Suppliers and packagers for EPTIFIBATIDE

EPTIFIBATIDE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare Corp	EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	208554	ANDA	Baxter Healthcare Company	0338-9558-10	1 VIAL, SINGLE-DOSE in 1 CARTON (0338-9558-10) / 100 mL in 1 VIAL, SINGLE-DOSE	2019-02-01
Eugia Pharma	EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	206127	ANDA	Eugia US LLC	55150-218-99	1 VIAL, SINGLE-DOSE in 1 CARTON (55150-218-99) / 100 mL in 1 VIAL, SINGLE-DOSE	2015-12-08
Eugia Pharma	EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	206127	ANDA	Eugia US LLC	55150-219-10	1 VIAL, SINGLE-DOSE in 1 CARTON (55150-219-10) / 10 mL in 1 VIAL, SINGLE-DOSE	2015-12-08

Eptifibatide Supplier Landscape: Key Manufacturers and Patent Expirations

Last updated: February 19, 2026

This analysis details the critical suppliers of Eptifibatide, a glycoprotein IIb/IIIa inhibitor used in treating acute coronary syndromes. It examines key manufacturers, their manufacturing capabilities, and relevant patent expiration dates to inform R&D and investment strategies.

Who are the Primary Manufacturers of Eptifibatide Active Pharmaceutical Ingredient (API)?

The global supply chain for Eptifibatide API is concentrated among a limited number of specialized manufacturers. These entities possess the complex synthetic capabilities and regulatory compliance required for pharmaceutical-grade production.

• Merck & Co. The originator of Eptifibatide (marketed as Integrilin), Merck was historically the primary manufacturer. Post-patent expiration, their role has shifted towards lifecycle management and potentially contract manufacturing, though direct API supply to the broader market may be limited.
• Nanjing Pharmaceutical Valley Bio-Tech Co., Ltd. This Chinese company is a significant player in the Eptifibatide API market. They offer the API for both branded and generic pharmaceutical companies.
• BioSyntan AG. A German-based manufacturer, BioSyntan AG also supplies Eptifibatide API. Their focus is on high-quality API production for the global pharmaceutical industry.
• Others. Several smaller contract manufacturing organizations (CMOs) and specialized chemical synthesis companies globally may produce Eptifibatide API on a smaller scale or for specific regional markets. These can include entities in India and Eastern Europe, often operating under specific client contracts.

Table 1 outlines key Eptifibatide API suppliers and their general market positioning:

Supplier Name	Country of Origin	Primary Offering	Regulatory Approvals (Indicative)	Notes
Merck & Co.	United States	Originator, Branded Product	FDA, EMA	Historical sole supplier; current API supply dynamics require direct inquiry.
Nanjing Pharmaceutical Valley Bio-Tech Co., Ltd.	China	Eptifibatide API	DMF filings, potential GMP certs	Significant supplier to generic manufacturers.
BioSyntan AG	Germany	Eptifibatide API	EU GMP, potential DMF filings	Focus on high-purity API for regulated markets.
Various CMOs/Specialty Chemical Firms	Global	Eptifibatide API (contract)	Variable	Production is often project-specific, requiring rigorous quality and IP due diligence.

What is the Patent Landscape for Eptifibatide and its Key Intermediates?

The patent landscape for Eptifibatide is characterized by the expiration of its primary composition of matter and method of use patents, paving the way for generic competition.

The foundational patent covering Eptifibatide itself, U.S. Patent No. 4,884,983, was granted on December 5, 1989. This patent expired in December 2006. This expiration is a critical factor enabling the market entry of generic Eptifibatide products.

Beyond the core compound patent, other patents may have covered specific manufacturing processes, polymorphic forms, or formulations. However, these are generally considered secondary to the composition of matter patent in defining market exclusivity.

• U.S. Patent No. 4,884,983: Composition of matter for Eptifibatide. Expiration: December 2006.
• Related Process Patents: While specific numbers are not detailed here, patents related to the synthesis of Eptifibatide and its key intermediates would have also had expiration dates. The specific routes and intermediates used by different manufacturers can be subject to their own process patents. Given the age of the core patent, many early process patents would have also expired.

The absence of robust, long-term patent protection for Eptifibatide means that market dynamics are primarily driven by manufacturing efficiency, regulatory compliance, and commercialization strategies for generic versions.

What are the Regulatory Considerations for Eptifibatide API Manufacturing?

Manufacturing Eptifibatide API requires adherence to stringent global regulatory standards to ensure product quality, safety, and efficacy.

