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ACTIVE PHARMA INGREDIENTS

24 API Suppliers, 15 USDMF, 6 EU WC, 5 KDMF, 7 NDC API, 13 Listed Suppliers, $ API Reference Price

24 API Suppliers
15 USDMF
6 EU WC
5 KDMF
7 NDC API
13 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

4 Intermediates Suppliers

4 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

93 FDF Dossiers, 30 FDA Orange Book, 45 Europe, 4 Canada, 14 Listed Dossiers

93 FDF Dossiers
30 FDA Orange Book
45 Europe
4 Canada
14 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 4MG, TABLET, EXTENDED RELEASE;ORAL - 8MG

drugProductComposition
TABLET, EXTENDED RELEASE;ORAL - 4MG
TABLET, EXTENDED RELEASE;ORAL - 8MG

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 4 SPI Pharma, 2 Seqens, 4 DKSH, 1 Pharm-RX Chemical, 4 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 11 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 4 Actylis, 1 Aeon Procare, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 18 BASF, 10 Corel Pharma Chem, 4 DFE Pharma, 1 Finar, 7 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 31 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 2 Nomisma Healthcare, 3 Novo Excipients, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 15 Roquette, 7 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 2 The Dow Chemical Company, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

63 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 32 Controlled & Modified Release, 28 Direct Compression, 20 Thickeners and Stabilizers, 17 Granulation, 14 Co-Processed Excipients, 12 Lubricants & Glidants, 12 Disintegrants & Superdisintegrants, 12 Solubilizers, 11 Topical, 9 Taste Masking, 8 Film Formers & Plasticizers, 7 Chewable & Orodispersible Aids, 7 Parenteral, 5 Empty Capsules, 5 API Stability Enhancers, 4 Rheology Modifiers, 4 Vegetarian Capsules, 4 Coloring Agents, 3 Emulsifying Agents

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 21 NEWS #PharmaBuzz

media
1 DATA COMPILATION #PharmaFlow
21 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 45 Finished Drug Prices, 9 Annual Reports

globalSalesInformation
1 US Medicaid Prescriptions
45 Finished Drug Prices
9 Annual Reports

MARKET PLACE

3 APIs, 1 Intermediates

marketPlace
3 APIs
1 Intermediates

PATENTS & EXCLUSIVITIES

12 US Patents, 4 US Exclusivities, 8 Health Canada Patents

patents
12 US Patents
4 US Exclusivities
8 Health Canada Patents

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 6,039

MARKET PLACE

API

FDF

4INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

2DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

107,715,372

Annual Reports (USD Million)

1,982

Finished Drug Prices

197 RELATED EXCIPIENT COMPANIES

328EXCIPIENTS BY APPLICATIONS

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 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 Formula	C₃₀H₄₁NO₇
Molecular Weight	527.6 g/mol
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	8
Rotatable Bond Count	13
Exact Mass	527.28830265 g/mol
Monoisotopic Mass	527.28830265 g/mol
Topological Polar Surface Area	124 Å²
Heavy Atom Count	38
Formal Charge	0
Complexity	610
Isotope Atom Count	0
Defined Atom Stereocenter Count	1
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	1
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Toviaz
PubMed Health	Fesoterodine (By mouth)
Drug Classes	Urinary Antispasmodic
Drug Label	Toviaz 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 Ingredient	Fesoterodine fumarate
Dosage Form	Tablet, extended release
Route	Oral
Strength	8mg; 4mg
Market Status	Prescription
Company	Pfizer

2 of 2
Drug Name	Toviaz
PubMed Health	Fesoterodine (By mouth)
Drug Classes	Urinary Antispasmodic
Drug Label	Toviaz 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 Ingredient	Fesoterodine fumarate
Dosage Form	Tablet, extended release
Route	Oral
Strength	8mg; 4mg
Market Status	Prescription
Company	Pfizer

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

API SUPPLIERS

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USDMF

01

Alembic Pharmaceuticals Ltd

India

AES 2024

Not Confirmed

02

Signa Sa De Cv

Canada

AES 2024

Not Confirmed

03

Chemi Spa

Italy

India

AES 2024

Not Confirmed

10

Sun Pharmaceutical Industries Ltd

India

AES 2024

Not Confirmed

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EU WC

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KDMF

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NDC API

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Listed Suppliers

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API Reference Price

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REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"5.50","actualQuantity":"5.5","unit":"KGS","unitRateFc":"12000","totalValueFC":"72104","currency":"EUR","unitRateINR":"1094400","date":"29-Jun-2024","totalValueINR":"6019200","totalValueInUsd":"72104","indian_port":"Hyderabad Air","hs_no":"29225090","bill_no":"4254820","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"MALTA","supplierAddress":"Via Bissone, 5 20021 Baranzate (MI)? Italy Italy ItalySDNF Italy","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 4MG

USFDA APPLICATION NUMBER - 22030

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG

USFDA APPLICATION NUMBER - 22030

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Granulation

Co-Processed Excipients

Lubricants & Glidants

Disintegrants & Superdisintegrants

Solubilizers

Topical

Taste Masking

Film Formers & Plasticizers

Chewable & Orodispersible Aids

Parenteral

Empty Capsules

API Stability Enhancers

Rheology Modifiers

Vegetarian Capsules

Coloring Agents

Emulsifying Agents

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US Medicaid Prescriptions

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Finished Drug Prices

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INTERMEDIATES

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

24 API Suppliers

15 USDMF

6 EU WC

5 KDMF

7 NDC API

13 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

INTERMEDIATES

4 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

93 FDF Dossiers

30 FDA Orange Book

45 Europe

4 Canada

14 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 4MG

TABLET, EXTENDED RELEASE;ORAL - 8MG

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EXCIPIENTS BY APPLICATIONS

63 Fillers, Diluents & Binders

51 Coating Systems & Additives

32 Controlled & Modified Release

28 Direct Compression

20 Thickeners and Stabilizers

17 Granulation

14 Co-Processed Excipients

12 Lubricants & Glidants

12 Disintegrants & Superdisintegrants

12 Solubilizers

11 Topical

9 Taste Masking

8 Film Formers & Plasticizers

7 Chewable & Orodispersible Aids