Eptifibatide - Generic Drug Details

What are the generic drug sources for eptifibatide and what is the scope of patent protection?

Eptifibatide is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Amneal Pharms, Baxter Hlthcare Corp, Eugia Pharma, Hybio, Meitheal, Mylan Labs Ltd, Rising, Sagent Pharms Inc, Shuangcheng, Slate Run Pharma, Teva Pharms Usa, USV, and Msd Sub Merck, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for eptifibatide. Eight suppliers are listed for this compound.

Summary for eptifibatide

US Patents:	0
Tradenames:	2
Applicants:	14
NDAs:	16
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	38
Patent Applications:	6,313
Drug Prices:	Drug price trends for eptifibatide
What excipients (inactive ingredients) are in eptifibatide?	eptifibatide excipients list
DailyMed Link:	eptifibatide at DailyMed

See drug prices for eptifibatide

Recent Clinical Trials for eptifibatide

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Xinqiao Hospital of Chongqing	PHASE3
The First Affiliated Hospital of Nanchang University	PHASE3
The First Affiliated Hospital of Hainan Medical College	PHASE3

See all eptifibatide clinical trials

Pharmacology for eptifibatide

Drug Class	Platelet Aggregation Inhibitor
Physiological Effect	Decreased Platelet Aggregation

Anatomical Therapeutic Chemical (ATC) Classes for eptifibatide

B01AC	Platelet aggregation inhibitors excl. heparin
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for EPTIFIBATIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INTEGRILIN	Injection	eptifibatide	2 mg/mL, 100 mL vial	020718	1	2008-12-18
INTEGRILIN	Injection	eptifibatide	2 mg/mL, 10 mL vial	020718	1	2008-09-30

US Patents and Regulatory Information for eptifibatide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Slate Run Pharma	EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	209864-001	Jan 25, 2019	AP	RX	No	No
Sagent Pharms Inc	EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	204693-001	Mar 7, 2018	AP	RX	No	No
Eugia Pharma	EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	206127-002	Dec 8, 2015	AP	RX	No	No
Accord Hlthcare	EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	205557-001	Nov 6, 2017		DISCN	No	No
Usv	EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	204361-002	Mar 14, 2019		DISCN	No	No
Mylan Labs Ltd	EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	203258-001	Jul 20, 2018	AP	RX	No	Yes

Expired US Patents for eptifibatide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-001	May 18, 1998
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-002	May 18, 1998
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-002	May 18, 1998
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-002	May 18, 1998
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-002	May 18, 1998
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-001	May 18, 1998

EU/EMA Drug Approvals for eptifibatide

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Accord Healthcare S.L.U.	Eptifibatide Accord	eptifibatide	EMEA/H/C/004104Eptifibatide Accord is intended for use with acetylsalicylic acid and unfractionated heparin.Eptifibatide Accord is indicated for the prevention of early myocardial infarction in adults presenting with unstable angina or non-Q-wave myocardial infarction, with the last episode of chest pain occurring within 24 hours and with electrocardiogram (ECG) changes and/or elevated cardiac enzymes.Patients most likely to benefit from Eptifibatide Accord treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early PTCA (Percutaneous Transluminal Coronary Angioplasty).	Authorised	yes	no	no	2016-01-11
GlaxoSmithKline (Ireland) Limited	Integrilin	eptifibatide	EMEA/H/C/000230Integrilin is intended for use with acetylsalicylic acid and unfractionated heparin.Integrilin is indicated for the prevention of early myocardial infarction in patients presenting with unstable angina or non-Q-wave myocardial infarction with the last episode of chest pain occurring within 24 hours and with ECG changes and / or elevated cardiac enzymes.Patients most likely to benefit from Integrilin treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early percutaneous transluminal coronary angioplasty (PTCA).	Authorised	no	no	no	1999-07-01

Eptifibatide: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Eptifibatide, a small molecule glycoprotein IIb/IIIa inhibitor, has experienced a significant shift in its market landscape due to patent expiries and the subsequent entry of generic alternatives. Originally developed by Millennium Pharmaceuticals and Schering-Plough (now part of Merck & Co.), its primary indication is for the treatment of acute coronary syndromes (ACS), particularly in patients undergoing percutaneous coronary intervention (PCI). The drug's efficacy in reducing ischemic events has been well-established, but its market exclusivity has diminished, leading to price erosion and a changed competitive environment.

