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Last Updated: March 28, 2024

EPTIFIBATIDE - Generic Drug Details


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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, Mylan Labs Ltd, Rising, Sagent Pharms Inc, Shuangcheng, Slate Run Pharma, Teva Pharms Usa, USV, and Msd Sub Merck, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for EPTIFIBATIDE

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Recent Clinical Trials for EPTIFIBATIDE

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SponsorPhase
Baylor College of MedicinePhase 1/Phase 2
Assiut UniversityPhase 1/Phase 2
University of CincinnatiPhase 3

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Pharmacology for EPTIFIBATIDE
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
Msd Sub Merck INTEGRILIN eptifibatide INJECTABLE;INJECTION 020718-001 May 18, 1998 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Slate Run Pharma EPTIFIBATIDE eptifibatide INJECTABLE;INJECTION 209864-002 Jan 25, 2019 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Usv EPTIFIBATIDE eptifibatide INJECTABLE;INJECTION 204361-001 Mar 14, 2019 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

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/004104
Eptifibatide 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/000230
Integrilin 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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