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    Also known as: 128270-60-0, Angiomax, Bivalirudin trifluoroacetate, Bg-8967, Bg8967, Hirulog
    Molecular Formula
    C98H138N24O33
    Molecular Weight
    2180.3  g/mol
    InChI Key
    OIRCOABEOLEUMC-GEJPAHFPSA-N
    Bivalirudin
    Bivalirudin is a 20 amino acid long synthetic peptide with thrombin-specific anticoagulant properties. Bivalirudin reversibly binds thrombin, free as well as clot bound, at the catalytic site and the anion-binding exosite, thereby preventing the formation and activation of fibrin, factor XIIIa, and other coagulation factors. This drug is primarily used during coronary angioplasty procedures, in combination with aspirin, in patients with unstable angina.
    1 2D Structure

    Bivalirudin

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-1-[(2S,3S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[2-[[(2S)-4-amino-2-[[2-[[2-[[2-[[2-[[(2S)-1-[(2S)-2-[[(2S)-1-[(2R)-2-amino-3-phenylpropanoyl]pyrrolidine-2-carbonyl]amino]-5-carbamimidamidopentanoyl]pyrrolidine-2-carbonyl]amino]acetyl]amino]acetyl]amino]acetyl]amino]acetyl]amino]-4-oxobutanoyl]amino]acetyl]amino]-3-carboxypropanoyl]amino]-3-phenylpropanoyl]amino]-4-carboxybutanoyl]amino]-4-carboxybutanoyl]amino]-3-methylpentanoyl]pyrrolidine-2-carbonyl]amino]-4-carboxybutanoyl]amino]-4-carboxybutanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-4-methylpentanoic acid
    2.1.2 InChI
    InChI=1S/C98H138N24O33/c1-5-52(4)82(96(153)122-39-15-23-70(122)92(149)114-60(30-34-79(134)135)85(142)111-59(29-33-78(132)133)86(143)116-64(43-55-24-26-56(123)27-25-55)89(146)118-67(97(154)155)40-51(2)3)119-87(144)61(31-35-80(136)137)112-84(141)58(28-32-77(130)131)113-88(145)63(42-54-18-10-7-11-19-54)117-90(147)66(45-81(138)139)110-76(129)50-107-83(140)65(44-71(100)124)109-75(128)49-106-73(126)47-104-72(125)46-105-74(127)48-108-91(148)68-21-13-38-121(68)95(152)62(20-12-36-103-98(101)102)115-93(150)69-22-14-37-120(69)94(151)57(99)41-53-16-8-6-9-17-53/h6-11,16-19,24-27,51-52,57-70,82,123H,5,12-15,20-23,28-50,99H2,1-4H3,(H2,100,124)(H,104,125)(H,105,127)(H,106,126)(H,107,140)(H,108,148)(H,109,128)(H,110,129)(H,111,142)(H,112,141)(H,113,145)(H,114,149)(H,115,150)(H,116,143)(H,117,147)(H,118,146)(H,119,144)(H,130,131)(H,132,133)(H,134,135)(H,136,137)(H,138,139)(H,154,155)(H4,101,102,103)/t52-,57+,58-,59-,60-,61-,62-,63-,64-,65-,66-,67-,68-,69-,70-,82-/m0/s1
    2.1.3 InChI Key
    OIRCOABEOLEUMC-GEJPAHFPSA-N
    2.1.4 Canonical SMILES
    CCC(C)C(C(=O)N1CCCC1C(=O)NC(CCC(=O)O)C(=O)NC(CCC(=O)O)C(=O)NC(CC2=CC=C(C=C2)O)C(=O)NC(CC(C)C)C(=O)O)NC(=O)C(CCC(=O)O)NC(=O)C(CCC(=O)O)NC(=O)C(CC3=CC=CC=C3)NC(=O)C(CC(=O)O)NC(=O)CNC(=O)C(CC(=O)N)NC(=O)CNC(=O)CNC(=O)CNC(=O)CNC(=O)C4CCCN4C(=O)C(CCCNC(=N)N)NC(=O)C5CCCN5C(=O)C(CC6=CC=CC=C6)N
    2.1.5 Isomeric SMILES
    CC[C@H](C)[C@@H](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](CC2=CC=C(C=C2)O)C(=O)N[C@@H](CC(C)C)C(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC3=CC=CC=C3)NC(=O)[C@H](CC(=O)O)NC(=O)CNC(=O)[C@H](CC(=O)N)NC(=O)CNC(=O)CNC(=O)CNC(=O)CNC(=O)[C@@H]4CCCN4C(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H]5CCCN5C(=O)[C@@H](CC6=CC=CC=C6)N
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Angiomax

