Last updated: February 20, 2026
What is NDC 35573-0455?
NDC 35573-0455 corresponds to Praxbind (idarucizumab), a monoclonal antibody fragment authorized by the FDA in October 2015. It is used as a reversal agent for the anticoagulant dabigatran (Pradaxa) in cases of uncontrolled bleeding or emergency surgery.
Market Overview
Market Size and Growth
Praxbind's primary market is hospitals and emergency departments treating bleeding complications related to dabigatran.
- US Market: Estimated at approximately 1 million dabigatran prescriptions annually as of 2022 (IQVIA).
- Reversal Agent Utilization Rate:
- Estimated at 2-5% of dabigatran patients per year.
- Potentially 20,000-50,000 doses used annually.
- Market Value:
- Current average wholesale price (AWP): approximately $4,500 per dose.
- Annual sales estimate: between $90 million and $225 million.
Competitive Landscape
- Idarucizumab (Praxbind) is the only FDA-approved reversal agent for dabigatran.
- No direct biosimilar competitors currently on the US market.
- Off-label or experimental reversal agents are under development but lack regulatory approval.
Regulatory Environment
- FDA approved in 2015.
- Pending or potential future approvals for similar agents or biosimilars are not imminent.
- Reimbursement policies:
- Usually covered under hospital outpatient or inpatient billing.
- No specific charge restriction, facilitating uptake.
Price Trajectory Projections
Historical Pricing Trends
- Initial launch price (2015): ~$3,500 per dose.
- Post-approval adjustment: Increased to about $4,500 by 2018, reflecting market acceptance and inflation.
Short-Term (Next 1-2 Years)
- Due to increased hospital procurement and stable demand, prices are expected to remain around $4,500.
- No significant price drops anticipated as competition is limited.
Medium to Long-Term (3-5 Years)
- Potential introduction of biosimilars could pressure prices downward.
- Price reductions of 10-15% over five years are feasible if biosimilar approval occurs.
- Alternatively, increased usage or expanded indications could uphold stable or slightly rising prices.
Key Factors Influencing Price Dynamics
| Factor |
Impact |
| Biosimilar Entry |
Potential 10-15% price decrease over 5 years |
| Hospital Procurement Policies |
Volume-driven discounts could moderate unit price |
| Reimbursement Changes |
Policies encouraging utilization could stabilize prices |
| International markets (non-US) |
Lower prices due to different healthcare systems |
Future Market Drivers
- Increased awareness of anticoagulation reversal options.
- Emergence of new anticoagulants with different reversal agents.
- Hospital budgets and procurement strategies.
- Regulatory changes affecting biosimilar approval and competition.
Key Takeaways
- The current US market for NDC 35573-0455 (Praxbind) is estimated at $90-$225 million annually.
- Price has stabilized at around $4,500 per dose since 2018.
- Limited near-term pricing pressure expected without biosimilar competition.
- Over 5 years, prices may decline by approximately 10-15% if biosimilar options are introduced.
- Market growth depends on higher uptake and potential new indications or formulations.
FAQs
1. How does Praxbind compare in price to other reversal agents?
Praxbind's price (~$4,500) is significantly higher than traditional vitamin K–based reversal agents for warfarin but is justified by its specificity and rapid action in dabigatran reversal.
2. What is the potential impact of biosimilar entry?
Biosimilar introduction could lead to a 10-15% reduction in prices over five years, driven by competitive pressure. However, as of early 2023, no biosimilars are FDA-approved for idarucizumab.
3. Are there any regulatory barriers to biosimilar development for Pradaxa reversal?
Yes. Biosindividuals require demonstrating similarity to the originator drug with comparable efficacy and safety, necessitating significant clinical trials, which may slow entry.
4. How important is hospital procurement volume in price trends?
High procurement volumes can lead to volume-based discounts, but the wholesale and reimbursement prices remain stable unless competition or policy changes significantly alter the market.
5. Are there new therapies or drugs that might displace Praxbind?
Current alternatives are limited. Fully oral or long-acting reversal agents are under developmental investigation but are not yet available commercially.
References
[1] IQVIA. (2022). Dabigatran prescription data. Retrieved from IQVIA database.
[2] FDA. (2015). Praxbind (idarucizumab) approval notice. Retrieved from FDA website.
[3] MarketWatch. (2022). Pharmaceutical pricing trends. Retrieved from MarketWatch.com.
[4] Evaluate Pharma. (2022). Biosimilar pipeline and market forecasts. Retrieved from Evaluate.com.
