Last updated: February 21, 2026
What is NDC 83324-0003?
NDC 83324-0003 corresponds to Eptifibatide, marketed as Integrilin. It is an antiplatelet agent used for acute coronary syndromes and percutaneous coronary intervention (PCI). Its primary indication is to prevent thrombotic cardiovascular events.
Market Overview
Size and Growth Drivers
- The global antiplatelet market was valued at approximately USD 9.2 billion in 2022.
- Compound annual growth rate (CAGR) projected at 4.2% through 2028.
- Eptifibatide's market share is influenced by the prevalence of acute coronary syndrome (ACS), PCI procedures, and competition from other antiplatelet drugs.
Key Competitors
- Abciximab (ReoPro): Monoclonal antibody, used for PCI.
- Tirofiban (Aggrastat): Small molecule, mainly for ACS.
- Eptifibatide (Integrilin): Synthetic peptide, often preferred due to administration route and safety profile.
- Plasminogen activators and newer agents potentially impact market share in specific treatment settings.
Market Access
- Predominantly used in hospitals, especially catheterization labs.
- Administration is intravenous, limiting outpatient use.
- Pricing impacts hospital formularies, and reimbursement policies significantly influence sales.
Pricing Landscape
Current Pricing
- Average wholesale price (AWP): Approximately USD 1,200 per 300 mcg vial (per dose).
- Reimbursement rates: vary by payer, with Medicare and Medicaid typically reimbursing lower than AWP.
Price Trends
- Prices for biologics or peptide-based drugs like eptifibatide face downward pressure from biosimilars and generics, though no biosimilar is currently approved for eptifibatide.
- Patent expiry for originator products tends to influence pricing; however, eptifibatide's patent situation remains stable as of 2023.
- Price reductions of 10-20% are observed when multiple suppliers compete and as market penetration deepens.
Future Projections
- Price decline estimates of around 3-5% annually over the next five years due to increased competition and biosimilar development.
- Potential price stabilization if regulatory barriers delay biosimilar entry or if new indications extend the product's patent life.
Regulatory and Policy Impact
- Trials introducing broader indications could sustain or increase demand.
- Federal and state reimbursement policies may affect real-world pricing.
- Countries with nationalized healthcare systems tend to pay less per unit, influencing global pricing.
Market Penetration and Adoption
- Widely adopted in hospital settings for PCI and ACS.
- Usage rates depend on local clinical guidelines and physicians' preferences.
- The rise of alternative, oral antiplatelet agents in some settings poses a threat to growth.
Summary Table of Market Data
| Metric |
Value / Projection |
| 2022 market size |
USD 9.2 billion |
| CAGR (2023–2028) |
4.2% |
| Current price per vial (USD) |
USD 1,200 (approximate) |
| Price decline (2023–2028) |
3–5% per year |
| Market share (estimated) |
Dominated by integrilin, with competition from ReoPro |
| Patent status |
Active as of 2023, no biosimilar approved |
Key Takeaways
- The drug's primary market remains hospital-based PCI and ACS procedures.
- Pricing remains stable but is under pressure from emerging competitors.
- Annual price declines are expected, influenced by market competition and policy changes.
- Growth will depend on clinical guideline adoption and demand for PCI procedures.
- Regulatory developments and potential new indications may influence future market dynamics.
FAQs
1. Will biosimilars enter the market for eptifibatide?
No biosimilar has received approval as of 2023. Patent protections remain active, but biosimilar development might accelerate after patent expiry.
2. How might regulatory changes impact pricing?
Stricter reimbursement policies and cost-containment measures could reduce prices, especially in publicly funded healthcare systems.
3. What factors could increase demand for eptifibatide?
Emergence of new indications, increased PCI procedures, or competitive advantages over alternatives could boost demand.
4. Are there any upcoming patent expiries?
No, as of 2023, patent protections are still in effect for eptifibatide, maintaining its market exclusivity.
5. How does eptifibatide compare to competitors in pricing?
Its price per vial is comparable to other injectable antiplatelets, but market dynamics depend on clinical preference, institutional contracts, and reimbursement.
References
[1] MarketsandMarkets. (2022). Antiplatelet Drugs Market. Retrieved from https://www.marketsandmarkets.com
[2] IQVIA. (2023). Hospital Market Data.
[3] U.S. Food and Drug Administration. (2023). Drug Approvals and Patent Status.
[4] ReportLinker. (2022). Global Cardiology Drugs Market.