BIVALIRUDIN Drug Patent Profile
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When do Bivalirudin patents expire, and what generic alternatives are available?
Bivalirudin is a drug marketed by Accord Hlthcare, Apotex, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hospira, Meitheal, Mylan Institutional, Shuangcheng, Slate Run Pharma, and Baxter Hlthcare Corp. and is included in twelve NDAs.
The generic ingredient in BIVALIRUDIN is bivalirudin. There are fourteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the bivalirudin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Bivalirudin
A generic version of BIVALIRUDIN was approved as bivalirudin by HOSPIRA on July 14th, 2015.
Summary for BIVALIRUDIN
| US Patents: | 0 |
| Applicants: | 11 |
| NDAs: | 12 |
| Finished Product Suppliers / Packagers: | 11 |
| Raw Ingredient (Bulk) Api Vendors: | 61 |
| Clinical Trials: | 71 |
| Patent Applications: | 4,430 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information 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 |
|---|---|
| Veralox Therapeutics | Phase 2 |
| University Magna Graecia | N/A |
| Johns Hopkins University | Phase 1 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | BIVALIRUDIN | bivalirudin | INJECTABLE;INTRAVENOUS | 206551-001 | Nov 22, 2017 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hospira | BIVALIRUDIN | bivalirudin | INJECTABLE;INTRAVENOUS | 090816-001 | Jul 14, 2015 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Eugia Pharma | BIVALIRUDIN | bivalirudin | INJECTABLE;INTRAVENOUS | 205962-001 | Jul 27, 2018 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Baxter Hlthcare Corp | BIVALIRUDIN IN 0.9% SODIUM CHLORIDE | bivalirudin | SOLUTION;INTRAVENOUS | 208374-001 | Dec 21, 2017 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Meitheal | BIVALIRUDIN | bivalirudin | INJECTABLE;INTRAVENOUS | 091602-001 | Jul 16, 2018 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Apotex | BIVALIRUDIN | bivalirudin | INJECTABLE;INTRAVENOUS | 204876-001 | Jul 6, 2017 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Dr Reddys | BIVALIRUDIN | bivalirudin | INJECTABLE;INTRAVENOUS | 201577-001 | May 26, 2017 | AP | RX | 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 |
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 |
