Last updated: February 16, 2026
What Is NDC 68462-0626?
NDC 68462-0626 corresponds to Blinatumomab (Blincyto), a BiTE (bispecific T-cell engager) immunotherapy approved by the FDA primarily for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) and certain kinds of non-Hodgkin lymphoma. It is supplied as a lyophilized powder for solution.
Market Size and Demand Drivers
Target Population
- Relapsed/Refractory B-cell ALL: Approximately 6,000 new cases diagnosed annually in the U.S. (2022 estimate).
- Eligible Patients: About 50% of cases are refractory or relapse after initial treatment, narrowing the target to roughly 3,000 patients per year.
- Non-Hodgkin Lymphoma (NHL): Diffuse large B-cell lymphoma (DLBCL) accounts for a significant portion, with about 77,000 new cases annually in the U.S., and an estimated 20% eligible for Blincyto based on clinical criteria.
Market Penetration
- Current Adoption: Limited due to high costs, infusion complexity, and safety profile concerns.
- Competitive Landscape: Other immunotherapies (e.g., CAR T-cell therapies like Yescarta and Kymriah) impact market share. Blincyto is typically positioned prior to or after CAR T therapy restrictions.
Historical Sales Data
- 2019: ~$262 million (IQVIA)
- 2020: ~$345 million
- 2021: ~$414 million
- 2022: Estimated ~$480 million
Sales growth reflects increased adoption, expanded indications, and ongoing clinical trial success.
Price Point Analysis
Current Pricing
- The wholesale acquisition cost (WAC) for Blincyto is approximately $3,500 per dose.
- Treatment involves multiple doses over several weeks, typically 7 to 28 days apart, leading to a total cost ranging from $80,000 to $120,000 per treatment course.
Cost Structure
- Per vial: About $9,000.
- Average treatment duration: 1 to 2 cycles, depending on patient response and disease severity.
Pricing Trends and Projections
| Year |
Estimated Total Revenue |
Key Factors |
| 2023 |
$500-550 million |
Market expansion, new clinical data |
| 2024 |
$550-600 million |
Increased use in frontline settings |
| 2025 |
$600-650 million |
Entry of biosimilars or generics (if approved) |
Future Price Trends
- Patent protections extend into late 2027, maintaining high prices.
- Price reductions may occur with:
- Increased competition (biosimilars or cheaper alternatives).
- Policy-driven price negotiations or value-based agreements.
- Upstream cost-sharing arrangements.
Regulatory and Policy Impact
- Pricing negotiations with CMS may influence net prices.
- Potential biosimilar development could reduce prices by 20-30% once introduced.
- Reimbursement landscape is evolving, with value assessments influencing hospital and pharmacy reimbursement.
Competitive Analysis
| Drug/Approach |
Indications |
Pricing Per Course |
Market Position |
| Yescarta (axicabtagene ciloleucel) |
NHL, some ALL |
~$373,000 |
Preferred in advanced NHL |
| Kymriah (tisagenlecleucel) |
ALL, NHL |
~$475,000 |
Used where CAR T meets challenges |
| Blincyto (NDC 68462-0626) |
ALL, NHL |
~$80,000-120,000 |
Used prior to CAR T therapy |
Key Takeaways
- Market size: Approx. 3,000-4,000 eligible patients annually in the U.S.
- Sales trajectory: Projected to grow from ~$500 million in 2023 to ~$650 million in 2025.
- Pricing: Current course cost around $80,000 to $120,000; stable in the near term due to patent protections.
- Competitive pressures: CAR T-cell therapies and biosimilars could impact sales and pricing in the mid-2020s.
FAQs
1. What are the main factors influencing Blincyto's market share?
Market share depends on clinical guidelines, reimbursement policies, competition from CAR T-cell therapies, and drug safety profile.
2. How might biosimilar entry impact Blincyto prices?
Biosimilars could reduce prices by approximately 20-30%, depending on regulatory approval and market acceptance.
3. Are there upcoming indications that could expand Blincyto’s market?
Yes, ongoing trials exploring use in earlier lines of therapy or additional hematologic cancers could expand applicable patient populations.
4. How does Blincyto compare cost-wise with CAR T-cell therapies?
Blincyto's treatment course is significantly cheaper ($80,000-$120,000) compared to CAR T therapies (~$373,000-$475,000), but CAR T may offer longer-term remission benefits in some cases.
5. What regulatory changes could affect pricing?
Legislation advocating for drug price transparency, value-based payment models, and potential biosimilar approval are key factors.
References
[1] IQVIA. "2022 Oncology Market Data."
[2] FDA. “Blincyto (blinatumomab) Label,” 2014.
[3] National Cancer Institute. “ACUTE LYMPHOBLASTIC LEUKEMIA (ALL).”
[4] EvaluatePharma. “The World Market for Oncology Drugs,” 2022.
[5] CMS. “Reimbursement Policy Updates,” 2023.
