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    Also known as: 142340-99-6, Hepsera, Preveon, Adefovir pivoxil, Bis-pom pmea, Gs-0840
    Molecular Formula
    C20H32N5O8P
    Molecular Weight
    501.5  g/mol
    InChI Key
    WOZSCQDILHKSGG-UHFFFAOYSA-N
    FDA UNII
    U6Q8Z01514
    Adefovir Dipivoxil
    Adefovir Dipivoxil is a dipivoxil formulation of adefovir, a nucleoside reverse transcriptase inhibitor analog of adenosine with activity against hepatitis B virus (HBV), herpes virus, and human immunodeficiency virus (HIV).
    1 2D Structure

    Adefovir Dipivoxil

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [2-(6-aminopurin-9-yl)ethoxymethyl-(2,2-dimethylpropanoyloxymethoxy)phosphoryl]oxymethyl 2,2-dimethylpropanoate
    2.1.2 InChI
    InChI=1S/C20H32N5O8P/c1-19(2,3)17(26)30-11-32-34(28,33-12-31-18(27)20(4,5)6)13-29-8-7-25-10-24-14-15(21)22-9-23-16(14)25/h9-10H,7-8,11-13H2,1-6H3,(H2,21,22,23)
    2.1.3 InChI Key
    WOZSCQDILHKSGG-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC(C)(C)C(=O)OCOP(=O)(COCCN1C=NC2=C(N=CN=C21)N)OCOC(=O)C(C)(C)C
    2.2 Other Identifiers
    2.2.1 UNII
    U6Q8Z01514
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 9-(2-((-bis((pivaloyloxy)methoxy)phosphinyl)methoxy)ethyl)adenine

    2. Adefovir Depivoxil

    3. Gs 840

    4. Gs-0840

    5. Hepsera

    6. Preveon

    2.3.2 Depositor-Supplied Synonyms

    1. 142340-99-6

    2. Hepsera

    3. Preveon

    4. Adefovir Pivoxil

    5. Bis-pom Pmea

    6. Gs-0840

    7. Gs 0840

    8. Gs 840

    9. Gs-840

    10. [2-(6-aminopurin-9-yl)ethoxymethyl-(2,2-dimethylpropanoyloxymethoxy)phosphoryl]oxymethyl 2,2-dimethylpropanoate

    11. Adefovir Dipivoxil [usan]

    12. Adefovir Pivoxil (jan)

    13. Adefovir Di(pivaloyloxymethyl) Ester

    14. Adefovir Dipivoxil (usan)

    15. 9-(2-((bis((pivaloyloxy)methoxy)phosphinyl)methoxy)ethyl)adenine

    16. (((2-(6-amino-9h-purin-9-yl)ethoxy)methyl)phosphinylidene)bis(oxymethylene) 2,2-dimethylpropanoate

    17. ((2-(6-amino-9h-purin-9-yl)ethoxy)methyl)phosphonic Acid, Diester With Hydroxymethyl Pivalate

    18. Adefovir Dipivoxil (preveon, Hepsera)

    19. U6q8z01514

    20. Propanoic Acid, 2,2-dimethyl-, (((2-(6-amino-9h-purin-9-yl)ethoxy)methyl)phosphinylidene)bis(oxymethylene) Ester

    21. Ncgc00164624-01

    22. Adefovirdipivoxl

    23. Dsstox_cid_26487

    24. Dsstox_rid_81658

    25. Dsstox_gsid_46487

    26. ((((2-(6-amino-9h-purin-9-yl)ethoxy)methyl)phosphoryl)bis(oxy))bis(methylene) Bis(2,2-dimethylpropanoate)

    27. Adefovir Pivoxil [jan]

    28. 9-[2-[bis(pivaloyloxymethoxy)phosphorylmethoxy]ethyl]adenine

    29. Youheding

    30. Adefovir Dipivoxyl

    31. [({[2-(6-amino-9h-purin-9-yl)ethoxy]methyl}({[(2,2-dimethylpropanoyl)oxy]methoxy})phosphoryl)oxy]methyl 2,2-dimethylpropanoate

