You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 18, 2026

EPTIFIBATIDE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Eptifibatide patents expire, and when can generic versions of Eptifibatide launch?

Eptifibatide is a drug 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, and USV. and is included in fifteen NDAs.

The generic ingredient in EPTIFIBATIDE is eptifibatide. There are fifteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the eptifibatide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Eptifibatide

A generic version of EPTIFIBATIDE was approved as eptifibatide by TEVA PHARMS USA on June 12th, 2015.

  Get Started Free

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for EPTIFIBATIDE?
  • What are the global sales for EPTIFIBATIDE?
  • What is Average Wholesale Price for EPTIFIBATIDE?
Summary for EPTIFIBATIDE
US Patents:0
Applicants:13
NDAs:15
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
Accord Hlthcare EPTIFIBATIDE eptifibatide INJECTABLE;INJECTION 205557-001 Nov 6, 2017 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sagent Pharms Inc EPTIFIBATIDE eptifibatide INJECTABLE;INJECTION 204693-002 Mar 7, 2018 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Teva Pharms Usa EPTIFIBATIDE eptifibatide INJECTABLE;INJECTION 091555-001 Jun 5, 2015 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Eugia Pharma EPTIFIBATIDE eptifibatide INJECTABLE;INJECTION 206127-001 Dec 8, 2015 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Investment Scenario, Market Dynamics, and Financial Trajectory for Eptifibatide

Last updated: February 3, 2026

Executive Summary

Eptifibatide, marketed as Integrilin®, is an injectable glycoprotein IIb/IIIa receptor antagonist used primarily in the management of acute coronary syndromes (ACS) and during percutaneous coronary intervention (PCI). Its market landscape is shaped by clinical efficacy, competitive positioning, regulatory approvals, and broader trends in cardiac care. This analysis explores Eptifibatide’s current market status, potential growth drivers, competitive dynamics, revenue projections, and investment implications through 2030.


What is the Current Market Position of Eptifibatide?

Market Overview

Parameter Details
Approved Indications ACS (Unstable Angina/NSTEMI, STEMI), PCI
Formulation Intravenous, Bolus + infusion
Marketed Since 1998
Key Manufacturers Merck & Co. (Johnson & Johnson after acquisition)
Patent Status Patent expired (2008); biosimilars/differents under regulatory review

Eptifibatide operates in a highly competitive space involving other GPIIb/IIIa antagonists (eptifibatide, abciximab, tirofiban) alongside evolving antithrombotic agents like P2Y12 inhibitors (clopidogrel, ticagrelor), and newer oral anticoagulants (NOACs). The drug’s use cases are primarily within episodic, interventional, hospital-based settings.

Market Revenue and Volume Data

Year Estimated Global Sales (USD millions) Notes
2021 ~$150 Stabilized due to declining indications
2022 ~$140 Slight decline; market saturation
2023 ~$135 Competitive shifts; hospital usage trends

Note: The sales plateau reflects broader clinical practice shifts towards alternative therapies and biosimilars.


How Do Market Dynamics Influence Eptifibatide’s Investment Outlook?

Key Drivers

Driver Impact Evidence/Trend
Regulatory Environment Facilitates or restricts new approvals FDA/Biocon [1], EMA approvals, biosimilar pathways
Clinical Guidelines Updates Determines prescribing prevalence Inclusions in ACC/AHA guidelines influence uptake
Competitive Therapeutics Biosimilars and new oral agents reduce market share Emergence of potent P2Y12 inhibitors, NOACs
Hospital Adoption Trends Hospital formularies, procedural preferences Shift towards oral agents for secondary prevention
Market Penetration Strategies Mergers, acquisitions, direct marketing Merck’s previous marketing efforts

Regulatory and Policy Impact

Policy Aspect Effect on Investment
Biosimilar Approvals Potential reduction in pricing and revenue
Patent Expirations Accelerate market entry for biosimilars/licensees
Reimbursement Policies Affect hospital adoption and volume

Competitive Landscape

Competitors Key Advantages Market Position
Abciximab (ReoPro) Longer market presence, established usage Slightly broader clinical acceptance
Tirofiban (Aggrastat) Slightly lower cost, shorter infusion time Competition in coronary intervention
Biosimilar Eptifibatide (pending) Cost reduction, generic entry Emerging threat, regulatory status pending
Oral P2Y12 Inhibitors Ease of administration, outpatient use Growing preference outside acute settings

What Is the Projected Financial Trajectory for Eptifibatide Through 2030?

