BIVALIRUDIN - Generic Drug Details
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What are the generic drug sources for bivalirudin and what is the scope of freedom to operate?
Bivalirudin
is the generic ingredient in four branded drugs marketed by Sandoz, Accord Hlthcare, Apotex, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hospira, Meitheal, Mylan Institutional, Shuangcheng, Slate Run Pharma, Maia Pharms Inc, and Baxter Hlthcare Corp, and is included in fourteen NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.There are fourteen drug master file entries for bivalirudin. Fifteen suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for BIVALIRUDIN
US Patents: | 5 |
Tradenames: | 4 |
Applicants: | 13 |
NDAs: | 14 |
Drug Master File Entries: | 14 |
Finished Product Suppliers / Packagers: | 15 |
Raw Ingredient (Bulk) Api Vendors: | 61 |
Clinical Trials: | 72 |
Patent Applications: | 5,830 |
Drug Prices: | Drug price trends for BIVALIRUDIN |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BIVALIRUDIN |
What excipients (inactive ingredients) are in BIVALIRUDIN? | BIVALIRUDIN excipients list |
DailyMed Link: | BIVALIRUDIN at DailyMed |
Recent Clinical Trials for BIVALIRUDIN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Sydney Local Health District | Phase 2 |
Veralox Therapeutics | Phase 2 |
University Magna Graecia | N/A |
Generic filers with tentative approvals for BIVALIRUDIN
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 250MG/VIAL | INJECTABLE;INTRAVENOUS |
⤷ Sign Up | ⤷ Sign Up | 250MG/VIAL | INJECTABLE;INJECTION |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for BIVALIRUDIN
Drug Class | Anti-coagulant Direct Thrombin Inhibitor |
Mechanism of Action | Thrombin Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for BIVALIRUDIN
Paragraph IV (Patent) Challenges for BIVALIRUDIN
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ANGIOMAX | For Injection | bivalirudin | 250 mg/vial | 020873 | 1 | 2009-09-01 |
US Patents and Regulatory Information for BIVALIRUDIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan Institutional | BIVALIRUDIN | bivalirudin | INJECTABLE;INTRAVENOUS | 202471-001 | Jun 1, 2018 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Baxter Hlthcare Corp | BIVALIRUDIN IN 0.9% SODIUM CHLORIDE | bivalirudin | SOLUTION;INTRAVENOUS | 208374-001 | Dec 21, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Baxter Hlthcare Corp | BIVALIRUDIN IN 0.9% SODIUM CHLORIDE | bivalirudin | SOLUTION;INTRAVENOUS | 208374-002 | Dec 21, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Apotex | BIVALIRUDIN | bivalirudin | INJECTABLE;INTRAVENOUS | 204876-001 | Jul 6, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Maia Pharms Inc | ANGIOMAX RTU | bivalirudin | SOLUTION;INTRAVENOUS | 211215-001 | Jul 25, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Slate Run Pharma | BIVALIRUDIN | bivalirudin | INJECTABLE;INTRAVENOUS | 213078-001 | May 28, 2021 | AP | RX | 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 BIVALIRUDIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sandoz | ANGIOMAX | bivalirudin | INJECTABLE;INTRAVENOUS | 020873-001 | Dec 15, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for BIVALIRUDIN
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
The Medicines Company UK Ltd | Angiox | bivalirudin | EMEA/H/C/000562 Angiox is indicated as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment-elevation myocardial infarction (STEMI) undergoing primary PCI.Angiox is also indicated for the treatment of adult patients with unstable angina / non-ST-segment-elevation myocardial infarction (UA / NSTEMI) planned for urgent or early intervention.Angiox should be administered with aspirin and clopidogrel. |
Withdrawn | no | no | no | 2004-09-20 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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