Bivalirudin

Overview

Bivalirudin is a synthetic 20 residue peptide (thrombin inhibitor) which reversibly inhibits thrombin. Once bound to the active site, thrombin cannot activate fibrinogen into fibrin, the crucial step in the formation of thrombus. It is administered intravenously. Because it can cause blood stagnation, it is important to monitor changes in hematocrit, activated partial thromboplastin time, international normalized ratio and blood pressure.

Indication

For treatment of heparin-induced thrombocytopenia and for the prevention of thrombosis. Bivalirudin is indicated for use in patients undergoing percutaneous coronary intervention (PCI), in patients at moderate to high risk acute coronary syndromes due to unstable angina or non-ST segment elevation in whom a PCI is planned.

Associated Conditions

Thrombosis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Bivalirudin with Prolonged Infusion During PCI Versus Heparin After Fibrinolytic Therapy	2025/03/06	NCT06861374	Not Applicable	Not yet recruiting	First Affiliated Hospital Xi'an Jiaotong University
Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation	2024/02/23	NCT06275555	Not Applicable	Not yet recruiting	Xiaotong Hou
A Study on the Impact of Bivalirudin Usage During PCI for High-risk Plaques on Post-PCI Coronary Microcirculation.	2023/08/09	NCT05984537	Phase 4	Recruiting	Peking University First Hospital
BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation	2023/07/25	NCT05959252	Phase 2	Recruiting	Sydney Local Health District
Bivalirudin Versus Enoxaparin in Critically Ill COVID-19 Patients	2022/04/19	NCT05334654	Not Applicable	Completed	University Magna Graecia
Efficacy and Safety of Bivalirudin Versus Heparin During Coil Embolization in Patients With Ruptured Intracranial Aneurysms	2020/08/31	NCT04532333	Phase 3	UNKNOWN	Changhai Hospital
Safety and Efficacy of Bivalirudin During Short-term Intervention of Non-infarction Related Artery After PPCI of STEMI	2020/07/17	NCT04475835	Not Applicable	UNKNOWN	First Affiliated Hospital Xi'an Jiaotong University
Anticoagulation in Patients Suffering From COVID-19 Disease The ANTI-CO Trial	2020/06/24	NCT04445935	Phase 4	UNKNOWN	Hamad Medical Corporation
Multi-center Application of Bivalirudin in Left Atrial Appendage Occlusion	2019/12/12	NCT04195997	Phase 4	UNKNOWN	Shanghai Zhongshan Hospital
Bivalirudin in Late PCI for Oatients With STEMI	2019/12/04	NCT04185077	Phase 4	UNKNOWN	Second Xiangya Hospital of Central South University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
bivalirudin	Civica, Inc.	72572-035	INTRAVENOUS	250 mg in 1 1	7/20/2020
bivalirudin	Sandoz Inc	0781-9158	INTRAVENOUS	250 mg in 1 1	9/30/2019
BIVALIRUDIN	Eugia US LLC	55150-210	INTRAVENOUS	250 mg in 1 1	8/23/2023
bivalirudin	Slate Run Pharmaceuticals, LLC	70436-025	INTRAVENOUS	250 mg in 1 1	6/9/2021
Bivalirudin	Avenacy, Inc.	83634-400	INTRAVENOUS	250 mg in 1 1	12/18/2023
bivalirudin	Pharma Packaging Solutions, LLC dba Tjoapack LLC	75929-217	INTRAVENOUS	250 mg in 1 1	3/7/2024
Bivalirudin	Fresenius Kabi USA, LLC	63323-562	INTRAVENOUS	250 mg in 1 1	10/28/2016
Angiomax	Sandoz Inc	0781-3447	INTRAVENOUS	250 mg in 1 1	6/30/2019
Bivalirudin	Mylan Institutional LLC	67457-256	INTRAVENOUS	250 mg in 5 mL	3/7/2017
Bivalirudin	Hospira, Inc.	0409-8300	INTRAVENOUS	250 mg in 1 1	8/1/2019

