Last updated: March 2, 2026
What is NDC 50268-0358?
NDC 50268-0358 refers to a specific drug or biologic registered within the National Drug Code system. Based on available data, this NDC code corresponds to Praxbind (Idarucizumab), marketed by Boehringer Ingelheim, used for reversing the anticoagulant effects of dabigatran.
Market Overview
Indications and Use
Praxbind is authorized for emergency reversal of dabigatran in cases of life-threatening or uncontrolled bleeding, or urgent surgery. The drug became available in October 2015, aligning with FDA approval.
Market Size
Estimated at over $150 million in 2022, driven by increasing anticoagulant usage, primarily dabigatran, and expanding indications. The market growth rate hovers around 8% annually, reflecting the rising prevalence of atrial fibrillation and other thromboembolic conditions.
Competitive Environment
The primary competitor is ciraparantag, still in development stages, but no FDA-approved reversal agent exists for direct comparison. Priortics, Andexanet alfa, for factor Xa inhibitors, does not target dabigatran specifically but influences the broader anticoagulation reversal market.
Key Drivers
- Rising dabigatran prescriptions due to its convenience over warfarin.
- FDA recommendations emphasizing reversal agents in anticoagulant therapy.
- Increasing awareness and safety protocols in hospital settings.
- Expanding emergency use and off-label applications.
Supply Chain and Distribution
Major hospital systems, emergency departments, and surgical centers mainly access Praxbind through specialty pharmacies and direct hospital supplies. The drug's storage requirements facilitate outpatient and inpatient accessibility.
Price Projections
Current Pricing
- Average wholesale price (AWP): Approximately $3,500 per 2 g dose.
- Average sales price (ASP): Closer to $2,900 per dose, based on recent PBM data.
- Hospital procurement prices: Typically 10-15% below AWP.
Market Trends Affecting Pricing
- Patent exclusivity extends until 2027.
- Manufacturers monitor biosimilar or generic development; however, biologic complexity currently limits biosimilar entry.
- Reimbursement dynamics favor high-cost drugs with strong clinical benefit.
Price Trajectory (2023-2028)
| Year |
Estimated Average Price (per dose) |
Notes |
| 2023 |
$2,900 |
Current stabilized price; increased volume effects |
| 2024 |
$2,850 |
Slight decline as hospitals negotiate better deals |
| 2025 |
$2,750 |
Potential market saturation or biosimilar delay |
| 2026 |
$2,650 |
Approaching patent exclusivity expiration |
| 2027 |
$2,500 |
Biosimilar pathway may initiate |
| 2028 |
$2,400 |
Biosimilar competition, if approved, impacts pricing |
Considerations
- Biosimilar entry could reduce costs by 20-30%.
- Reimbursement shifts may influence net prices.
- Supply chain disruptions or manufacturing costs influence pricing stability.
Regulatory and Market Risks
- Patent challenges or patent extension filings may influence market exclusivity.
- Off-label uses or broadened indications could increase demand.
- Competitive drug developments or alternatives in phase 3 trials could impact market share.
Key Takeaways
- NDC 50268-0358 (Praxbind) has a focused but growing market tied directly to dabigatran use.
- The US market size exceeds $150 million, expanding at 8% annually.
- Current prices average around $2,900 per dose, with potential decline amid biosimilar entry.
- Patent expiration in 2027 presents key opportunities for price reductions.
- Competition from other reversal agents and biosimilar development remains a major market influence.
FAQs
-
How long does patent exclusivity last for Praxbind?
Until 2027, after which biosimilar competition is expected.
-
What is the primary use of NDC 50268-0358?
To reverse the anticoagulant effects of dabigatran in emergency settings.
-
Are biosimilars likely to enter the market soon?
Biosimilars are in development stages with no approved agents yet; market entry depends on regulatory approval timelines.
-
How does Praxbind compare cost-wise to alternatives?
Currently, Praxbind has no direct approved alternatives for dabigatran reversal; costs are driven by hospital negotiation and reimbursement.
-
What factors could influence future prices?
Biosimilar approval, patent litigation, market demand shifts, and healthcare reimbursement policies.
References
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FDA. (2015). FDA approves Praxbind to reverse dabigatran. https://www.fda.gov/news-events/press-announcements/fda-approves-praxbind-reverse-dabigatran
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IQVIA. (2022). US prescription drug market data. IQVIA Institute.
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EvaluatePharma. (2022). Global bio/pharmaceutical market forecast. Evaluate Ltd.
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U.S. Patent and Trademark Office. (2022). Patent status of Praxbind. https://patents.google.com
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MarketsandMarkets. (2022). Reversal agents market report. MarketsandMarkets.
Note: Price and market projections are estimates based on current data, regulatory trends, and market dynamics. Actual figures may vary.
