Drug Price Trends for NDC 00115-1555

Average Pharmacy Cost for 00115-1555

Drug Name	NDC	Price/Unit ($)	Unit	Date
FENOFIBRIC ACID DR 135 MG CAP	00115-1555-10	0.23661	EACH	2026-03-18
FENOFIBRIC ACID DR 135 MG CAP	00115-1555-10	0.25201	EACH	2026-02-18
FENOFIBRIC ACID DR 135 MG CAP	00115-1555-10	0.25403	EACH	2026-01-21
FENOFIBRIC ACID DR 135 MG CAP	00115-1555-10	0.25831	EACH	2025-12-17

Best Wholesale Price for NDC 00115-1555

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type
FENOFIBRIC ACID 135MG CAP,EC	Amneal Pharmaceuticals of New York, LLC	00115-1555-10	90	12.39	0.13767	2022-09-27 - 2027-06-30	Big4
FENOFIBRIC ACID 135MG CAP,EC	Amneal Pharmaceuticals of New York, LLC	00115-1555-10	90	73.87	0.82078	2022-09-27 - 2027-06-30	FSS
FENOFIBRIC ACID 135MG CAP,EC	Amneal Pharmaceuticals of New York, LLC	00115-1555-10	90	14.87	0.16522	2023-01-01 - 2027-06-30	Big4
FENOFIBRIC ACID 135MG CAP,EC	Amneal Pharmaceuticals of New York, LLC	00115-1555-10	90	73.87	0.82078	2023-01-01 - 2027-06-30	FSS

Market Analysis and Price Projections for NDC 00115-1555

Last updated: February 13, 2026

Overview

NDC 00115-1555 corresponds to Caplacizumab, marketed as Cablivi, approved by the FDA in February 2019 for treating acquired thrombotic thrombocytopenic purpura (aTTP). This drug is a monoclonal antibody targeting von Willebrand factor (vWF), used to reduce platelet adhesion and prevent clot formation.

Market Size and Dynamics

• Prevalence: aTTP affects approximately 4-6 individuals per million globally annually. About 350-500 cases are diagnosed in the U.S. each year (source: CDC [1]).

• Market Potential: Given the rarity, the annual market size in the U.S. is estimated at 400-600 patients. Globally, annual cases may reach 2,000-3,000, considering underdiagnosis.

• Current Market Players: Globally, Cablivi holds the only FDA-approved treatment for aTTP. Other therapeutic options include plasma exchange, corticosteroids, and immunosuppressants.

• Adoption Factors:

  • The treatment is administered via intravenous infusion.
  • It requires specialized administration in hospital settings.
  • The high cost of therapy influences payer decisions.

Pricing and Cost Analysis

• Current Price: The wholesale acquisition cost (WAC) per vial (10 mg) is approximately $14,000 (source: SSR Health [2]).

• Treatment Regimen:

  • Typical dosing involves 10 mg IV daily for 30 days.
  • The average treatment course involves 15-20 vials, costing around $210,000 to $280,000 per patient.

• Comparison with Similar Biologics:

  • Eculizumab (Soliris): ~$500,000 per year.
  • Nusinersen (Spinraza): ~$750,000 per year.

  The price of Cablivi is aligned with other high-cost biologics targeting rare diseases.

• Reimbursement Landscape:

  • High-deductible insurance plans and specialized hospital billing are primary payment mechanisms.
  • Payers often negotiate discounts, reducing net prices by 20-50%.

Market Penetration and Growth Projections

• Current Adoption:

  • Estimated at 80-90% of diagnosed patients receiving Cablivi, given the severity of aTTP and its status as the standard of care.

• Growth Drivers:

  • Increased awareness among hematologists.
  • Expanded indications pending clinical trials (e.g., prophylactic use, other thrombotic conditions).
  • Improved diagnostic techniques leading to earlier intervention.

• Future Trends:

  • Moderate growth over the next 5 years due to the rarity of the condition (~5% annual growth).
  • Potential price adjustments driven by payer negotiations or biosimilar entry if patent challenges succeed.

Patent and Regulatory Status

• Patent protection extends to at least 2028.
• No biosimilar approvals currently in place; exclusivity maintains pricing power.

Regulatory Considerations

• The FDA approved Cablivi based on the HERCULES trial, showing significant reduction in TTP recurrence (source: FDA [3]).
• No off-label use approvals yet, limiting the market expansion.

Summary

Aspect	Details
Market size (U.S)	~400-600 patients annually
Global market potential	Up to 3,000 patients annually
Current price per treatment	~$210,000–$280,000 per patient based on dosing
Price per vial	~$14,000 (10 mg vial)
Growth rate	Approximately 5% annually for the next 5 years

Key Takeaways

• The treatment is a high-cost biologic with a niche market, primarily used for severe disease.
• Market size is limited by disease prevalence but benefits from high pricing strategies.
• Adoption is near saturation among diagnosed patients, with growth driven by awareness and regulatory developments.
• Payer negotiations and potential biosimilar competition could influence future prices.

FAQs

1. What is the primary indication for NDC 00115-1555?
   Treatment of acquired thrombotic thrombocytopenic purpura (aTTP).

2. What is the typical treatment cost per patient?
   Between $210,000 and $280,000, depending on dosing regimen.

3. Are biosimilars expected soon?
   No current biosimilar approvals; patent protections last until at least 2028.

4. What influences the drug’s market growth?
   Increased diagnosis, clinician awareness, and potential expansion of indications.

5. How does pricing compare to other biologics?
   Similar in high-cost biologics targeting rare diseases, e.g., Soliris.

References

[1] Centers for Disease Control and Prevention (CDC). "Thrombotic Thrombocytopenic Purpura."
[2] SSR Health. "Biologic Pricing Data."
[3] FDA. "Approval Letter for Cablivi."