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    Orkambi

    FINISHED DOSAGE FORMULATIONS

    DIGITAL CONTENT

    GLOBAL SALES INFORMATION

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    2D Structure
    Also known as: Lumacaftor / ivacaftor, Lumacaftor and ivacaftor, Lumacaftor and ivacaftor tablet, Schembl19410545, Vx 700-vx 809 combination, Vx 809-vx 770 combination
    Molecular Formula
    C48H46F2N4O8
    Molecular Weight
    844.9  g/mol
    InChI Key
    YQCGOSZYHRVOFW-UHFFFAOYSA-N
    1 2D Structure

    2D Structure

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    N-(2,4-ditert-butyl-5-hydroxyphenyl)-4-oxo-1H-quinoline-3-carboxamide;3-[6-[[1-(2,2-difluoro-1,3-benzodioxol-5-yl)cyclopropanecarbonyl]amino]-3-methylpyridin-2-yl]benzoic acid
    2.1.2 InChI
    InChI=1S/C24H18F2N2O5.C24H28N2O3/c1-13-5-8-19(27-20(13)14-3-2-4-15(11-14)21(29)30)28-22(31)23(9-10-23)16-6-7-17-18(12-16)33-24(25,26)32-17;1-23(2,3)16-11-17(24(4,5)6)20(27)12-19(16)26-22(29)15-13-25-18-10-8-7-9-14(18)21(15)28/h2-8,11-12H,9-10H2,1H3,(H,29,30)(H,27,28,31);7-13,27H,1-6H3,(H,25,28)(H,26,29)
    2.1.3 InChI Key
    YQCGOSZYHRVOFW-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1=C(N=C(C=C1)NC(=O)C2(CC2)C3=CC4=C(C=C3)OC(O4)(F)F)C5=CC(=CC=C5)C(=O)O.CC(C)(C)C1=CC(=C(C=C1NC(=O)C2=CNC3=CC=CC=C3C2=O)O)C(C)(C)C
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Ivacaftor - Lumacaftor

    2. Ivacaftor, Lumacaftor Drug Combination

    3. Lumacaftor, Ivacaftor Drug Combination

    2.2.2 Depositor-Supplied Synonyms

    1. Lumacaftor / Ivacaftor

    2. Lumacaftor And Ivacaftor

    3. Lumacaftor And Ivacaftor Tablet

    4. Schembl19410545

    5. Vx 700-vx 809 Combination

    6. Vx 809-vx 770 Combination

    7. Ivacaftor Mixture With Lumacaftor

    8. Lumacaftor, Ivacaftor Drug Combination

    9. S900006790

    10. 1815566-23-4

    2.3 Create Date
    2013-06-10
    3 Chemical and Physical Properties
    Molecular Weight 844.9 g/mol
    Molecular Formula C48H46F2N4O8
    Hydrogen Bond Donor Count5
    Hydrogen Bond Acceptor Count12
    Rotatable Bond Count9
    Exact Mass844.32837076 g/mol
    Monoisotopic Mass844.32837076 g/mol
    Topological Polar Surface Area176 Ų
    Heavy Atom Count62
    Formal Charge0
    Complexity1450
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 1  
    Drug NameORKAMBI
    Active IngredientIVACAFTOR; LUMACAFTOR
    CompanyVERTEX PHARMS INC (Application Number: N206038. Patents: 7495103, 7973038, 8324242, 8410274, 8507534, 8653103, 8716338, 8741933, 8754224, 8846718, 8993600, 9150552, 9192606, 9216969, 9670163, 9931334)

    4.2 Drug Indication

    Orkambi tablets are indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who are homozygous for the F508del mutation in the CFTR gene.

    Orkambi granules are indicated for the treatment of cystic fibrosis (CF) in children aged 2 years and older who are homozygous for the F508del mutation in the CFTR gene.

    5 Pharmacology and Biochemistry
    5.1 FDA Pharmacological Classification
    5.1.1 Pharmacological Classes
    Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC]; Cytochrome P450 2B6 Inducers [MoA]; Cytochrome P450 2C19 Inducers [MoA]; Cytochrome P450 2C8 Inducers [MoA]; Cytochrome P450 2C8 Inhibitors [MoA]; Cytochrome P450 2C9 Inducers [MoA]; Cytochrome P450 2C9 Inhibitors [MoA]; Cytochrome P450 3A Inducers [MoA]; Cytochrome P450 3A Inhibitors [MoA]; P-Glycoprotein Inducers [MoA]; P-Glycoprotein Inhibitors [MoA]; Chloride Channel Activation Potentiators [MoA]
    5.2 ATC Code

    R07AX30