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    Chemistry

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    Also known as: 286930-03-8, Toviaz, (r)-fesoterodine fumarate, Spm 907, Spm 8272, Spm-907
    Molecular Formula
    C30H41NO7
    Molecular Weight
    527.6  g/mol
    InChI Key
    MWHXMIASLKXGBU-RNCYCKTQSA-N
    FDA UNII
    EOS72165S7
    Fesoterodine
    Fesoterodine Fumarate is the fumarate salt form of fesoterodine, a competitive muscarinic receptor antagonist with muscle relaxant and urinary antispasmodic properties. Fesoterodine is rapidly hydrolyzed in vivo into its active metabolite 5-hydroxy methyl tolterodine, which binds and inhibits muscarinic receptors on the bladder detrusor muscle, thereby preventing bladder contractions or spasms caused by acetylcholine. This results in the relaxation of bladder smooth muscle and greater bladder capacity, in addition to a reduction in involuntary muscle contractions and involuntary loss of urine. The active metabolite does not interact with alpha-adrenergic, serotonergic, histaminergic and excitatory amino acid receptors and is eliminated via renal excretion.
    1 2D Structure

    Fesoterodine

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (E)-but-2-enedioic acid;[2-[(1R)-3-[di(propan-2-yl)amino]-1-phenylpropyl]-4-(hydroxymethyl)phenyl] 2-methylpropanoate
    2.1.2 InChI
    InChI=1S/C26H37NO3.C4H4O4/c1-18(2)26(29)30-25-13-12-21(17-28)16-24(25)23(22-10-8-7-9-11-22)14-15-27(19(3)4)20(5)6;5-3(6)1-2-4(7)8/h7-13,16,18-20,23,28H,14-15,17H2,1-6H3;1-2H,(H,5,6)(H,7,8)/b;2-1+/t23-;/m1./s1
    2.1.3 InChI Key
    MWHXMIASLKXGBU-RNCYCKTQSA-N
    2.1.4 Canonical SMILES
    CC(C)C(=O)OC1=C(C=C(C=C1)CO)C(CCN(C(C)C)C(C)C)C2=CC=CC=C2.C(=CC(=O)O)C(=O)O
    2.1.5 Isomeric SMILES
    CC(C)C(=O)OC1=C(C=C(C=C1)CO)[C@H](CCN(C(C)C)C(C)C)C2=CC=CC=C2.C(=C/C(=O)O)\C(=O)O
    2.2 Other Identifiers
    2.2.1 UNII
    EOS72165S7
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Fesoterodine

    2. Toviaz

    2.3.2 Depositor-Supplied Synonyms

    1. 286930-03-8

    2. Toviaz

    3. (r)-fesoterodine Fumarate

    4. Spm 907

    5. Spm 8272

    6. Spm-907

    7. Spm-8272

    8. Fesoterodine Maleate

    9. Fesoterodine (fumarate)

    10. Eos72165s7

    11. (e)-but-2-enedioic Acid;[2-[(1r)-3-[di(propan-2-yl)amino]-1-phenylpropyl]-4-(hydroxymethyl)phenyl] 2-methylpropanoate

    12. Propanoic Acid, 2-methyl-, 2-[(1r)-3-[bis(1-methylethyl)amino]-1-phenylpropyl]-4-(hydroxymethyl)phenyl Ester, (2e)-2-butenedioate (1:1)

    13. 286930-03-8 (fumarate); 286930-02-7 (free Base)

    14. Fesoterodine Fumarate [usan]

    15. Unii-eos72165s7

    16. Fesoterodine Fumarate [usan:jan]

    17. (e)-but-2-enedioic Acid,[2-[(1r)-3-[di(propan-2-yl)amino]-1-phenylpropyl]-4-(hydroxymethyl)phenyl] 2-methylpropanoate

    18. Toviaz (tn)

    19. (r)-fesoterodinefumarate

    20. Mls003915638

    21. Schembl814971

    22. Fesoterodine Fumarate - Toviaz

    23. Schembl1993632

    24. Chembl1201765

    25. Dtxsid00904655

    26. Bcpp000231

    27. Fesoterodine Fumarate (jan/usan)

    28. Fesoterodine Fumarate [mi]

    29. Hms3884d11

    30. Fesoterodine Fumarate [jan]

    31. Amy37611

    32. Hy-a0030

    33. Bdbm50248002

    34. Fesoterodine Fumarate [vandf]

    35. Mfcd12756004

    36. S2240

    37. Fesoterodine Fumarate [mart.]

    38. Akos005146248

    39. Akos015855886

    40. Fesoterodine Fumarate [who-dd]

    41. Ac-3486

    42. Bcp9000682

    43. Ccg-269901

    44. Cs-0822

    45. Ks-1298

    46. 2-((1r)-3-(diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl Isobutyrate