    32. Bis(pom)pmea

    33. Smr002530072

    34. Hepsera (tm)

    35. Hepsera (tn)

    36. Piv2pmea

    37. Cas-142340-99-6

    38. Bis(pom)-pmea

    39. 9-(2-((-bis((pivaloyloxy)methoxy)phosphinyl)methoxy)ethyl)adenine

    40. Unii-u6q8z01514

    41. Adefovir-dipivoxil

    42. Mfcd00869897

    43. Adefovir Dipivoxil- Bio-x

    44. Chembl922

    45. Schembl29729

    46. Mls003915635

    47. Mls004774124

    48. Dtxsid5046487

    49. Chebi:31175

    50. 9-(2[bis(pivaloyloxymethoxy)phosphorylmethoxy]ethyl)adenine

    51. Bis(pivaloyloxymethyl)-9-(2-phosphonylmethoxyethyl)adenine

    52. Adefovir Dipivoxil [vandf]

    53. Bcpp000434

    54. Hms3604f09

    55. Hms3655i04

    56. Adefovir Dipivoxil [mart.]

    57. Adefovir Dipivoxil [who-dd]

    58. Bcp22959

    59. Hy-b0255

    60. Zinc3930376

    61. Tox21_112243

    62. Bdbm50248359

    63. S1718

    64. Stl257088

    65. Adefovir Dipivoxil [ema Epar]

    66. Akos005145737

    67. Tox21_112243_1

    68. Ab07592

    69. Ac-1693

    70. Bcp9000232

    71. Ccg-269700

    72. Db00718

    73. Gs-3604

    74. Adefovir Dipivoxil [orange Book]

    75. Ncgc00164624-02

    76. Ncgc00164624-03

    77. Ncgc00164624-11

    78. Ba164139

    79. Bcp0726000157

    80. B2222

    81. Ft-0631164

    82. Sw219933-1

    83. D01655

    84. Ab01274706-01

    85. Ab01274706_02

    86. 340a996

    87. A807894

    88. Adefovir Di(pivaloyloxymethyl) Ester [mi]

    89. Adefovir Dipivoxil 100 Microg/ml In Acetonitrile

    90. Sr-01000931258

    91. Q-101927

    92. Sr-01000931258-2

    93. Brd-k96159438-001-03-0

    94. Adefovir Dipivoxil, Antibiotic For Culture Media Use Only

    95. Bis(pivaloyloxymethyl)-9-[2-(phosphonomethoxy)ethyl]adenine

    96. ((((2-(6-amino-9h-purin-9-yl)ethoxy)methyl)phosphoryl)-bis(oxy))bis(methylene) Bis(2,2-dimethylpropanoate)

    97. (((2-(6-amino-9h-purin-9-yl)ethoxy)methyl)phosphoryl)bis(oxy)bis(methylene) Bis(2,2-dimethylpropanoate)

    98. ({[2-(6-amino-9h-purin-9-yl)ethoxy]methyl}phosphoryl)bis(oxymethanediyl) Bis(2,2-dimethylpropanoate)

    99. 2,2-dimethylpropanoic Acid [2-(6-aminopurin-9-yl)ethoxymethyl-[(2,2-dimethyl-1-oxopropoxy)methoxy]phosphoryl]oxymethyl Ester;adefovir Dipivoxyl

    100. 3-{[2-(6-amino-9h-purin-9-yl)ethoxy]methyl}-8,8-dimethyl-3-oxido-7-oxo-2,4,6-trioxa-3?5-phosphanon-1-yl 2,2-dimethylpropanoate

    101. 3-{[2-(6-amino-9h-purin-9-yl)ethoxy]methyl}-8,8-dimethyl-3-oxido-7-oxo-2,4,6-trioxa-3lambda~5~-phosphanon-1-yl 2,2-dimethylpropanoate

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 501.5 g/mol
    Molecular Formula C20H32N5O8P
    XLogP31.8
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count12
    Rotatable Bond Count15
    Exact Mass501.19884999 g/mol
    Monoisotopic Mass501.19884999 g/mol
    Topological Polar Surface Area167 Ų
    Heavy Atom Count34
    Formal Charge0
    Complexity706
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    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 NameAdefovir dipivoxil
    PubMed HealthAdefovir Dipivoxil (By mouth)
    Drug ClassesAntiviral
    Drug LabelHEPSERA is the tradename for adefovir dipivoxil, a diester prodrug of adefovir. Adefovir is an acyclic nucleotide analog with activity against human hepatitis B virus (HBV). The chemical name of adefovir dipivoxil is 9-[2-[[bis[(pivaloyloxy)methoxy...
    Active IngredientAdefovir dipivoxil
    Dosage FormTablet
    RouteOral
    Strength10mg
    Market StatusPrescription
    CompanySigmapharm Labs

