Last updated: July 28, 2025
Overview of NDC 00259-0501
NDC 00259-0501 refers to a specific pharmaceutical product registered within the U.S. National Drug Code (NDC) system. This particular code is associated with Eptifibatide Injection, marketed under the brand Integrilin by Merck & Co.
Eptifibatide is an antiplatelet agent used primarily to prevent blood clots during percutaneous coronary interventions (PCI) and for acute coronary syndrome (ACS). Its clinical significance, market dynamics, and manufacturing landscape shape its pricing and competitive positioning.
Manufacturing and Patent Status
As of the latest records, Merck's patent protections for Integrilin expired in 2013, opening pathways for generic manufacturing. The entry of generics has been pivotal in influencing pricing and market share. Several manufacturers now produce biosimilar or generic versions, increasing supply and competitive pressure.
Key Point: Patent expiration has historically contributed to price erosion in this segment, with the market now characterized by multiple suppliers.
Market Size and Demand Dynamics
The demand for Eptifibatide hinges on the prevalence of ACS and PCI procedures. The U.S. alone reports over 1 million PCI procedures annually, with a significant proportion requiring antithrombotic therapy. Globally, the market is expanding in Europe, Asia-Pacific, and emerging markets due to increasing cardiovascular disease (CVD) incidence.
Market Drivers:
- Rising global CVD incidence
- Expanding PCI adoption rates
- Evolving guidelines favoring potent antiplatelet agents
- Healthcare infrastructure developments in Asia-Pacific
Market Constraints:
- Competition from alternative antithrombotic agents (e.g., tirofiban, abciximab)
- Cost considerations and reimbursement policies
- Strict regulatory landscapes affecting biosimilar approvals
Current Pricing Landscape
Historically, the wholesale acquisition cost (WAC) for Eptifibatide injections has hovered between $300 to $600 per vial in the U.S., influenced by dosage, packaging, and supplier competitiveness. Post-patent expiration, the entry of generics has driven prices downward, with recent averages estimated around $250 to $350 per vial, depending on volume and supplier.
Manufacturers & Prices:
| Manufacturer |
Approximate Price (per vial) |
Notes |
| Merck (Brand) |
~$560 |
Premium, branded product |
| Multiple Generics |
~$250–$350 |
Competitive market entry; price erosion |
The price reduction is compounded by purchasing agreements, insurance coverage, and institutional negotiations.
Regional Market Trends and Price Dynamics
- United States: Dominated by generic availability; prices stabilized post-generic entry.
- Europe: Similar trends, with national regulatory agencies negotiating biosimilar uptake leading to discounts.
- Asia-Pacific: Growing demand with increasing hospital procurement; prices remain variable due to differing regulatory standards and manufacturing hubs.
- Emerging Markets: Price sensitivity is high; local production and importation influence final prices.
Future Price Projections
Short-Term (1–2 Years):
- Expect continued stabilization of generic prices around $200–$300 per vial, with minimal fluctuations barring supply chain disruptions.
- Tactical pricing might be influenced by procurement policies in large health systems and insurance negotiations.
Medium to Long-Term (3–5 Years):
- As biosimilar and generic competition intensifies, prices could further decline by 10%–20%, reaching as low as $150–$200 per vial.
- Market consolidation and potential new entrants could reshape cost dynamics, especially if innovative delivery methods or formulations enter the market.
Influencing Factors:
- Regulatory approvals of biosimilars and generics in key markets
- Patent litigations and exclusivity periods
- Advances in therapy alternatives in acute coronary management
- Payer and hospital procurement strategies
Competitive Landscape and Market Share
The entrance of biosimilars has fragmented the market, although Merck’s Integrilin maintains brand loyalty in certain settings. Competitive pricing, supply reliability, and clinical equivalence have driven generic winners' ability to capture significant market share, influencing overall price trends.
Potential Entrants:
- Biosimilar developers focusing on antithrombotic agents
- Regional manufacturers in emerging markets leveraging lower production costs
The market is expected to become increasingly price-competitive, favoring cost-conscious healthcare systems.
Risks and Opportunities
Risks:
- Regulatory hurdles delaying biosimilar approvals
- Reduced demand in favor of newer antiplatelet agents
- Pricing pressures from healthcare payers and policy reforms
Opportunities:
- Increased use in developing markets
- Strategic partnerships for supply chain expansion
- Diversification into combination therapies or alternative formulations
Key Takeaways
- Patent expiration has driven prices downward, with generic versions compelling competition.
- The U.S. market pricing currently hovers around $250–$350 per vial, trending downward.
- Globally, price sensitivity and regulatory factors create regional variability.
- Short-term projections suggest modest annual price reductions, with more significant declines anticipated as biosimilars penetrate further.
- Healthcare systems emphasizing cost-efficiency are likely to favor lower-cost generics, pressuring traditional brand prices.
FAQs
1. How has patent expiration impacted the pricing of NDC 00259-0501?
Patent expiration has facilitated the entry of generic manufacturers, leading to increased competition, supply abundance, and significant price reductions for Eptifibatide.
2. What factors could influence future price trends for Eptifibatide?
Regulatory approvals of biosimilars, shifts in clinical guidelines, new competing agents, and procurement strategies all influence future pricing trajectories.
3. How does the global market for Eptifibatide compare to the U.S.?
The global market exhibits greater variability due to differing regulatory environments, manufacturing bases, and healthcare infrastructure, often resulting in lower prices in emerging economies.
4. Are there alternative therapies affecting the demand and prices of Eptifibatide?
Yes. Newer antiplatelet and antithrombotic agents, such as prasugrel and ticagrelor, may alter demand dynamics and influence pricing strategies.
5. What is the outlook for Eptifibatide with emerging biosimilar products?
Biosimilars are expected to further reduce prices and expand access, especially in price-sensitive markets, but their market penetration depends on regulatory approval timelines and clinical acceptance.
References
- U.S. Food and Drug Administration. Drug Approvals and Labeling. (Accessed 2023).
- IQVIA Institute. Global Use of Medicines in 2022.
- Merck & Co. Integrilin Prescribing Information.
- Healthcare Cost and Utilization Project (HCUP). Cardiovascular Procedures Data.
- AnalyzePharma. Biologic and Biosimilar Market Reports.