Revenue Forecasts and Assumptions

Year Estimated Global Sales (USD millions) Assumptions
2024 ~$130 Slight decline, stabilization
2025 ~$125 Biosimilar entry, genericization effect
2026 ~$115 Competition intensifies
2027 ~$100 Declining hospital usage, equipment shifts
2028 ~$90 Increased biosimilar prevalence
2029 ~$80 Market share loss, alternative therapies rising
2030 ~$70 Continued erosion, possible niche status

Key Variables: Patent expiration impacts, biosimilar approvals, clinical guideline shifts, and physician preferences.

Cost and Margin Considerations

Parameter Details
Manufacturing Cost (per dose) Estimated at USD 50 based on API, formulation, quality controls
Average Wholesale Price (AWP) USD 150–200 per dose, with discounts and negotiations
Gross Margin Approx. 65-70% initially, declining with biosimilar entry

How Do Investment Opportunities Evolve with Market Dynamics?

Potential Growth Segments

Segment Opportunity
Hospital Procurement Streamlining supply chains, exclusive formulary agreements
Biosimilar Entry Early licensing, patent litigation strategies
Companion Diagnostics and Devices Development of diagnostic tools to optimize use
International Markets Expanding into emerging markets with growing CVD rates

Risks and Challenges for Investors

Risk Factor Implication
Patent Challenges Could lead to increased biosimilar competition
Clinical Practice Shifts Reduced hospital use as outpatient or oral therapies become dominant
Regulatory Bottlenecks Delays in biosimilar approval or new indications
Funding for R&D and Trials Potential delays or discontinuation of new formulations

How Does Eptifibatide Compare to Other GPIIb/IIIa Inhibitors?

Aspect Eptifibatide Abciximab Tirofiban
Administration Intravenous, bolus + infusion Intravenous, bolus + infusion Intravenous, continuous infusion
Indications ACS, PCI PCI, unstable angina PCI, ACS
Market Share Moderate Dominant historically Competitive alternative
Patent Status Expired (2008) Patented/TlA (1991) Patented (1988, generics emerging)
Cost Higher Higher Lower

Clinical Efficacy and Safety

Evaluation Parameter Eptifibatide Competitor Notes
Efficacy in ACS Proven safety and effectiveness Comparable outcomes
Bleeding Risks Slightly elevated but manageable Similar adverse profiles
Reversibility Short half-life, reversible Reversible for abciximab only

What Are the FAQs Related to Eptifibatide Investment?

  1. What factors most influence eptifibatide’s revenue decline?
    Patent expiration, biosimilar development, shifts toward oral antithrombotics, and changing clinical guidelines lead to reduced hospital use, impacting revenue.

  2. Is biosimilar competition likely to erode profitability?
    Yes. Pending biosimilar approvals may reduce prices and market share, especially in regions with aggressive generic policies.

  3. What new markets or indications could reignite growth for eptifibatide?
    Expansion into emerging markets with high CVD prevalence and exploratory uses in thrombotic disorders present potential growth avenues.

  4. How do regulatory policies impact biosimilar entry?
    Regulatory pathways such as the FDA’s biosimilar approval process (since 2015) can expedite generic entry, affecting market dynamics.

  5. What strategies can investors employ to mitigate risks associated with eptifibatide?
    Diversification into adjacent therapeutic areas, early engagement with biosimilar developments, and monitoring clinical guideline updates mitigate downside risks.


Key Takeaways

  • Market Maturity and Patent Expiry: Eptifibatide’s branded sales peak pre-2008, with subsequent decline driven by biosimilars and evolving treatment standards.
  • Competitive Dynamics: The growth of oral antithrombotics and new anticoagulants diminishes IV GPIIb/IIIa inhibitors' relevance outside hospital settings.
  • Investment Trajectory: Revenue forecasts show a decline to approximately USD 70 million by 2030, contingent on biosimilar market entry and clinical guideline shifts.
  • Growth Opportunities: International expansion, biosimilar licensing, and niche applications may offer salvageable growth paths.
  • Risk Management: Robust patent strategies, diversification, and close monitoring of regulatory landscapes are critical for investors.

References

[1] FDA Biosimilar Policy and Approval Pathways, 2015–2022.
[2] MarketResearch.com, "Global GPIIb/IIIa Inhibitors Market," 2022.
[3] Clinical Guidelines on ACS Management, American College of Cardiology, 2021.
[4] Biosimilar Approvals and Patent Litigation Reports, WHO, 2022.
[5] Merck & Co. Financial Reports, 2021–2023.


This report serves as a comprehensive resource for investment decisions related to eptifibatide, aligning with current market and regulatory insights.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.