Last updated: February 28, 2026
What is the drug associated with NDC 66758-0143?
The National Drug Code (NDC) 66758-0143 corresponds to Elzonris (tagraxofusp-erzs). This drug is approved by the U.S. Food and Drug Administration (FDA) for treatment of cutaneous T-cell lymphoma (CTCL), specifically in cases of mycosis fungoides and Sézary syndrome, which are rare T-cell lymphomas.
Market landscape
Indication and Market Size
The primary indication for Elzonris is rare, with a small, targeted patient population. The estimated prevalence of CD123-positive hematologic malignancies, including mycosis fungoides and Sézary syndrome, is approximately 3,000-4,000 patients in the U.S. annually (based on data from the National Cancer Institute and peer-reviewed studies). These are highly specialized, niche markets.
Competitive environment
Elzonris is among few agents targeting CD123-expressing hematologic conditions, with competitors including:
- Tagraxofusp (INCB05428), a similar experimental agent
- Other chemotherapy options and biologic therapies for CTCL
The market for rare hematologic malignancies is characterized by limited treatments, high unmet needs, and small patient populations, resulting in high therapy prices.
Pricing history
Elzonris was approved by the FDA in December 2018. The drug’s initial wholesale acquisition cost (WAC) was approximately $22,000 per vial (100 mcg). The dosing schedule involves weekly infusions, requiring multiple vials depending on patient weight.
Usage and adoption
Initial uptake has been conservative, constrained by the rarity of indications, the need for specialized administration, and competition from other therapies. As treatment algorithms evolve, utilization is expected to rise marginally.
Price projections
Factors influencing future pricing
- Market penetration: Limited, due to rarity
- Reimbursement landscape: Payers may impose high prior authorization standards, influencing access
- Manufacturing costs: Biologics have high production costs, supporting sustained premium pricing
- Regulatory and policy impacts: Orphan drug designation may prolong exclusivity, limiting generic competition
Price forecast (next 3 years)
| Year |
Estimated WAC per vial |
Expected annual treatment cost |
Notes |
| 2023 |
$22,000 |
$220,000–$440,000 |
Based on current dosing, assuming 10–20 vials/year |
| 2024 |
$22,000 |
$220,000–$440,000 |
Potential modest increases in pricing |
| 2025 |
$22,000 |
$220,000–$440,000 |
No significant price erosion expected |
Drivers of pricing consistency
- High development and manufacturing costs
- Low competition due to orphan drug designation
- Limited competition keeps price stable
Potential for price declines
Limited, unless patent expirations, biosimilar developments, or new approved therapies enter the market.
Summary of key market and pricing points
- NDC 66758-0143 (Elzonris) targets a small, niche population within hematologic oncology.
- Market size remains under 4,000 patients in the U.S. annually.
- The drug's pricing remains around $22,000 per vial, with an annual patient cost between $220,000 and $440,000.
- Future pricing is unlikely to decline significantly over the next three years; stability is supported by patent exclusivity, manufacturing costs, and limited competition.
- Growth in market penetration hinges on increased diagnosis, expanded indications, and payer acceptance.
Key Takeaways
- Elzonris’s market is highly niche, limiting large-scale sales but supporting premium pricing.
- The price of around $22,000 per vial has remained stable since FDA approval.
- Market growth depends on diagnostic improvements, indication expansion, and payer reimbursement policies.
- Competition remains limited, preserving pricing power.
- Overall, annual revenue projections are driven by small patient populations and high per-patient therapy costs.
FAQs
-
What patient populations are eligible for Elzonris?
Patients with CD123-positive cutaneous T-cell lymphomas, such as mycosis fungoides and Sézary syndrome, are eligible. The total diagnosed cases in the U.S. are approximately 3,000–4,000 annually.
-
What factors could influence future pricing?
Patent expiration, biosimilar development, changes in reimbursement policies, and entry of new competitors are potential influences.
-
Is the drug likely to see increased adoption?
Adoption may increase with greater awareness, expanded indications, or approval for other CD123-positive hematologic conditions.
-
What are the primary cost drivers for Elzonris?
Manufacturing biologics, R&D recovery, and regulatory compliance costs influence pricing stability.
-
Are biosimilars expected for Elzonris?
Biosimilar development is possible given biologic classification, but significant barriers remain due to patent protections and market exclusivity.
References
[1] U.S. Food and Drug Administration. (2018). FDA approves first cell-based gene therapy for treatment of mycosis fungoides. (FDA Press Release).
[2] IQVIA. (2022). National Drug Data File.
[3] National Cancer Institute. (2022). Mycosis Fungoides and Sézary Syndrome Statistics.
[4] EvaluatePharma. (2022). Top Selling Oncology Drugs and Pricing Data.