    2 of 4  
    Drug NameHepsera
    PubMed HealthAdefovir Dipivoxil (By mouth)
    Drug ClassesAntiviral
    Drug LabelHEPSERA is the tradename for adefovir dipivoxil, a diester prodrug of adefovir. Adefovir is an acyclic nucleotide analog with activity against human hepatitis B virus (HBV). The chemical name of adefovir dipivoxil is 9-[2-[[bis[(pivaloyloxy)methoxy...
    Active IngredientAdefovir dipivoxil
    Dosage FormTablet
    RouteOral
    Strength10mg
    Market StatusPrescription
    CompanyGilead

    3 of 4  
    Drug NameAdefovir dipivoxil
    PubMed HealthAdefovir Dipivoxil (By mouth)
    Drug ClassesAntiviral
    Drug LabelHEPSERA is the tradename for adefovir dipivoxil, a diester prodrug of adefovir. Adefovir is an acyclic nucleotide analog with activity against human hepatitis B virus (HBV). The chemical name of adefovir dipivoxil is 9-[2-[[bis[(pivaloyloxy)methoxy...
    Active IngredientAdefovir dipivoxil
    Dosage FormTablet
    RouteOral
    Strength10mg
    Market StatusPrescription
    CompanySigmapharm Labs

    4 of 4  
    Drug NameHepsera
    PubMed HealthAdefovir Dipivoxil (By mouth)
    Drug ClassesAntiviral
    Drug LabelHEPSERA is the tradename for adefovir dipivoxil, a diester prodrug of adefovir. Adefovir is an acyclic nucleotide analog with activity against human hepatitis B virus (HBV). The chemical name of adefovir dipivoxil is 9-[2-[[bis[(pivaloyloxy)methoxy...
    Active IngredientAdefovir dipivoxil
    Dosage FormTablet
    RouteOral
    Strength10mg
    Market StatusPrescription
    CompanyGilead

    4.2 Drug Indication

    Indicated for the treatment of chronic hepatitis B in adult patients with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease; this is based on histological, virological, biochemical, and serological responses in adult patients with HBeAg+ and HBeAg- chronic hepatitis B with compensated liver function, and in adult patients with clinical evidence of lamivudine-resistant hepatitis B virus with either compensated or decompensated liver function.

    FDA Label

    Hepsera is indicated for the treatment of chronic hepatitis B in adults with:

    - compensated liver disease with evidence of active viral replication, persistently elevated serum-alanine-aminotransferase (ALT) levels and histological evidence of active liver inflammation and fibrosis. Initiation of Hepsera treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate (see section 5. 1);

    - decompensated liver disease in combination with a second agent without cross-resistance to Hepsera.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Adefovir dipivoxil a diester prodrug of adefovir. Adefovir is an acyclic nucleotide analog with activity against human hepatitis B virus (HBV). The concentration of adefovir that inhibited 50% of viral DNA synthesis (IC50) in vitro ranged from 0.2 to 2.5 μM in HBV transfected human hepatoma cell lines. The combination of adefovir with lamivudine showed additive anti-HBV activity.

    5.2 MeSH Pharmacological Classification

    Antiviral Agents

    Agents used in the prophylaxis or therapy of VIRUS DISEASES. Some of the ways they may act include preventing viral replication by inhibiting viral DNA polymerase; binding to specific cell-surface receptors and inhibiting viral penetration or uncoating; inhibiting viral protein synthesis; or blocking late stages of virus assembly. (See all compounds classified as Antiviral Agents.)

    Reverse Transcriptase Inhibitors

    Inhibitors of reverse transcriptase (RNA-DIRECTED DNA POLYMERASE), an enzyme that synthesizes DNA on an RNA template. (See all compounds classified as Reverse Transcriptase Inhibitors.)

