EPTIFIBATIDE Drug Patent Profile
✉ Email this page to a colleague
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, Hong Kong, Hybio, 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. Nine 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.
AI Research Assistant
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 |
| Finished Product Suppliers / Packagers: | 9 |
| Raw Ingredient (Bulk) Api Vendors: | 70 |
| Clinical Trials: | 36 |
| Patent Applications: | 4,532 |
| Drug Prices: | Drug price information for EPTIFIBATIDE |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | EPTIFIBATIDE | eptifibatide | INJECTABLE;INJECTION | 205557-001 | Nov 6, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sagent Pharms Inc | EPTIFIBATIDE | eptifibatide | INJECTABLE;INJECTION | 204693-002 | Mar 7, 2018 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms Usa | EPTIFIBATIDE | eptifibatide | INJECTABLE;INJECTION | 091555-001 | Jun 5, 2015 | 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 |
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 |
