food and Drug Administration (FDA). (2020). FDA Approval: Monjuvi (Tafasitamab-cxix). [https://www.fda.gov]
- IQVIA. (2022). The U.S. Market for Hematology Oncology Drugs.
- SSR Health. (2022). Estimated U.S. Net Prices for Oncology Drugs.
- EvaluatePharma. (2022). World Preview 2022: Outlook to 2027.
- U.S. Patent and Trademark Office. (2023). Patent status for tafasitamab.