What are the key patents governing Eptifibatide?

The foundational patents for Eptifibatide have expired, allowing for generic competition. The primary composition of matter patent, U.S. Patent No. 4,946,775, which claimed the molecule itself, expired in 2007. Subsequent patents covering specific formulations or methods of use have also largely expired or been successfully challenged. For example, U.S. Patent No. 5,945,407, which claimed a specific method of treating unstable angina and preventing myocardial infarction, faced litigation and was ultimately not extended beyond its initial term. The expiration of these patents has been the primary driver for the entry of generic eptifibatide products.

How has patent expiry impacted Eptifibatide's market exclusivity and pricing?

The expiry of key patents has fundamentally altered Eptifibatide's market exclusivity. Following patent expiration, generic manufacturers were able to enter the market. This has led to a substantial decrease in the drug's price. Prior to generic entry, Integrilin (the brand-name eptifibatide) held market exclusivity, allowing for premium pricing. Post-exclusivity, the price of eptifibatide has fallen by as much as 80-90% in many markets due to competition. This price erosion directly impacts the revenue generated by the originator and creates a more competitive landscape for all market participants.

Who are the major generic competitors in the Eptifibatide market?

The entry of generic manufacturers has fragmented the market. Key players who have launched or are seeking to launch generic eptifibatide include:

• Teva Pharmaceuticals: A major generic drug manufacturer with a broad portfolio.
• Dr. Reddy's Laboratories: An Indian multinational pharmaceutical company that has been active in launching generics for cardiovascular drugs.
• Mylan N.V. (now Viatris): Another significant global generic and specialty pharmaceutical company.
• Sun Pharmaceutical Industries: An Indian multinational pharmaceutical company that is a major player in the global generics market.
• Fresenius Kabi: A German healthcare company that offers a range of generic injectable drugs.

These companies leverage their manufacturing scale and established distribution networks to offer eptifibatide at competitive price points.

What is the current market size and projected growth trajectory for Eptifibatide?

The market size for eptifibatide has significantly contracted in terms of value due to price competition. However, volume may have remained stable or even increased due to the accessibility of lower-cost generic options. Precise current market value figures are proprietary and fluctuate, but industry reports indicate a market value in the hundreds of millions of dollars globally for branded and generic eptifibatide combined, down from its peak when branded exclusivity was in place.

Projected growth is largely dependent on the continued demand for ACS treatments and the pricing dynamics among generic competitors. The overall market for antiplatelet therapies remains robust due to the prevalence of cardiovascular disease. However, the growth trajectory for eptifibatide as a specific product category is likely to be slow, characterized by incremental volume gains offset by ongoing price pressures. Emerging markets may offer some growth potential as healthcare access expands.

What are the key therapeutic indications and patient populations for Eptifibatide?

Eptifibatide is indicated for the treatment of patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI) undergoing an early invasive strategy, and as an adjunct to percutaneous coronary intervention (PCI), including those with ST-elevation myocardial infarction (STEMI) or undergoing elective PCI.

The primary patient populations include:

• Adult patients presenting with acute coronary syndromes (ACS), characterized by chest pain at rest or with minimal exertion, along with electrocardiographic (ECG) changes suggestive of ischemia.
• Patients undergoing PCI, where eptifibatide helps to prevent thrombotic cardiovascular events such as myocardial infarction.

The drug's mechanism of action, inhibiting the final common pathway of platelet aggregation, makes it a critical intervention in acute thrombotic events.

How does Eptifibatide compare to other antiplatelet agents in the ACS and PCI landscape?

Eptifibatide belongs to the class of glycoprotein IIb/IIIa inhibitors. It competes with other agents in this class and with other antiplatelet therapies used in ACS and PCI.

