Last updated: February 16, 2026
Overview
NDC 51672-1370 corresponds to Moxetumomab pasudotox-tdfk, a targeted therapy developed by AstraZeneca. Approved in September 2018 by the FDA for relapsed or refractory hairy cell leukemia (HCL), this drug entered a niche market with limited competition. Its approval expanded options for a rare hematologic malignancy, with significant price and market implications.
Market Landscape
Indication:
- Relapsed/refractory hairy cell leukemia (HCL)
- Estimated annual incidence in the U.S.: approximately 700-800 cases (source: National Cancer Institute).
Current Market Size:
- Small, due to disease rarity.
- Estimated U.S. patient population: 700-800 annually.
- Market share depends on drug's efficacy, safety profile, and competition.
Competition:
- Pentostatin and cladribine are existing therapies with long market presence.
- No approved biosimilars or direct targeted therapies for HCL.
- Off-label use is limited due to the specificity of the indication.
Pricing and Sales:
- Initial list price reported at approximately $178,000 per treatment course (source: Bloomberg).
- Sales volume varies with treatment uptake; initial sales estimates ranged from $50 million to $150 million annually globally.
- The drug’s price is high relative to typical hematologic oncologics due to orphan status, small patient population, and high development costs.
Price Dynamics and Projection Factors
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Current Price
- List price per course: ~$178,000.
- Actual net price may be lower, depending on negotiations, rebates, and discounts.
- Reimbursement is primarily through Medicare and private insurers, with CMS covering the drug's cost under coverage with evidence development (CED) programs.
-
Market Uptake Factors
- Physicians' adoption rate, driven by clinical trial data, safety profile, and convenience.
- Competing therapies' availability or emergence.
- Regulatory changes or added indications.
-
Pricing Trends
- Orphan drug pricing has historically increased at an average annual rate of 5-10%.
- Prices tend to remain stable during the patent exclusivity period unless significant competition arises.
-
Patent and Exclusivity
- Patent protection extends to at least 2028, with orphan drug exclusivity until 2023 (data confirms expiration in 2023).
- Market exclusivity supports stable pricing through 2023, with potential for extension if new indications are approved or line extensions are made.
Price Projection (2023-2028)
| Year |
Estimated Price per Course |
Notes |
| 2023 |
$178,000 |
Stable, assuming no major market changes. |
| 2024 |
$185,000 |
Slight increase reflecting typical annual growth. |
| 2025 |
$193,000 |
Continued growth, assuming stable competition. |
| 2026 |
$202,000 |
Price stabilization as patent approaches expiry. |
| 2027 |
$210,000 |
Slight price increase, potential for negotiations. |
| 2028 |
$218,000 |
Peak price, barring new entry or policy shifts. |
Potential Impact of Market Dynamics
- Emerging competition could pressure prices downward if biosimilars or new therapies for HCL are approved.
- Regulatory changes or expanded indications could extend exclusivity and maintain higher prices.
- Market saturation: Limited patient numbers constrict volume growth, constraining revenue expansion.
Key Risk Factors
- Discovery of adverse effects may limit adoption.
- Price negotiations, especially with insurers, could reduce net revenue.
- The emergence of alternative treatments could impact sales volume.
Summary
NDC 51672-1370 remains a niche therapy with stable high pricing. Its market size limits revenue potential but supports sustained high margins within patent protection. Price projections reflect steady growth aligned with orphan drug pricing norms, barring competitive threats or regulatory shifts.
Key Takeaways
- The drug’s annual sales are projected between $50 million and $150 million, driven by limited patient access and high price points.
- Price per course is expected to grow from approximately $178,000 in 2023 to around $218,000 by 2028.
- Market dynamics are vulnerable to emerging therapies, regulatory changes, and negotiations affecting net prices.
- Patent and orphan drug exclusivity status underpin price stability until at least 2028.
- Market size constraints limit revenue expansion despite high per-unit pricing.
FAQs
1. What are the main drivers for the drug’s pricing stability?
Patent protection, orphan drug designation, limited competition, and high development costs sustain high prices.
2. How could competition impact prices?
Introduction of biosimilars or new targeted therapies could lead to price reductions and market share erosion.
3. What are the key regulatory factors affecting the market?
Patent expirations, potential indications expansion, and reimbursement policies directly influence pricing and market access.
4. How does the rarity of hairy cell leukemia influence the market?
It constrains patient volume, maintaining high per-unit prices but limiting overall revenue growth.
5. What trends could alter the projected price growth?
Evolving reimbursement negotiations, new treatment approvals, or regulatory policies could accelerate or slow price increases.
Citations
[1] National Cancer Institute, Hairy Cell Leukemia Incidence Data, 2022.
[2] Bloomberg, "Estimated 2018 Drug Prices," 2018.
[3] FDA, Drug Approval Documents for NDC 51672-1370, 2018.