• Good Manufacturing Practices (GMP): All API manufacturers must comply with GMP regulations as defined by major regulatory bodies like the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others. This includes rigorous control over facilities, equipment, personnel, raw materials, production processes, and quality control.
• Drug Master Files (DMFs): Manufacturers typically file DMFs with regulatory agencies (e.g., FDA). A DMF contains confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. This allows drug product manufacturers to reference the DMF in their marketing applications without needing direct access to the proprietary information.
• Quality Control and Testing: Comprehensive testing of the API is mandatory. This includes assays for purity, potency, identity, and the absence of impurities, including residual solvents, heavy metals, and related substances. Specific analytical methods validated according to ICH guidelines are employed.
• Impurity Profiling: A critical aspect of API manufacturing is understanding and controlling impurities, particularly genotoxic impurities. For peptide-based drugs like Eptifibatide, this involves close attention to amino acid purity, potential side-chain modifications, and degradation products.
• Supply Chain Security: Manufacturers must demonstrate robust control over their supply chain, including sourcing of raw materials and intermediates, to prevent counterfeiting and ensure consistent quality.

What is the Market Status and Outlook for Eptifibatide?

The market for Eptifibatide is now predominantly a generic market following the expiration of its primary patents.

• Generic Competition: With patent expiry, multiple generic manufacturers have entered or can enter the market, leading to price erosion and increased competition. This typically results in lower prices for the finished drug product, making it more accessible.
• Demand Drivers: The demand for Eptifibatide is tied to the incidence of acute coronary syndromes (ACS), including unstable angina and non-ST-elevation myocardial infarction, where it is used as an adjunct therapy. While newer anticoagulants and antiplatelet agents exist, Eptifibatide retains a place in certain clinical protocols.
• Manufacturing Costs: The cost-effectiveness of API production is a key competitive differentiator for generic suppliers. Efficient synthesis routes and economies of scale are crucial.
• Regional Variations: Market penetration and pricing can vary significantly by region due to different regulatory approval processes, healthcare systems, and competitive landscapes.
• Future Outlook: The market is expected to remain competitive. Innovation will likely focus on formulation improvements or combination therapies rather than new Eptifibatide patents. Suppliers who can consistently provide high-quality API at competitive prices, backed by strong regulatory compliance, will be best positioned.

What are the Key Considerations for Sourcing Eptifibatide API?

Pharmaceutical companies seeking to source Eptifibatide API must undertake a thorough due diligence process.

• Supplier Qualification: This involves assessing the supplier's GMP compliance, regulatory track record, capacity, and financial stability. Site audits are essential.
• Quality Agreements: Establishing detailed quality agreements is critical to define responsibilities for quality control, change management, and deviation handling.
• Regulatory Support: Suppliers must provide comprehensive regulatory documentation, including access to DMFs and support for the drug product manufacturer's regulatory filings.
• Supply Chain Reliability: Ensuring a robust and reliable supply chain is paramount to avoid drug shortages. This may involve qualifying multiple suppliers.
• Intellectual Property (IP) Review: While the primary composition of matter patent has expired, potential risks related to process patents or specific manufacturing methods used by a supplier should be evaluated.
• Cost and Lead Times: Negotiating competitive pricing and understanding production lead times are essential for effective inventory management and commercial planning.

Key Takeaways

• Eptifibatide API supply is dominated by a few key manufacturers, with Merck as the originator and Nanjing Pharmaceutical Valley Bio-Tech Co., Ltd. and BioSyntan AG as significant current suppliers.
• The foundational composition of matter patent for Eptifibatide expired in December 2006, enabling generic market entry.
• API manufacturing requires strict adherence to GMP and robust regulatory documentation, including DMFs.
• The Eptifibatide market is mature and largely generic, characterized by price competition and a focus on manufacturing efficiency and reliability.
• Sourcing Eptifibatide API necessitates thorough supplier qualification, quality agreements, and comprehensive regulatory and IP due diligence.

Frequently Asked Questions

1. Are there any active patents blocking the generic production of Eptifibatide API? The primary composition of matter patent expired in 2006. While secondary patents for specific processes or formulations may exist, they generally do not prevent the synthesis and sale of the Eptifibatide molecule itself if those specific patented methods are avoided.

2. What is the typical purity standard for Eptifibatide API from qualified suppliers? API from qualified suppliers typically meets stringent purity requirements, often exceeding 98% or 99%, as per pharmacopoeial standards (e.g., USP, EP) and ICH guidelines, with specific limits on individual impurities and residual solvents.

3. How does the manufacturing complexity of Eptifibatide compare to small molecule drugs? Eptifibatide is a synthetic cyclic heptapeptide. Its synthesis involves multiple peptide coupling steps, cyclization, and purification, which is generally more complex and resource-intensive than the synthesis of many small molecule drugs.

4. Can Eptifibatide API be manufactured using different synthetic routes? Yes, multiple synthetic routes can be employed to produce Eptifibatide. Generic manufacturers often develop or license alternative routes to avoid existing process patents and optimize for cost and yield.

5. What regulatory approvals are necessary for a drug product containing Eptifibatide to be marketed in the U.S. and Europe? In the U.S., a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) for a generic version is required, referencing the API's DMF. In Europe, a Marketing Authorisation Application (MAA) is needed, also referencing the API's details. Both require demonstration of bioequivalence.

Citations

[1] U.S. Patent No. 4,884,983. (1989). Peptide derivatives. Retrieved from USPTO.