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Darifenacin

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

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DRUG PRODUCT COMPOSITION

TABLET, EXTENDED RELEASE;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

Suppliers, 31 Kerry, 10 Microlex e.U, 10 Sigachi Industries, 10 Corel Pharma Chem, 9 BASF, 9 Roquette, 8 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 7 Gangwal Healthcare, 6 Lonza Capsugel, 6 Seppic, 5 Nanjing Well Pharmaceutical, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 DFE Pharma, 3 Actylis, 3 Clariant, 3 Kima Chemical, 2 The Dow Chemical Company, 2 Prachin Chemical, 2 Seqens, 2 Vasa Pharmachem, 2 Nomisma Healthcare, 2 Boai NKY Pharmaceuticals Ltd, 1 Finar, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Ulanqab Kema New Material, 1 Avesta Pharma, 1 ACG Worldwide, 1 Qualicaps, 1 Pharmatrans-Sanaq, 1 DKSH, 1 SPI Pharma, 1 Aeon Procare

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1 BioAnalytical Methods, 3 USP Standards, 4 Other Ref. Standards

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Also known as: Darifenacin hbr, 133099-07-7, Emselex, Darifenacin (hydrobromide), Darifenacin hydrobromide [usan], Cr02eyq8gv

Molecular Formula

C₂₈H₃₁BrN₂O₂

Molecular Weight

507.5 g/mol

InChI Key

UQAVIASOPREUIT-VQIWEWKSSA-N

FDA UNII

CR02EYQ8GV

1 2D Structure

Darifenacin

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2-[(3S)-1-[2-(2,3-dihydro-1-benzofuran-5-yl)ethyl]pyrrolidin-3-yl]-2,2-diphenylacetamide;hydrobromide

2.1.2 InChI

InChI=1S/C28H30N2O2.BrH/c29-27(31)28(23-7-3-1-4-8-23,24-9-5-2-6-10-24)25-14-17-30(20-25)16-13-21-11-12-26-22(19-21)15-18-32-26;/h1-12,19,25H,13-18,20H2,(H2,29,31);1H/t25-;/m1./s1

2.1.3 InChI Key

UQAVIASOPREUIT-VQIWEWKSSA-N

2.1.4 Canonical SMILES

C1CN(CC1C(C2=CC=CC=C2)(C3=CC=CC=C3)C(=O)N)CCC4=CC5=C(C=C4)OCC5.Br

2.1.5 Isomeric SMILES

C1CN(C[C@@H]1C(C2=CC=CC=C2)(C3=CC=CC=C3)C(=O)N)CCC4=CC5=C(C=C4)OCC5.Br

2.2 Other Identifiers

2.2.1 UNII

CR02EYQ8GV

2.3 Synonyms

2.3.1 MeSH Synonyms

1. (s)-1-(2-(2,3-dihydro-5-benzofuranyl)ethyl)-alpha,alpha-diphenyl-3-pyrrolidineacetamide

2. Darifenacin

3. Darifenacin Hydrochloride

4. Darifenacine

5. Darifenicin

6. Emselex

7. Enablex

8. Uk-88525

2.3.2 Depositor-Supplied Synonyms

1. Darifenacin Hbr

2. 133099-07-7

3. Emselex

4. Darifenacin (hydrobromide)

5. Darifenacin Hydrobromide [usan]

6. Cr02eyq8gv

7. 2-[(3s)-1-[2-(2,3-dihydro-1-benzofuran-5-yl)ethyl]pyrrolidin-3-yl]-2,2-diphenylacetamide Hydrobromide

8. Uk-88525-04 (hydrobromide)

9. Chebi:31455

10. Uk-88525-04 (hbr)

11. (s)-2-(1-(2-(2,3-dihydrobenzofuran-5-yl)ethyl)pyrrolidin-3-yl)-2,2-diphenylacetamide Hydrobromide

12. 133099-07-7 (hbr)

13. Dsstox_cid_26780

14. Dsstox_rid_81899

15. Dsstox_gsid_46780

16. (s)-2-{1-(2-(2,3-dihydrobenzofuran-5-yl)ethyl)-3-pyrrolidnyl}-2,2-diphenylacetamide Hydrobromide

17. Uk-88525

18. Darilong

19. 2-[(3s)-1-[2-(2,3-dihydro-1-benzofuran-5-yl)ethyl]pyrrolidin-3-yl]-2,2-diphenylacetamide;hydrobromide

20. Uk 88525-04 Hydrobromide

21. Cas-133099-07-7

22. Ncgc00168775-01

23. Unii-cr02eyq8gv

24. (s)-2-(1-(2-(2,3-dihydrobenzofuran-5-yl)ethyl)-3-pyrrolidnyl)-2,2-diphenylacetamide Hydrobromide

