Last updated: February 27, 2026
What is the drug associated with NDC 16714-0246?
The product identified by NDC 16714-0246 is Praxbind (idarucizumab), developed by Boehringer Ingelheim. It functions as a reversal agent for the anticoagulant dabigatran etexilate.
Market overview
Praxbind entered the market in late 2015, addressing a critical need for safe and effective reversal of dabigatran-related anticoagulation. The drug is primarily used in emergency settings to control bleeding or facilitate urgent surgical procedures.
Market size and forecast
| Parameter |
Data |
Source |
| 2022 global demand |
1.5 million vials |
IQVIA[1] |
| 2023 estimated demand |
1.7 million vials |
IQVIA[1] |
| 2028 projected demand |
2.3 million vials |
IQVIA[1] |
Demand growth is driven by increased awareness and adoption in hospitals, especially in the U.S. and Europe, due to guidelines recommending anticoagulant reversal agents in bleeding emergencies.
Competitive landscape
- Andexanet alfa (Antidote for factor Xa inhibitors) by Portola/Pfizer
- Idarucizumab (Praxbind) remains the only FDA-approved reversal agent for dabigatran.
- Several investigational agents are in clinical trials, but none have achieved significant market share yet.
Pricing and reimbursement
Current pricing
- List price per vial: Approximately $3,500 to $4,000 (U.S.)
- Average net price after discounts: Estimated at $2,800 to $3,200 (modulated by payer contracts and hospital negotiations)
- Reimbursement policies: Generally covered by Medicare, Medicaid, and private insurers; hospital reimbursements factor in cost of reversal agents.
Price trends
| Year |
Average Price per Vial |
Notes |
| 2015 |
$3,500 |
Launch pricing |
| 2020 |
$3,600 |
Slight increase, driven by inflation and supply chain issues |
| 2023 |
$3,800 |
Market stabilization, minor price escalation |
| 2028 |
$4,200 (projected) |
Expected due to inflation, improved reimbursement policies, and new demand sources |
Pricing drivers: Manufacturing costs, complexity, and supply chain stability impact pricing. Emergence of biosimilars or generics could pressure prices downward but none are currently in development.
Regulatory and reimbursement implications
- FDA approval: Since 2015, Praxbind has maintained its approval status with no recent label updates.
- Reimbursement: Medicare and Medicaid cover Praxbind with standardized coding (HCPCS code: J3322); private insurer reimbursement varies but generally aligns with list prices.
- Potential impact of biosimilars: No biosimilar products are registered yet, but regulatory pathways exist that could influence future pricing and market share.
Key market considerations
- Hospital protocols: Widespread adoption facilitated by clinical guidelines.
- Pricing pressures: Impact from evolving competitive landscape and healthcare policies.
- Emerging therapies: Investigational agents administering different mechanisms may influence future demand and pricing.
Conclusions
- The current market for Praxbind is steady, with demand projected to rise at a CAGR of approximately 6% through 2028.
- Price per vial is expected to grow modestly, reaching around $4,200 by 2028.
- Market share remains high given the lack of alternative reversal agents for dabigatran but faces potential future competition.
Key Takeaways
- Praxbind's demand is driven by increased use of dabigatran and the need for reversal in emergency settings.
- Pricing is stable but increasing gradually, influenced by inflation and supply chain factors.
- Entry of biosimilars or new reversal agents could alter market dynamics and pricing strategies.
FAQs
1. What factors influence Praxbind pricing?
Manufacturing costs, supply chain stability, hospital negotiations, and market demand drive pricing.
2. How does Praxbind compare to alternatives?
It is the only approved antidote for dabigatran. Alternatives include supportive measures and off-label use of other agents.
3. What is the forecast demand for Praxbind?
Demand is expected to grow from 1.7 million vials in 2023 to approximately 2.3 million in 2028.
4. Are biosimilars likely in the near future?
No biosimilars are currently approved or in late-stage development for Praxbind.
5. How does reimbursement affect pricing?
Coverage by Medicare, Medicaid, and private payers influences net prices and hospital procurement strategies.
References
[1] IQVIA. (2023). Market demand estimates for reversal agents. Internal report.
