Last updated: March 2, 2026
What is NDC 52427-0273?
NDC 52427-0273 is a specific National Drug Code representing a medication listed under the outpatient retail prescription drug market. Based on available databases, this NDC corresponds to Praxbind (idarucizumab) 5 g. Praxbind is an FDA-approved antagonist used to reverse the anticoagulant effects of dabigatran (Pradaxa).
Market Size and Current Adoption
Product Overview
- Indication: Reversal of dabigatran in patients with uncontrolled or life-threatening bleeding or before emergency surgery.
- Approval Date: October 2015.
- Pack Size: 5 g (single-dose vial).
- Price (2023): List price generally ranges from $4,600 to $5,000 per vial, depending on the acquisition channel.
Market Penetration
- Praxbind entered the market during a period of increased dabigatran usage, driven by awareness of direct oral anticoagulants (DOACs).
- As of 2022, estimated annual sales volume is approximately 25,000 to 30,000 units in the U.S.
- Its primary consumers are hospitals and emergency departments, with limited outpatient use.
Competitive Landscape
- No direct antidotes for other DOACs (e.g., rivaroxaban, apixaban).
- Idarucizumab holds a near-monopoly in its class for dabigatran reversal.
- Alternative strategies include supportive care, but these are less effective than specific reversal agents.
Price Trends and Projections
Past and Current Pricing
- List price in late 2010s: approximately $3,500 per vial.
- Increase by 2020: prices rose to around $4,700.
- In 2023, actual transaction prices are approximately $4,600-$5,000 due to factors such as market demand, insurance negotiations, and supply chain considerations.
Factors Influencing Price Changes
- Limited competition post-FDA approval.
- High R&D costs absorbed earlier in development, leading to pricing power.
- Payer negotiations, discounts, and rebates impact net prices.
- Introduction of biosimilars or alternative antidotes could influence future pricing but have not materialized.
Future Price Projections (2024–2028)
| Year |
Estimated Price Range |
Key Assumptions |
| 2024 |
$4,600 – $5,200 |
Continued market stability; no new competitors. |
| 2025 |
$4,600 – $5,300 |
Slight inflation and ongoing demand. |
| 2026 |
$4,700 – $5,400 |
Possible introduction of discount programs. |
| 2027 |
$4,700 – $5,500 |
Market stabilization; potential pressure from biosimilars. |
| 2028 |
$4,800 – $5,600 |
Slight upward drift consistent with healthcare inflation. |
External Influences
- Policy changes encouraging biosimilars could pressure pricing margins.
- Supply chain disruptions or raw material costs could elevate prices.
- Increasing usage of dabigatran could sustain or raise demand.
Market Opportunities and Risks
Opportunities
- Growing awareness and adoption in hospital settings.
- Expansion into outpatient settings if protocols shift.
- Potential for additional indications related to anticoagulant reversal.
Risks
- Emergence of competing antidotes, e.g., Andexanet alfa for factor Xa inhibitors.
- Cost-containment policies by payers.
- Market saturation limiting growth.
Key Takeaways
- NDC 52427-0273 (Praxbind) remains the dominant agent for dabigatran reversal in the U.S.
- Market size is capped by limited indications and adoption mainly in hospitals.
- Current list prices hover around $4,600-$5,000 per vial.
- Future pricing will likely stabilize with modest increases, barring competitive threats or policy shifts.
- Significant sales growth is unlikely without new indications or broader adoption.
FAQs
1. What factors most influence Praxbind’s pricing?
Market exclusivity, limited competition, and high R&D costs contribute primarily to its price. Payer negotiations and rebates also impact net prices.
2. How does product adoption impact future revenue?
Increased hospital use for dabigatran reversal can grow revenues, but outpatient or broader use remains limited unless indications expand.
3. Are biosimilars expected to enter this market?
Biosimilars are unlikely because Praxbind is a monoclonal antibody fragment. However, alternative reversal agents for other anticoagulants could affect its market share.
4. What is the outlook for new indications?
Current approvals are specific to dabigatran reversal. Expanding indications would require clinical trials and regulatory approval, creating potential revenue opportunities.
5. How do policy shifts affect pricing outlooks?
Price controls or biosimilar policies could limit price increases or prompt downward adjustments as payers seek cost savings.
References
- U.S. Food and Drug Administration. (2015). FDA approves Praxbind to reverse effects of Pradaxa. [FDA Release]
- IQVIA. (2022). U.S. Prescription Market Data.
- CMS. (2023). Drug prices and reimbursement policies.
- MarketWatch. (2023). Current pricing trends for idarucizumab.
- EvaluatePharma. (2023). Biologics market analysis.
Note: Exact prices and sales data are estimates based on industry reports and market trends as of early 2023. Future projections are subject to change based on market dynamics and regulatory developments.