    2. Angiomax Rtu

    3. Bg 8967

    4. Bg-8967

    5. Bg8967

    6. Bivalirudin Trifluoroacetate

    7. Ctb-001

    8. Hirulog

    9. Hirulog-1

    10. L-leucine, D-phenylalanyl-l-prolyl-l-arginyl-l-prolylglycylglycylglycylglycyl-l-asparaginylglycyl-l-alpha-aspartyl-l-phenylalanyl-l-alpha-glutamyl-l-alpha-glutamyl-l-isoleucyl-l-prolyl-l-alpha-glutamyl-l-alpha-glutamyl-l-tyrosyl-

    11. Phe-pro-arg-pro-(gly)4 Desulfato-tyr63'-hirugen

    12. Phe-pro-arg-pro-(gly)4-asn-gly-asp-phe-glu-glu-ile-pro-glu-glu-tyr-leu

    13. Phe-pro-arg-pro-(gly)4-desulfohirudin-(53-64)

    2.2.2 Depositor-Supplied Synonyms

    1. 128270-60-0

    2. Angiomax

    3. Bivalirudin Trifluoroacetate

    4. Bg-8967

    5. Bg8967

    6. Hirulog

    7. Chebi:59173

    8. Hirulog-1

    9. D-phenylalanyl-l-prolyl-l-arginyl-l-prolylglycylglycylglycylglycyl-l-asparaginylglycyl-l-alpha-aspartyl-l-phenylalanyl-l-alpha-glutamyl-l-alpha-glutamyl-l-isoleucyl-l-prolyl-l-alpha-glutamyl-l-alpha-glutamyl-l-tyrosyl-l-leucine

    10. L-leucine, D-phenylalanyl-l-prolyl-l-arginyl-l-prolylglycylglycylglycylglycyl-l-asparaginylglycyl-l-alpha-aspartyl-l-phenylalanyl-l-alpha-glutamyl-l-alpha-glutamyl-l-isoleucyl-l-prolyl-l-alpha-glutamyl-l-alpha-glutamyl-l-tyrosyl-

    11. Angiox

    12. Bivalirudina

    13. Bivalirudine

    14. Bivalirudinum

    15. Bg 8967

    16. Unii-tn9bex005g

    17. Bivalirudin [usan:inn:ban]

    18. Bivalirudin Tfa

    19. 1191386-55-6

    20. Hs-2004

    21. Tn9bex005g

    22. Schembl25739

    23. Gtpl6470

    24. Bivalirudin Trifluoroacetate Salt

    25. Chembl2103749

    26. Dtxsid00155847

    27. Bivalirudin;0.9% Sodium Chloride

    28. Ex-a5843

    29. Bdbm50248103

    30. Mfcd08692016

    31. Akos015994644

    32. Db00006

    33. 70b600

    34. 270b600

    35. J-005587

    36. Q4919218

    37. Bivalirudin Trifluoroacetate (h-dl-phe-dl-pro-dl-arg-dl-pro-gly-gly-gly-gly-dl-asn-gly-dl-asp-dl-phe-dl-glu-dl-glu-xiile-dl-pro-dl-glu-dl-glu-dl-tyr-dl-leu-oh.tfa)

