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, Hong Kong, Hybio, 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. Nine 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: | 9 |
Raw Ingredient (Bulk) Api Vendors: | 70 |
Clinical Trials: | 36 |
Patent Applications: | 4,881 |
Drug Prices: | Drug price trends for eptifibatide |
What excipients (inactive ingredients) are in eptifibatide? | eptifibatide excipients list |
DailyMed Link: | eptifibatide at DailyMed |
Recent Clinical Trials for eptifibatide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Baylor College of Medicine | Phase 1/Phase 2 |
Assiut University | Phase 1/Phase 2 |
National Institute of Neurological Disorders and Stroke (NINDS) | Phase 3 |
Pharmacology for eptifibatide
Drug Class | Platelet Aggregation Inhibitor |
Physiological Effect | Decreased Platelet Aggregation |
Anatomical Therapeutic Chemical (ATC) Classes 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan Labs Ltd | EPTIFIBATIDE | eptifibatide | INJECTABLE;INJECTION | 203258-002 | Jul 20, 2018 | AP | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Rising | EPTIFIBATIDE | eptifibatide | INJECTABLE;INJECTION | 204589-002 | Apr 18, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Teva Pharms Usa | EPTIFIBATIDE | eptifibatide | INJECTABLE;INJECTION | 090854-001 | Jun 12, 2015 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Hong Kong | EPTIFIBATIDE | eptifibatide | INJECTABLE;INJECTION | 213599-001 | May 9, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Usv | EPTIFIBATIDE | eptifibatide | INJECTABLE;INJECTION | 204362-001 | Mar 11, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Msd Sub Merck | INTEGRILIN | eptifibatide | INJECTABLE;INJECTION | 020718-001 | May 18, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Msd Sub Merck | INTEGRILIN | eptifibatide | INJECTABLE;INJECTION | 020718-002 | May 18, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Msd Sub Merck | INTEGRILIN | eptifibatide | INJECTABLE;INJECTION | 020718-002 | May 18, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Msd Sub Merck | INTEGRILIN | eptifibatide | INJECTABLE;INJECTION | 020718-002 | May 18, 1998 | ⤷ Sign Up | ⤷ Sign Up |
>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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