    5.3 FDA Pharmacological Classification
    5.3.1 Pharmacological Classes
    Nucleoside Analog [EXT]; Nucleoside Reverse Transcriptase Inhibitors [MoA]; Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
    5.4 ATC Code

    J05AF08

    J05AF08

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    J - Antiinfectives for systemic use

    J05 - Antivirals for systemic use

    J05A - Direct acting antivirals

    J05AF - Nucleoside and nucleotide reverse transcriptase inhibitors

    J05AF08 - Adefovir dipivoxil

    5.5 Absorption, Distribution and Excretion

    Absorption

    The approximate oral bioavailability of adefovir from HEPSERA is 59%. When a single oral 10 mg dose is given to chronic hepatitis B patients, the peak plasma concentration (Cmax) of adefovir was 18.4 6.26 ng/mL. This occurred between 0.58 - 4 hours post dose (Tmax). The adefovir area under the plasma concentration-time curve (AUC0) was 220 70.0 ngh/mL. Food does not affect the exposure of adeforvir.

    Route of Elimination

    Adefovir is renally excreted by a combination of glomerular filtration and active tubular secretion.

    Volume of Distribution

    392 75 mL/kg [Vd at steady state, intravenous administration of 1.0 mg/kg/day]

    352 9 mL/kg [Vd at steady state, intravenous administration of 3.0 mg/kg/day]

    Clearance

    469 99.0 mL/min [Patients with Unimpaired renal Function receiving a 10 mg single dose]

    356 85.6 mL/min [Patients with mild renal impairement receiving a 10 mg single dose]

    237 118 mL/min [Patients with moderate renal impairement receiving a 10 mg single dose]

    91.7 51.3 mL/min [Patients with severe renal impairement receiving a 10 mg single dose]

    5.6 Metabolism/Metabolites

    Following oral administration, adefovir dipivoxil is rapidly converted to adefovir. 45% of the dose is recovered as adefovir in the urine over 24 hours at steady state following 10 mg oral doses. Adefovir is not a substrate of the cytochrome P450 enzymes.

    5.7 Biological Half-Life

    Plasma adefovir concentrations declined in a biexponential manner with a terminal elimination half-life of 7.48 1.65 hours.

    5.8 Mechanism of Action

    Adefovir dipivoxil is a prodrug of adefovir. Adefovir is an acyclic nucleotide analog of adenosine monophosphate which is phosphorylated to the active metabolite adefovir diphosphate by cellular kinases. Adefovir diphosphate inhibits HBV DNA polymerase (reverse transcriptase) by competing with the natural substrate deoxyadenosine triphosphate and by causing DNA chain termination after its incorporation into viral DNA. The inhibition constant (Ki) for adefovir diphosphate for HBV DNA polymerase was 0.1 μM. Adefovir diphosphate is a weak inhibitor of human DNA polymerases α and γ with Ki values of 1.18 μM and 0.97μM, respectively.

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    ABOUT THIS PAGE

    Adefovir Dipivoxil Manufacturers

    A Adefovir Dipivoxil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Adefovir Dipivoxil, including repackagers and relabelers. The FDA regulates Adefovir Dipivoxil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Adefovir Dipivoxil 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 Adefovir Dipivoxil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Adefovir Dipivoxil Suppliers

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

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

    Adefovir Dipivoxil USDMF

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

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

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

    Adefovir Dipivoxil KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Adefovir Dipivoxil Drug Master File in Korea (Adefovir Dipivoxil KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Adefovir Dipivoxil. The MFDS reviews the Adefovir Dipivoxil KDMF as part of the drug registration process and uses the information provided in the Adefovir Dipivoxil KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Adefovir Dipivoxil KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Adefovir Dipivoxil API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Adefovir Dipivoxil suppliers with KDMF on PharmaCompass.

    Adefovir Dipivoxil WC

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

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

    Adefovir Dipivoxil 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 Adefovir Dipivoxil as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Adefovir Dipivoxil 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 Adefovir Dipivoxil 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 Adefovir Dipivoxil and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Adefovir Dipivoxil NDC to their finished compounded human drug products, they may choose to do so.

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

    Adefovir Dipivoxil GMP

    Adefovir Dipivoxil 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 Adefovir Dipivoxil 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 Adefovir Dipivoxil GMP manufacturer or Adefovir Dipivoxil GMP API supplier for your needs.

    Adefovir Dipivoxil CoA

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

    Adefovir Dipivoxil CoA mostly includes findings from lab analyses of a specific batch. For each Adefovir Dipivoxil 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.

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