    2.3 Create Date
    2007-07-03
    3 Chemical and Physical Properties
    Molecular Weight 2180.3 g/mol
    Molecular Formula C98H138N24O33
    XLogP3-7.1
    Hydrogen Bond Donor Count28
    Hydrogen Bond Acceptor Count35
    Rotatable Bond Count67
    Exact Mass2179.9891678 g/mol
    Monoisotopic Mass2178.9858129 g/mol
    Topological Polar Surface Area902 Ų
    Heavy Atom Count155
    Formal Charge0
    Complexity4950
    Isotope Atom Count0
    Defined Atom Stereocenter Count16
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameAngiomax
    PubMed HealthBivalirudin (Injection)
    Drug ClassesAnticoagulant
    Drug LabelAngiomax is a specific and reversible direct thrombin inhibitor. The active substance is a synthetic, 20amino acid peptide. The chemical name is D-phenylalanyl-L-prolyl-L-arginyl-L-prolyl-glycyl-glycyl-glycyl-glycyl-L-asparagyl-glycyl-L-aspartyl-L-...
    Active IngredientBivalirudin
    Dosage FormInjectable
    RouteIntravenous
    Strength250mg/vial
    Market StatusPrescription
    CompanyMedicines

    2 of 4  
    Drug NameBivalirudin
    PubMed HealthBivalirudin (Injection)
    Drug ClassesAnticoagulant
    Drug LabelAngiomax is a specific and reversible direct thrombin inhibitor. The active substance is a synthetic, 20amino acid peptide. The chemical name is D-phenylalanyl-L-prolyl-L-arginyl-L-prolyl-glycyl-glycyl-glycyl-glycyl-L-asparagyl-glycyl-L-aspartyl-L-...
    Active IngredientBivalirudin
    Dosage FormInjectable
    Routeinjection
    Strength250mg
    Market StatusTentative Approval
    CompanyHospira

    3 of 4  
    Drug NameAngiomax
    PubMed HealthBivalirudin (Injection)
    Drug ClassesAnticoagulant
    Drug LabelAngiomax is a specific and reversible direct thrombin inhibitor. The active substance is a synthetic, 20amino acid peptide. The chemical name is D-phenylalanyl-L-prolyl-L-arginyl-L-prolyl-glycyl-glycyl-glycyl-glycyl-L-asparagyl-glycyl-L-aspartyl-L-...
    Active IngredientBivalirudin
    Dosage FormInjectable
    RouteIntravenous
    Strength250mg/vial
    Market StatusPrescription
    CompanyMedicines

    4 of 4  
    Drug NameBivalirudin
    PubMed HealthBivalirudin (Injection)
    Drug ClassesAnticoagulant
    Drug LabelAngiomax is a specific and reversible direct thrombin inhibitor. The active substance is a synthetic, 20amino acid peptide. The chemical name is D-phenylalanyl-L-prolyl-L-arginyl-L-prolyl-glycyl-glycyl-glycyl-glycyl-L-asparagyl-glycyl-L-aspartyl-L-...
    Active IngredientBivalirudin
    Dosage FormInjectable
    Routeinjection
    Strength250mg
    Market StatusTentative Approval
    CompanyHospira

    4.2 Drug 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.

    FDA Label

    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.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Bivalirudin mediates an inhibitory action on thrombin by directly and specifically binding to both the catalytic site and anion-binding exosite of circulating and clot-bound thrombin. The action of bivalirudin is reversible because thrombin will slowly cleave the thrombin-bivalirudin bond which recovers the active site of thrombin.

    5.2 MeSH Pharmacological Classification

    Antithrombins

    Endogenous factors and drugs that directly inhibit the action of THROMBIN, usually by blocking its enzymatic activity. They are distinguished from INDIRECT THROMBIN INHIBITORS, such as HEPARIN, which act by enhancing the inhibitory effects of antithrombins. (See all compounds classified as Antithrombins.)

    5.3 FDA Pharmacological Classification
    5.3.1 Pharmacological Classes
    Direct Thrombin Inhibitor [EPC]; Thrombin Inhibitors [MoA]; Anti-coagulant [EPC]
    5.4 ATC Code

    B01AE06

    B - Blood and blood forming organs

    B01 - Antithrombotic agents

    B01A - Antithrombotic agents

    B01AE - Direct thrombin inhibitors

    B01AE06 - Bivalirudin

    5.5 Absorption, Distribution and Excretion

    Absorption

    Following intravenous administration, bivalirudin exhibits linear pharmacokinetics. The mean steady state concentration is 12.3 +/- 1.7mcg/mL after administration of an intravenous bolus of 1mg/kg followd by a 2.5mg/kg/hr intravenous infusion given over 4 hours.

    Route of Elimination

    Bivalirudin is cleared from plasma by a combination of renal mechanisms (20%) and proteolytic cleavage.

