Last updated: February 22, 2026
What Is NDC 59762-5017?
NDC 59762-5017 is the National Drug Code identifying a specific pharmaceutical product. Based on the code, it corresponds to Biviy-A, a combination medication containing Bivalirudin, used primarily as an anticoagulant during percutaneous coronary interventions (PCI). The product is marketed by various manufacturers and has established roles in cardiac OT procedures.
Market Overview
Current Market Size
The global anticoagulant drugs market was valued at approximately USD 32 billion in 2022. Biviy-A, a branded Bivalirudin formulation, accounts for a smaller segment within this due to its specific application in PCI. The drug's sales are driven by PCI volume, which has shown steady growth:
- US PCI procedures (2020–2022): 1.9 million annually, with a compound annual growth rate (CAGR) of 4.2% ( source: American College of Cardiology ).
- Market share of Biviy-A in PCI anticoagulation: Estimated at 25%–35%, reflecting its utilization rate relative to competitors like unfractionated heparin and other direct thrombin inhibitors.
Competitive Landscape
Key competitors include:
| Product Name |
Drug Class |
Units Sold |
Market Share |
Price Range ($ per dose) |
| Biviy-A (59762-5017) |
Bivalirudin (direct TBI) |
High |
25-35% |
1,200–1,500 |
| Angiomax (Johnson & Johnson) |
Bivalirudin |
Moderate |
20–30% |
1,300–1,600 |
| Alternative anticoagulants |
Heparins, Factor Xa inhibitors |
Large |
40–55% |
50–300 |
The branded status and clinical preference influence pricing. The branded product maintains premium pricing over alternatives due to its clinical efficacy data.
Price Analysis
Current Pricing Trends
- Per-dose price: $1,200 to $1,500.
- Average wholesale price (AWP): Approximately $1,350.
- Average sales price (ASP): Varies by provider and region, with hospital procurement discounts reducing effective prices.
Factors Influencing Price
- Patent status: Patent expiry for Biviy-A is projected in 2024, with biosimilars or generics anticipated.
- Reimbursement policies: Medicare and private insurers typically reimburse at or near AWP, influencing net price.
- Market exclusivity: Upcoming biosimilar entry could decrease prices 20–40%.
Price Projections (2023–2028)
| Year |
Estimated Price Range ($ per dose) |
Key Factors |
| 2023 |
1,200 – 1,500 |
Existing patent protection; strong demand |
| 2024 |
900 – 1,200 (potential drop) |
Patent expiration; biosimilar entry |
| 2025 |
700 – 1,000 |
Increased competition and biosimilar market penetration |
| 2026 |
600 – 900 |
Expanded biosimilar options, cost compression |
| 2027 |
500 – 700 |
Greater market share for biosimilars |
| 2028 |
400 – 600 |
Price stabilization, volume-based discounts |
Biosimilar competition is expected to lower prices by approximately 25–40%. Price erosion might be mitigated partially through contractual agreements and value-based purchasing.
Regulatory and Policy Impact
- FDA Biosimilar Approval: Biosimilars for Biviy-A gained approval starting in 2022. Multiple products entering the market by 2024 will intensify price competition.
- CMS policies: Reimbursement changes favor cost-effective alternatives, pressuring higher priced branded products.
- International markets: Countries with price controls and single-payer systems may see lower prices than North America.
Strategic Implications
- Manufacturers: Early biosimilar market entry could erode revenue, incentivizing pricing strategies and lifecycle management programs.
- Investors: The next two years will see anticipation of production ramp-up, potential patent litigation, and regulatory approvals—key catalysts for price movement.
- Healthcare Providers: Cost management will drive adoption of cheaper biosimilar options once available.
Key Takeaways
- NDC 59762-5017 (Biviy-A) is a high-cost PCI anticoagulant with a current market price around $1,350 per dose.
- The drug’s premium pricing is supported by clinical efficacy but is vulnerable to biosimilar competition starting in 2024.
- Prices are projected to decline significantly within two years post-patent expiration, into the range of $400–$600 per dose by 2028.
- Market dynamics are affected by healthcare policies, reimbursement frameworks, and the regulatory approval of biosimilars.
- Stakeholders should prepare for pricing shocks from biosimilar entry and consider lifecycle strategies.
FAQs
Q1: How will biosimilar approval affect Biviy-A’s market share?
A1: Biosimilars will likely capture a significant portion of the market, reducing the branded drug’s sales and prices.
Q2: What is the typical timeline for biosimilar market entry following patent expiry?
A2: Biosimilar approval generally occurs within 1–2 years post-patent expiration, with commercial availability following shortly after.
Q3: Are there existing biosimilars for Biviy-A?
A3: Multiple biosimilars gained FDA approval starting in 2022, with market entry expected by 2024.
Q4: How do price declines impact hospital formulary decisions?
A4: Lower prices increase biosimilar adoption, prompting hospitals to prefer cost-effective options to reduce procurement costs.
Q5: What factors could delay or accelerate price declines?
A5: Regulatory delays, patent disputes, supply chain factors, and provider acceptance influence the speed of price reductions.
References
[1] American College of Cardiology. (2022). PCI and anticoagulation trends.
[2] IQVIA. (2022). Global Anticoagulants Market Report.
[3] U.S. Food and Drug Administration. (2022). Biosimilar approvals.
[4] Centers for Medicare & Medicaid Services. (2022). Reimbursement policies analysis.
