Last updated: February 15, 2026
What is NDC 51672-4130?
NDC 51672-4130 is a drug marketed under the brand name Blincyto. It is an immunotherapy used for treating certain types of adult acute lymphoblastic leukemia (ALL). This drug contains blinatumomab, a bispecific T-cell engager (BiTE) antibody construct designed to target CD19-positive B-cell precursor ALL.
Market Overview
Indications & Usage:
Blincyto is approved for relapsed or refractory B-cell precursor ALL, a rare and aggressive leukemia. The prevalence of adult ALL in the U.S. is estimated at approximately 1.2 cases per 100,000, with around 6,000 new cases annually [1].
Competitive Landscape:
- Kymriah (tisagenlecleucel) by Novartis: CAR-T cell therapy, similar indication, priced at approximately $475,000 per treatment.
- Tecartus (brexucabtagene autoleucel): Also CAR-T, ~$373,000 per course.
- Other options: Chemotherapy and stem cell transplantation, with significantly lower costs.
Market Dynamics:
Blincyto entered the market in 2016, with steady sales growth driven by expanding indications, including minimal residual disease (MRD)-positive cases. Its role as both a first-line therapy in specific populations and as salvage therapy sustains its demand.
Regulatory Status & Approvals:
- Approved by FDA in 2014 for Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL.
- Expanded indications over time, including activity in additional subpopulations [2].
Current Pricing and Cost Factors
List Price:
Blincyto’s wholesale acquisition cost (WAC) per treatment cycle is approximately $178,000, based on an average dose of 38 mcg/day over 28 days, with dosing adjusted for patient weight [3].
Cost Drivers:
- Drug acquisition costs
- Administration expenses (IV infusion, hospitalization)
- Monitoring and adverse event management
Reimbursement & Market Access:
Insurance coverage and hospital negotiations influence actual costs. Many payers require prior authorization, influencing access.
Price Projections
Factors Influencing Future Pricing:
- Competition from CAR-T therapies (Kymriah, Tecartus) which are priced higher but are single-use treatments, potentially impacting Blincyto's positioning.
- Expanded indications or combination therapies may justify price adjustments.
- Patent protections extending into the late 2020s limit generic or biosimilar entry, maintaining pricing power.
Projection Scenarios:
| Scenario |
Price Trend |
Rationale |
| Conservative (downward) |
Slight decrease (~5-10%) over 3 years |
Market pressure from biosimilars or new therapies |
| Moderate (stable) |
Prices remain stable with minor fluctuations |
Continued demand due to unmet needs |
| Aggressive (increase) |
10-15% increase driven by new indications or premium positioning |
Label expansions or strategic pricing decisions |
Estimated Price Range (2023-2026):
- Low end: ~$160,000 per treatment cycle
- High end: ~$200,000 per treatment cycle
Market Risks & Opportunities
Risks:
- Entry of biosimilar products after patent expiry (~2026) could reduce prices.
- New immunotherapies or CAR-T treatments may limit market share.
- Reimbursement challenges depending on healthcare policy shifts.
Opportunities:
- Broadening indications (e.g., earlier lines of therapy).
- Combination regimens improving efficacy and driving higher pricing tiers.
- International expansion increasing overall revenue.
Key Takeaways
- NDC 51672-4130 (Blincyto) generates approximately $178,000 per treatment cycle in the U.S.
- The drug faces competition from CAR-T therapies and declining costs due to biosimilar entry.
- Price projections suggest stability with potential slight decreases or increases depending on market developments.
- Expansion of indications and clinical trial results could influence future pricing strategies.
FAQs
1. How does Blincyto compare to CAR-T therapies in cost?
Blincyto’s cost per cycle is roughly $178,000, whereas CAR-T therapies like Kymriah cost around $475,000 per treatment but are single-dose infusions. Blincyto's multiple-cycle use spreads costs over time, potentially affordability-driven.
2. What are the main drivers of Blincyto's market demand?
Demand stems from its FDA approvals for relapsed/refractory ALL and expanded indications, especially in patients unsuitable for stem cell transplantation.
3. How might biosimilars impact the price of Blincyto?
Entry of biosimilars post-2026 could lead to significant price reductions, similar to other biologics eroding orphan drug exclusivity.
4. Are there upcoming regulatory decisions that could influence pricing?
Yes, ongoing trials for earlier-line use and combination therapies could lead to label expansions, possibly increasing value and pricing.
5. What are the regulatory barriers for biosimilar entry?
Patent protections and biologics licensing pathways create hurdles; biosimilar approvals require demonstrating high similarity, which can be complex and costly.
Citations
[1] American Cancer Society. "Adult Acute Lymphoblastic Leukemia," 2021.
[2] FDA. Blincyto (blinatumomab) prescribing information. 2014.
[3] Bloomberg Intelligence. "Biotech Pricing Trends," 2022.
[4] IQVIA. "Market Dynamics & Biosimilar Entry," 2022.