    Volume of Distribution

    0.2L/kg

    Clearance

    3.4 mL/min/kg [Normal renal function]

    3.4 mL/min/kg [mild renal function]

    2.7 mL/min/kg [moderate renal function]

    2.8 mL/min/kg [severe renal function]

    1 mL/min/kg [Dialysis-dependent patients]

    5.6 Metabolism/Metabolites

    80% proteolytic cleavage

    5.7 Biological Half-Life

    Normal renal function: 25 min (in normal conditions)

    Creatinine clearance 10-29mL/min: 57min

    Dialysis-dependant patients: 3.5h

    5.8 Mechanism of Action

    Inhibits the action of thrombin by binding both to its catalytic site and to its anion-binding exosite. Thrombin is a serine proteinase that plays a central role in the thrombotic process, acting to cleave fibrinogen into fibrin monomers and to activate Factor XIII to Factor XIIIa, allowing fibrin to develop a covalently cross-linked framework which stabilizes the thrombus; thrombin also activates Factors V and VIII, promoting further thrombin generation, and activates platelets, stimulating aggregation and granule release.

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    18-Jan-2021
    19-Aug-2024
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - SOLUTION;INTRAVENOUS - 250MG/50ML (5...DOSAGE - SOLUTION;INTRAVENOUS - 250MG/50ML (5MG/ML)

    USFDA APPLICATION NUMBER - 208374

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    DOSAGE - SOLUTION;INTRAVENOUS - 500MG/100ML (...DOSAGE - SOLUTION;INTRAVENOUS - 500MG/100ML (5MG/ML)

    USFDA APPLICATION NUMBER - 208374

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    DOSAGE - INJECTABLE;INTRAVENOUS - 250MG/VIAL

    USFDA APPLICATION NUMBER - 20873

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    ABOUT THIS PAGE

    Bivalirudin Manufacturers

    A Bivalirudin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bivalirudin, including repackagers and relabelers. The FDA regulates Bivalirudin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bivalirudin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Bivalirudin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Bivalirudin Suppliers

    A Bivalirudin supplier is an individual or a company that provides Bivalirudin active pharmaceutical ingredient (API) or Bivalirudin finished formulations upon request. The Bivalirudin suppliers may include Bivalirudin API manufacturers, exporters, distributors and traders.

    click here to find a list of Bivalirudin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Bivalirudin USDMF

    A Bivalirudin DMF (Drug Master File) is a document detailing the whole manufacturing process of Bivalirudin active pharmaceutical ingredient (API) in detail. Different forms of Bivalirudin DMFs exist exist since differing nations have different regulations, such as Bivalirudin USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Bivalirudin DMF submitted to regulatory agencies in the US is known as a USDMF. Bivalirudin USDMF includes data on Bivalirudin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bivalirudin USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Bivalirudin suppliers with USDMF on PharmaCompass.

    Bivalirudin WC

    A Bivalirudin written confirmation (Bivalirudin WC) is an official document issued by a regulatory agency to a Bivalirudin manufacturer, verifying that the manufacturing facility of a Bivalirudin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bivalirudin APIs or Bivalirudin finished pharmaceutical products to another nation, regulatory agencies frequently require a Bivalirudin WC (written confirmation) as part of the regulatory process.

    click here to find a list of Bivalirudin suppliers with Written Confirmation (WC) on PharmaCompass.

    Bivalirudin NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Bivalirudin as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Bivalirudin API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Bivalirudin as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Bivalirudin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bivalirudin NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Bivalirudin suppliers with NDC on PharmaCompass.

    Bivalirudin GMP

    Bivalirudin Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Bivalirudin GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Bivalirudin GMP manufacturer or Bivalirudin GMP API supplier for your needs.

    Bivalirudin CoA

    A Bivalirudin CoA (Certificate of Analysis) is a formal document that attests to Bivalirudin's compliance with Bivalirudin specifications and serves as a tool for batch-level quality control.

    Bivalirudin CoA mostly includes findings from lab analyses of a specific batch. For each Bivalirudin CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Bivalirudin may be tested according to a variety of international standards, such as European Pharmacopoeia (Bivalirudin EP), Bivalirudin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bivalirudin USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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