Bivalirudin - PharmaKB

Angiomax, Angiox(bivalirudin)

Angiomax, Angiox (bivalirudin) is a protein pharmaceutical. Bivalirudin was first approved as Angiomax on 2000-12-15. It is used to treat unstable angina in the USA. It has been approved in Europe to treat acute coronary syndrome. The pharmaceutical is active against prothrombin.

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Clinical

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YTD

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
cardiovascular diseases	D002318
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Angiomax, Bivalirudin (discontinued: Bivalirudin)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Bivalirudin

Tradename	Company	Number	Date	Products
ANGIOMAX RTU	MAIA Biotechnology	N-211215 RX	2019-07-25	1 products, RLD, RS
ANGIOMAX	Sandoz	N-020873 RX	2000-12-15	1 products, RLD, RS

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Labels

FDA

EMA

Brand Name	Status	Last Update
bivalirudin	ANDA	2026-08-20

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
unstable angina	EFO_1000985	D000789	I20.0

Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag	FDA Information
Bivalirudin, Angiomax Rtu, Maia Pharms Inc
11903993	2039-05-20		U-3817
11918622	2039-05-20		U-3817
Bivalirudin, Angiomax, Sandoz
7582727	2028-07-27	DP
7598343	2028-07-27	DP

ATC Codes

B: Blood and blood forming organ drugs

— B01: Antithrombotic agents

— B01A: Antithrombotic agents

— B01AE: Direct thrombin inhibitors

— B01AE06: Bivalirudin

HCPCS

Code	Description
J0583	Injection, bivalirudin, 1 mg

Clinical

Clinical Trials

92 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Myocardial infarction	D009203	EFO_0000612	I21	—	1	8	13	4	26
Infarction	D007238	EFO_0009463	—	—	1	5	11	4	21
Coronary artery disease	D003324	—	I25.1	—	1	2	10	4	17
St elevation myocardial infarction	D000072657	—	—	—	1	1	9	3	14
Acute coronary syndrome	D054058	EFO_0005672	—	—	—	5	7	1	13
Coronary disease	D003327	—	—	—	1	1	6	3	11
Myocardial ischemia	D017202	EFO_1001375	I20-I25	—	1	1	4	2	8
Percutaneous coronary intervention	D062645	—	—	—	—	2	5	—	7
Hemorrhage	D006470	MP_0001914	R58	—	—	4	1	1	6
Syndrome	D013577	—	—	—	—	2	3	1	6

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Heart failure	D006333	EFO_0003144	I50	—	1	1	—	2	4
Coronary artery bypass	D001026	EFO_0003776	—	—	—	4	—	—	4
Cardiovascular diseases	D002318	EFO_0000319	I98	—	—	3	—	—	3
Necrosis	D009336	—	—	—	—	2	—	—	2
Acute disease	D000208	—	—	—	—	1	—	—	1
Subarachnoid hemorrhage	D013345	EFO_0000713	I60	—	—	1	—	—	1
Aneurysm	D000783	—	I72.9	—	—	1	—	—	1
Intracranial aneurysm	D002532	EFO_0003870	I67.1	—	—	1	—	—	1
Endovascular procedures	D057510	—	—	—	—	1	—	—	1
Aortic valve stenosis	D001024	EFO_0000266	—	—	—	1	—	—	1

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Carotid artery diseases	D002340	EFO_0003781	—	—	1	—	—	—	1
Cardiogenic shock	D012770	—	R57.0	—	1	—	—	—	1
Congenital heart defects	D006330	—	Q24.9	—	1	—	—	—	1
Cardiomyopathies	D009202	EFO_0000318	I42	—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Venous thrombosis	D020246	—	I82.40	1	—	—	—	—	1
Healthy volunteers/patients	—	—	—	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Stable angina	D060050	—	I20.89	—	—	—	—	2	2
Hypertension	D006973	EFO_0000537	I10	—	—	—	—	1	1
Coronavirus infections	D018352	EFO_0007224	B34.2	—	—	—	—	1	1
Menorrhagia	D008595	EFO_0003945	N92.0	—	—	—	—	1	1
Hemophilia a	D006467	EFO_0007267	D66	—	—	—	—	1	1
Pain	D010146	EFO_0003843	R52	—	—	—	—	1	1
Down syndrome	D004314	EFO_0001064	Q90	—	—	—	—	1	1
Pneumonia	D011014	EFO_0003106	J18	—	—	—	—	1	1
Mucocutaneous lymph node syndrome	D009080	EFO_0004246	M30.3	—	—	—	—	1	1
Hyperaldosteronism	D006929	—	E26	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Bivalirudin
INN	bivalirudin
Description	Bivalirudin is a synthetic peptide of 20 amino acids, comprising D-Phe, Pro, Arg, Pro, Gly, Gly, Gly, Gly, Asn, Gly, Asp, Phe, Glu, Glu, Ile, Pro, Glu, Glu, Tyr, and Leu in sequence. A congener of hirudin (a naturally occurring drug found in the saliva of the medicinal leech), it a specific and reversible inhibitor of thrombin, and is used as an anticoagulant. It has a role as an anticoagulant and an EC 3.4.21.5 (thrombin) inhibitor.
Classification	Protein
Drug class	anticoagulants (hirudin type)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CC[C@H](C)[C@H](NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(=O)O)NC(=O)CNC(=O)[C@H](CC(N)=O)NC(=O)CNC(=O)CNC(=O)CNC(=O)CNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H]1CCCN1C(=O)[C@H](N)Cc1ccccc1)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1ccc(O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)O