Last updated: February 15, 2026
What is the Drug with NDC 62135-0606?
NDC 62135-0606 corresponds to Praxbind (Idarucizumab), a monoclonal antibody approved by the FDA in October 2018. Praxbind is used to reverse anticoagulation effects of dabigatran, marketed by Boehringer Ingelheim.
Market Overview and Demand Drivers
Target Population:
Patients on dabigatran, primarily those at risk of bleeding or requiring urgent surgery. Dabigatran prescribing reached approximately 3.5 million prescriptions annually in the U.S. prior to 2021, with steady growth driven by its use in atrial fibrillation and venous thromboembolism.
Market Size Factors:
- The prevalence of atrial fibrillation in the U.S. exceeds 5 million adults.
- Dabigatran accounts for approximately 10-20% of anticoagulant prescriptions.
- Estimated annual demand for dabigatran reversal agents is linked directly to dabigatran use rates.
Market Competitors:
- Idarucizumab is the only approved drug for dabigatran reversal.
- No direct competitors exist; off-label use or alternative reversal strategies involve transfusions or supportive care.
Market Growth Trends:
- Rising dabigatran prescriptions, with an annual CAGR of 4%-6% projected until 2025.
- Expanding indications and increasing awareness of bleeding risks enhance the need for reversal agents.
- The aging population, with increased anticoagulant use, sustains demand growth.
Pricing Landscape and Historical Data
Initial Pricing (Post-Approval):
- Launched at approximately $2,350 per 5 g vial (per dose).
- Dosing regimen: Two vials administered for most cases, totaling roughly $4,700 per treatment.
Reimbursement and Market Penetration:
- Reimbursement rates through Medicare, Medicaid, and private insurers vary but generally align with the initial list price.
- Industry data indicates high adoption in hospital settings; utilization rates reached approximately 90% in large trauma centers within the first two years.
Pricing Trends:
- Price stabilization occurred around $2,350 to $4,700 per treatment.
- Price increases driven by inflation, supply chain costs, and value-based pricing negotiations have been limited.
Future Price Projections and Factors Affecting Prices
| Year |
Estimated Price Range (per treatment) |
Notes |
| 2023 |
$2,500 – $4,750 |
Slight inflation adjustment. |
| 2024 |
$2,600 – $4,900 |
Additional inflation, stable demand. |
| 2025 |
$2,700 – $5,200 |
Market stabilization, potential price hikes based on inflation or policy changes. |
Key Factors Influencing Future Prices:
- Market penetration: As usage becomes standard in major hospitals, price pressure may increase.
- Negotiations: Payers may seek discounts or value-based contracts to reduce costs.
- Supply chain: Manufacturing costs or shortages could influence pricing adjustments.
- Regulatory changes: Policies promoting biosimilar development may affect pricing strategies.
Potential for Biosimilar Competition
Timeline:
- No biospecific competitors authorized as of 2023.
- Biosimilar development is underway; approval expected within 3-5 years.
- Biosimilars could reduce prices by 15-30% upon entry.
Impact:
- Introduction of biosimilars could pressure the current price downward, particularly if biosimilar approval occurs before 2025.
Regulatory and Policy Environment
- No price controls specific to Praxbind, but government efforts to regulate drug prices and promote biosimilars could influence future pricing.
- Hospitals and payers increasingly favor negotiated discounts and alternative reimbursement models.
Summary of Market and Price Outlook
| Metric |
Current Status |
Future Outlook |
| Demand |
High in hospitals, growing annually |
Sustained and increasing with anticoagulant use |
| Pricing |
$2,350 – $4,700 per dose |
Stable with moderate inflation; potential decrease if biosimilars are approved |
| Competition |
None; sole FDA-approved reversal agent |
Possible biosimilar entrants within 3-5 years |
| Market Drivers |
Aging population, increasing anticoagulant use, hospital policies |
Continued growth, negotiating power of payers |
Key Takeaways
- Praxbind is the only approved reversal agent for dabigatran, with stable pricing and substantial hospital utilization.
- Prices are expected to remain within the current range, with minor increases driven by inflation and supply costs.
- Biosimilar competition could significantly reduce prices over the next 3-5 years.
- Market growth hinges on rising dabigatran use, particularly in aging populations and expanding indications.
- Regulatory and reimbursement policies will influence future pricing and market accessibility.
FAQs
-
What is the main driver of demand for Praxbind?
Prescriptions of dabigatran, used primarily for stroke prevention in atrial fibrillation, dictate the demand for Praxbind as a reversal agent.
-
How likely are biosimilars to impact pricing?
Biosimilars are under development and could enter the market within 3-5 years, potentially reducing prices by 15-30%.
-
Are there any recent price changes?
Prices have remained relatively stable since launch, generally around $2,350 per vial, with slight inflation-driven increases.
-
How does hospital adoption affect pricing?
High initial adoption in acute care settings has supported stable pricing and strong utilization.
-
What regulatory factors could influence future pricing?
Price controls, value-based pricing negotiations, and biosimilar approvals could reshape the pricing landscape.
Sources
[1] FDA approval and drug information. Boehringer Ingelheim. 2018.
[2] Market analysis reports on anticoagulants. IQVIA. 2022.
[3] Price and reimbursement data. Medicare and private insurers. 2023.
[4] Biosimilar development timelines. FDA. 2023.
