Last updated: March 2, 2026
What is the drug associated with NDC 57664-0393?
The National Drug Code (NDC) 57664-0393 corresponds to Caplacizumab-yhdp (brand name Cablivi), used for treating thrombotic thrombocytopenic purpura (TTP). It is an injectable monoclonal antibody developed by Ablynx, now a part of Sanofi.
Market Landscape
Therapeutic Area and Competition
Caplacizumab is approved for acquired TTP, a rare, life-threatening blood disorder. The TTP market is characterized by limited treatment options and small patient populations.
Key competitors:
- Plasma exchange (standard of care)
- Immunosuppressants (e.g., corticosteroids)
- Investigational agents, including emerging biologics and small molecules
Market Size
Approximately 4-8 cases per million people annually in the U.S. (based on published epidemiology). The U.S. population incidence estimates:
| Parameter |
Estimate |
| Annual U.S. cases |
1,300 - 2,600 (based on 330 million population) |
| Active treated patients |
1,200 - 2,400 (considering diagnosis and treatment rates) |
Worldwide, TTP prevalence is similar, with growing awareness increasing diagnosis rates.
Current Market Penetration
As of 2023, Caplacizumab has achieved limited market penetration due to the specialty nature of TTP and high drug costs. Distribution is concentrated in tertiary care centers and specialized hematology clinics.
Adoption Barriers
- High price point: The drug's list price exceeds $200,000 per treatment course.
- Reimbursement challenges due to small patient population.
- Competition from plasma exchange remains the standard, although Caplacizumab offers convenience and survivability benefits.
Price Analysis and Projections
Current Pricing
In 2022, the listed wholesale acquisition cost (WAC) for a single dose of Caplacizumab is approximately $14,000 to $20,000. The typical treatment regimen:
- Average of 4 doses per patient
- Total treatment course costs ~$56,000 to $80,000
Cost Drivers
- WAC per dose: ~$15,000
- Total treatment cost: ~$60,000
- Additional costs: Monitoring, hospitalization, supportive care
Market Projections
| Year |
Estimated Patient Population |
Expected Market Penetration |
Revenue Estimate |
Comments |
| 2023 |
1,300 – 2,600 |
20% |
$15M – $40M |
Limited adoption, primarily in specialized centers |
| 2025 |
1,500 – 3,000 |
30% |
$25M – $70M |
Increased familiarity, expanded payer coverage |
| 2030 |
2,000 – 4,000 |
50% |
$40M – $120M |
Broader recognition, potential price adjustments |
Price Sensitivity
Higher prices constrain payer reimbursement, limiting market share. Cost-effectiveness analyses favor the drug due to improved survival and reduced hospitalization, supporting potential for price adjustments or value-based pricing.
Future Pricing Trends
- Price reductions in high-cost biologics are common over time.
- Biosimilar competition unlikely soon due to manufacturing complexity and patent protections.
- Pricing could stabilize around current levels unless new competitors or reimbursement shifts occur.
Policy and Regulatory Factors Impacting Pricing
- FDA approval grants exclusivity until 2030.
- Medicaid rebate requirements influence net prices.
- Pricing reforms and increased emphasis on value-based arrangements may pressure downward adjustments.
Summary
Caplacizumab's niche market confines its revenue potential but also supports continued high pricing. Market expansion will depend on increasing diagnosis rates, payer acceptance, and potential label expansions. Price projections suggest stable or slightly declining list prices over the next five years, with revenues contingent on market penetration.
Key Takeaways
- NDC 57664-0393 (Caplacizumab) remains a high-price, small-market biologic for TTP.
- The U.S. market size is small but growing, with revenues estimated between $15 million and $70 million through 2025.
- Price per dose stays around $15,000, with total treatment costs averaging $60,000.
- Market growth hinges on increased awareness, expanded indications, and payer reimbursement strategies.
- Long-term stability or modest price decreases are likely, barring significant regulatory or competitive changes.
FAQs
Q1: What factors limit the market size for Caplacizumab?
The rarity of TTP restricts the patient population, capping potential sales.
Q2: How does the drug's pricing compare to other biologics?
Prices are comparable to other monoclonal antibodies used for rare diseases; biologics for ultra-rare conditions typically range from $100,000 to $200,000 per year.
Q3: Is there a potential for biosimilar entry?
Biosimilar development is unlikely until patent exclusivity expires around 2030, given manufacturing complexities.
Q4: How might reimbursement policies impact future sales?
Positive payer coverage and indication expansion could boost sales, whereas restrictive reimbursement policies could limit market growth.
Q5: Are there prospects for new competitors in the TTP market?
Emerging biologics or small molecules are under investigation but none have gained regulatory approval as of 2023.
References
[1] Food and Drug Administration. (2019). Cablivi (caplacizumab-yhdp) prescribing information.
[2] MarketWatch. (2022). Biologic drug pricing trends.
[3] National Organization for Rare Disorders. (2021). Thrombotic Thrombocytopenic Purpura facts.
[4] IQVIA. (2022). Global biologics market report.
[5] FDA. (2021). Orphan Drug Designation and incentives.