• Other GP IIb/IIIa Inhibitors:

  • Abciximab (ReoPro): A monoclonal antibody fragment. Historically, abciximab had a longer duration of action but was associated with higher rates of bleeding and was more expensive. It is also subject to patent expiries.
  • Tirofiban (Aggrastat): A small molecule inhibitor, similar to eptifibatide. Tirofiban and eptifibatide have comparable efficacy and safety profiles, leading to direct competition in the generic market. Pricing and availability often dictate preference.

• Dual Antiplatelet Therapy (DAPT) with P2Y12 Inhibitors:

  • Clopidogrel (Plavix) and its generics: A thienopyridine P2Y12 inhibitor. Often used in combination with aspirin (aspirin-clopidogrel regimen).
  • Prasugrel (Effient): A more potent P2Y12 inhibitor, generally reserved for patients at higher risk undergoing PCI.
  • Ticagrelor (Brilinta): Another potent P2Y12 inhibitor with a reversible binding mechanism.

While GP IIb/IIIa inhibitors like eptifibatide are potent and fast-acting, their use has become more selective. Guidelines now emphasize P2Y12 inhibitors as the cornerstone of antiplatelet therapy for most ACS patients, with GP IIb/IIIa inhibitors reserved for specific high-risk scenarios (e.g., high thrombus burden, failed PCI, bridging therapy) or in combination with aspirin and a P2Y12 inhibitor. The advent of more effective P2Y12 inhibitors with oral administration and favorable cost-effectiveness has also influenced the market share of injectable GP IIb/IIIa inhibitors.

What is the regulatory status and approval history of Eptifibatide globally?

Eptifibatide was first approved by the U.S. Food and Drug Administration (FDA) in 1998 for unstable angina and NSTEMI. It later received approval for use in patients undergoing PCI.

• U.S. FDA: Approved for ACS and PCI. Generic versions are now available.
• European Medicines Agency (EMA): Approved under the brand name Integrilin. Generic approvals have followed in European Union member states.
• Other Jurisdictions: Eptifibatide is approved in many other countries, including Canada, Australia, and Japan, with similar patterns of branded and generic market development.

The regulatory pathway for generic eptifibatide involved demonstrating bioequivalence to the branded product, a standard requirement for generic drug approval.

What are the manufacturing and supply chain considerations for Eptifibatide?

The manufacturing of eptifibatide involves peptide synthesis, a complex biochemical process requiring specialized facilities and expertise. The supply chain for both branded and generic eptifibatide includes:

• Active Pharmaceutical Ingredient (API) Manufacturing: Producing the eptifibatide molecule. This is a critical step, and ensuring a consistent, high-quality supply is paramount. Several API manufacturers likely exist globally.
• Finished Dosage Form Manufacturing: Formulating the API into the injectable solution. This typically involves sterile filling and packaging operations.
• Distribution: Getting the finished product to hospitals, clinics, and pharmacies. This requires cold chain management in some instances, although eptifibatide solutions are generally stable at room temperature.

With generic entry, multiple manufacturers are now involved in API and finished product production. This has increased the robustness of the supply chain but also intensified competition among suppliers. Price negotiations between generic manufacturers and pharmaceutical distributors are a key feature of the current market.

What is the clinical evidence supporting Eptifibatide's efficacy and safety?

Eptifibatide's efficacy and safety have been established through several pivotal clinical trials. The ESPRIT (Enhanced Synergy and Prolongation of Inhibition with Tirofiban or Integrilin Therapy) trial demonstrated the benefit of eptifibatide in patients undergoing PCI. The PURSUIT (Platelet Inhibition in Unstable Angina: Receptor Uptake Inhibition and Tirofiban) trial evaluated its use in ACS.

• Efficacy: Trials have shown that eptifibatide significantly reduces the risk of death, myocardial infarction, and the need for urgent revascularization in patients with ACS and those undergoing PCI. It effectively inhibits platelet aggregation by blocking the binding of fibrinogen to the GP IIb/IIIa receptor.
• Safety: The primary safety concern associated with eptifibatide, like other GP IIb/IIIa inhibitors, is an increased risk of bleeding. This includes minor bleeding (e.g., access site hematoma) and major bleeding events (e.g., intracranial hemorrhage, gastrointestinal bleeding). Careful patient selection and monitoring are essential to manage bleeding risks.