    47. Fesoterodine Fumarate [ema Epar]

    48. 2-((1r)-3-(bis(1-methylethyl)amino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl 2-methylpropanoate Hydrogen (2e)-butenedioate (salt)

    49. Propanoic Acid, 2-methyl-, 2-((1r)-3-(bis(1-methylethyl)amino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl Ester, (2e)-2-butenedioate (1:1) (salt)

    50. Smr002544691

    51. Fesoterodine Fumarate [orange Book]

    52. Pf-00695838

    53. D08923

    54. 930f038

    55. A846296

    56. Q27277274

    57. 2-((1r)-3-(bis(1-methylethyl)amino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl 2-methylpropanoate Hydrogen(2e)-butenedioate (salt)

    58. Fesoterodinefumarate;(r)-fesoterodine Fumarate;2-methylpropanoic Acid 2-[(1r)-3-[bis(1-methylethyl)amino]-1-phenylpropyl]-4-(hydroxymethyl)phenyl Ester (2e)-2-butenedioate

    59. Propanoic Acid,2-methyl ,2-((1r)-3-(bis(1-methylethyl)amino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl Ester,(2e)-2-butenedioate (1:1)(salt)

    2.4 Create Date
    2006-10-25
    3 Chemical and Physical Properties
    Molecular Weight 527.6 g/mol
    Molecular Formula C30H41NO7
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count13
    Exact Mass527.28830265 g/mol
    Monoisotopic Mass527.28830265 g/mol
    Topological Polar Surface Area124 Ų
    Heavy Atom Count38
    Formal Charge0
    Complexity610
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameToviaz
    PubMed HealthFesoterodine (By mouth)
    Drug ClassesUrinary Antispasmodic
    Drug LabelToviaz contains fesoterodine fumarate and is an extended-release tablet. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethyl-phenol, or 5-hydroxymethyl tolterodine, which is a musca...
    Active IngredientFesoterodine fumarate
    Dosage FormTablet, extended release
    RouteOral
    Strength8mg; 4mg
    Market StatusPrescription
    CompanyPfizer

    2 of 2  
    Drug NameToviaz
    PubMed HealthFesoterodine (By mouth)
    Drug ClassesUrinary Antispasmodic
    Drug LabelToviaz contains fesoterodine fumarate and is an extended-release tablet. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethyl-phenol, or 5-hydroxymethyl tolterodine, which is a musca...
    Active IngredientFesoterodine fumarate
    Dosage FormTablet, extended release
    RouteOral
    Strength8mg; 4mg
    Market StatusPrescription
    CompanyPfizer

    4.2 Drug Indication

    Treatment of the symptoms (increased urinary frequency and / or urgency and / or urgency incontinence) that may occur in patients with overactive-bladder syndrome.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Muscarinic Antagonists

    Drugs that bind to but do not activate MUSCARINIC RECEPTORS, thereby blocking the actions of endogenous ACETYLCHOLINE or exogenous agonists. Muscarinic antagonists have widespread effects including actions on the iris and ciliary muscle of the eye, the heart and blood vessels, secretions of the respiratory tract, GI system, and salivary glands, GI motility, urinary bladder tone, and the central nervous system. (See all compounds classified as Muscarinic Antagonists.)

    Urological Agents

    Drugs used in the treatment of urological conditions and diseases such as URINARY INCONTINENCE and URINARY TRACT INFECTIONS. (See all compounds classified as Urological Agents.)

    5.2 ATC Code

    G04BD11

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    ABOUT THIS PAGE

    Fesoterodine Manufacturers

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

    Fesoterodine Suppliers

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

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

    Fesoterodine USDMF

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

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

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

    Fesoterodine KDMF

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

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

    After submitting a Fesoterodine 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 Fesoterodine API can apply through the Korea Drug Master File (KDMF).

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

    Fesoterodine WC

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

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

    Fesoterodine 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 Fesoterodine as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Fesoterodine GMP

    Fesoterodine 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 Fesoterodine 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 Fesoterodine GMP manufacturer or Fesoterodine GMP API supplier for your needs.

    Fesoterodine CoA

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

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

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