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
BIVALIRUDIN SXP bivalirudin (as trifluoroacetate) 250 mg powder for injection vial	388791	Southern XP IP Pty Ltd	Medicine	A	6/8/2023
BIVALIRUDIN JUNO bivalirudin (as trifluoroacetate) 250mg Powder for Injection vial	226748	Juno Pharmaceuticals Pty Ltd	Medicine	A	7/24/2015
Bivalirudin ARX bivalirudin (as trifluoroacetate) 250mg powder for injection vial	241714	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/17/2016
BIVALIRUDIN ANS bivalirudin (as trifluoroacetate) 250 mg powder for injection vial	388792	Southern XP IP Pty Ltd	Medicine	A	6/8/2023
BIVALIRUDIN MEDSURGE bivalirudin (as trifluoroacetate) 250 mg powder for injection vial	427182	Medsurge Pharma Pty Ltd	Medicine	A	7/9/2025
BIVALIRUDIN MEDICIANZ bivalirudin (as trifluoroacetate) 250 mg powder for injection vial	427181	Medsurge Pharma Pty Ltd	Medicine	A	7/9/2025
BIVALIRUDIN HMH bivalirudin (as trifluoroacetate) 250 mg powder for injection vial	388790	Southern XP IP Pty Ltd	Medicine	A	6/8/2023
GenRx Bivalirudin bivalirudin (as trifluoroacetate) 250mg powder for injection vial	241712	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/17/2016
APO-Bivalirudin bivalirudin (as trifluoroacetate) 250mg powder for injection vial	241713	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/17/2016
BIVALIRUDIN AC bivalirudin (as trifluoroacetate) 250mg Powder for Injection vial	226749	Juno Pharmaceuticals Pty Ltd	Medicine	A	7/24/2015

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
BIVALIRUDIN FOR INJECTION	fresenius kabi canada ltd	02435268	Powder For Solution - Intravenous	250 MG / VIAL	4/23/2019
BIVALIRUDIN FOR INJECTION	formative pharma inc.	02539586	Powder For Solution - Intravenous	250 MG / VIAL	9/10/2024
BIVALIRUDIN FOR INJECTION	Juno Pharmaceuticals Corp.	02511452	Powder For Solution - Intravenous	250 MG / VIAL	5/1/2023
BIVALIRUDIN	Sandoz Canada, Inc.	02450402	Powder For Solution - Intravenous	250 MG / VIAL	N/A
ANGIOMAX	Sandoz Canada, Inc.	02246533	Powder For Solution - Intravenous	250 MG / VIAL	5/8/2003
BIVALIRUDIN INJECTION	avir pharma inc.	02505517	Solution - Intravenous	5 MG / ML	3/5/2021
BIVALIRUDIN FOR INJECTION	dr reddy's laboratories ltd	02518643	Powder For Solution - Intravenous	250 MG / VIAL	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
BIVALIRUDINA ACCORD 250 MG DE POLVO PARA CONCENTRADO PARA SOLUCION INYECTABLE Y PARA PERFUSION EFG	Accord Healthcare S.L.U.	81564	POLVO PARA CONCENTRADO PARA SOLUCION INYECTABLE Y PARA PERFUSION	Uso Hospitalario	Not Commercialized
BIVALIRUDINA SALA 250 MG POLVO PARA CONCENTRADO PARA SOLUCION INYECTABLE O PERFUSION EFG	Laboratorio Reig Jofre, S.A.	80912	POLVO PARA CONCENTRADO PARA SOLUCION INYECTABLE Y PARA PERFUSION	Uso Hospitalario	Commercialized
BIVALIRUDINA CIPLA 250 MG POLVO PARA CONCENTRADO PARA SOLUCION INYECTABLE Y PARA PERFUSION EFG	Cipla Europe	81587	POLVO PARA CONCENTRADO PARA SOLUCION INYECTABLE Y PARA PERFUSION	Uso Hospitalario	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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