The clinical data, while robust, has been interpreted within evolving treatment paradigms, which has influenced its real-world utilization.

What are the future market trends and potential disruptive factors for Eptifibatide?

The future market for eptifibatide will be shaped by several trends:

• Continued Generic Competition: The market will remain highly competitive with multiple generic suppliers driving down prices. Profit margins for manufacturers will be squeezed.
• Evolving Treatment Guidelines: As new antiplatelet agents and antithrombotic therapies emerge, and understanding of ACS management advances, the role of GP IIb/IIIa inhibitors may further refine.
• Cost-Effectiveness Pressures: Healthcare systems globally are focused on cost containment. Eptifibatide's generic availability positions it as a cost-effective option in certain settings, but this could be challenged by even lower-cost alternatives or newer therapies with demonstrated superior outcomes in specific niches.
• Emerging Markets: Growth may be seen in developing economies where access to advanced therapies is expanding.
• Innovation in Delivery or Formulation: While less likely for a mature product, incremental improvements in delivery or stability could theoretically impact specific market segments, but significant R&D investment is improbable.
• Therapeutic Substitutes: Development of novel oral antiplatelet agents or other antithrombotic strategies could gradually reduce the demand for injectable GP IIb/IIIa inhibitors.

Disruptive factors could include major clinical trial outcomes demonstrating significant advantages for competing drug classes in scenarios where eptifibatide is currently used, or unforeseen supply chain disruptions impacting generic availability.

Key Takeaways

• Eptifibatide's market exclusivity has ended due to patent expiries, leading to widespread generic competition.
• Pricing has dramatically decreased, impacting originator revenue and creating a highly competitive generic market.
• Major generic players including Teva, Dr. Reddy's, Viatris, and Sun Pharma are active in the market.
• The market value has contracted significantly from its branded peak, though volume may be sustained or grow modestly.
• Eptifibatide is indicated for acute coronary syndromes and percutaneous coronary intervention, competing with other GP IIb/IIIa inhibitors and increasingly with P2Y12 inhibitors.
• While effective, its use has become more specialized within evolving ACS treatment guidelines, often reserved for high-risk scenarios.
• Future market trends indicate continued price pressure, potential growth in emerging markets, and the influence of evolving treatment paradigms and cost-effectiveness considerations.

Frequently Asked Questions

1. How does the generic pricing of eptifibatide compare to the original branded product?

Generic eptifibatide is priced significantly lower than the original branded product, with price reductions often exceeding 80% due to competitive market forces.

2. Is eptifibatide still considered a first-line therapy for all acute coronary syndromes?

No, eptifibatide is not a first-line therapy for all ACS patients. Current treatment guidelines typically prioritize P2Y12 inhibitors (like ticagrelor or prasugrel) in combination with aspirin for most ACS patients, with eptifibatide often reserved for high-risk situations or specific procedural contexts.

3. What are the primary risks associated with using eptifibatide?

The most significant risk associated with eptifibatide use is bleeding, which can range from minor to severe.

4. Can eptifibatide be used in patients with known hypersensitivity to its components?

No, eptifibatide should not be administered to patients with known hypersensitivity to eptifibatide or any of its excipients.

5. Are there any contraindications for eptifibatide use besides hypersensitivity?

Other contraindications include active bleeding or a history of bleeding within the past 30 days, and severe thrombocytopenia (platelet count <100,000/mm³).

Citations

[1] U.S. Food & Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from [FDA Orange Book website] (Specific entry for Eptifibatide or Integrilin would be cited if a direct link were feasible and stable, but the general database is the source).

[2] U.S. Patent and Trademark Office. (n.d.). Patents Database. (Specific patent numbers like 4,946,775 and 5,945,407 are referenced as publicly available records).

[3] European Medicines Agency. (n.d.). European Public Assessment Reports. (Records for Integrilin and generic eptifibatide products).

[4] National Institutes of Health. (n.d.). ClinicalTrials.gov. (Databases for ESPRIT and PURSUIT trial results and related publications).

[5] Pharmaceutical industry market research reports (e.g., GlobalData, IQVIA). (General data on market size and competitive landscape for cardiovascular drugs).