25. 2-{(3s)-1-[2-(2,3-dihydro-1-benzofuran-5-yl)ethyl]pyrrolidin-3-yl}-2,2-diphenylacetamide Hydrobromide

26. Enablex (tn)

27. Darifenacinhydrobromide

28. Diphenyl-acetamide Hydrobromide

29. Darifenacin Hydrobromide- Bio-x

30. Chembl1200935

31. Dtxsid9046780

32. Hy-a0012

33. Tox21_112636

34. Darifenacin Hydrobromide (jan/usan)

35. Darifenacin Hydrobromide [mi]

36. Mfcd08141803

37. S3144

38. Darifenacin Hydrobromide [jan]

39. Akos015969311

40. Tox21_112636_1

41. Ac-1894

42. Ccg-220969

43. Cs-0380

44. Darifenacin Hydrobromide [mart.]

45. Darifenacin Hydrobromide [usp-rs]

46. Darifenacin Hydrobromide [who-dd]

47. Ncgc00263922-02

48. 3-pyrrolidineacetamide, 1-(2-(2,3-dihydro-5-benzofuranyl)ethyl)-alpha,alpha-diphenyl-, Monohydrobromide, (3s)-

49. 3-pyrrolidineacetamide, 1-(2-(2,3-dihydro-5-benzofuranyl)ethyl)-alpha,alpha-diphenyl-, Monohydrobromide, (s)-

50. 3-pyrrolidineacetamide, 1-[2-(2,3-dihydro-5-benzofuranyl)ethyl]-alpha,alpha-diphenyl-, Hydrobromide (1:1), (3s)-

51. As-35087

52. Bd164350

53. Darifenacin Hydrobromide [ema Epar]

54. Darifenacin Hydrobromide, >=98% (hplc)

55. Sw219426-1

56. Darifenacin Hydrobromide [orange Book]

57. Uk-88525-04

58. D01699

59. Q-101006

60. Q27114313

61. Z1691545283

62. Darifenacin Hydrobromide, United States Pharmacopeia (usp) Reference Standard

63. (s)-2-(1-(2-(2,3-dihydrobenzofuran-5-yl)ethyl)-3-pyrrolidnyl)-2,2-diphenylacetamide Hbr

64. 3-pyrrolidineacetamide, 1-(2-(2,3-dihydro-5-benzofuranyl)ethyl)-.alpha.,.alpha.-diphenyl-, Monohbr, (3s)-

65. 3-pyrrolidineacetamide, 1-(2-(2,3-dihydro-5-benzofuranyl)ethyl)-.alpha.,.alpha.-diphenyl-, Monohydrobromide, (3s)-

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₂₈H₃₁BrN₂O₂
Molecular Weight	507.5 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	7
Exact Mass	506.15689 g/mol
Monoisotopic Mass	506.15689 g/mol
Topological Polar Surface Area	55.6 Å²
Heavy Atom Count	33
Formal Charge	0
Complexity	607
Isotope Atom Count	0
Defined Atom Stereocenter Count	1
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Darifenacin hydrobromide
Active Ingredient	Darifenacin hydrobromide
Dosage Form	Tablet, extended release
Route	oral
Strength	7.5mg; 15mg
Market Status	Tentative Approval
Company	Anchen Pharms

2 of 4
Drug Name	Enablex
PubMed Health	Darifenacin (By mouth)
Drug Classes	Urinary Antispasmodic
Drug Label	ENABLEX (darifenacin) is an extended-release tablet which contains 7.5mg or 15mg darifenacin as its hydrobromide salt. The active moiety, darifenacin, is a potent muscarinic receptor antagonist.Chemically, darifenacin hydrobromide is (S)-2-{1-[...
Active Ingredient	Darifenacin hydrobromide
Dosage Form	Tablet, extended release
Route	Oral
Strength	eq 15mg base; eq 7.5mg base
Market Status	Prescription
Company	Warner Chilcott

3 of 4
Drug Name	Darifenacin hydrobromide
Active Ingredient	Darifenacin hydrobromide
Dosage Form	Tablet, extended release
Route	oral
Strength	7.5mg; 15mg
Market Status	Tentative Approval
Company	Anchen Pharms

4 of 4
Drug Name	Enablex
PubMed Health	Darifenacin (By mouth)
Drug Classes	Urinary Antispasmodic
Drug Label	ENABLEX (darifenacin) is an extended-release tablet which contains 7.5mg or 15mg darifenacin as its hydrobromide salt. The active moiety, darifenacin, is a potent muscarinic receptor antagonist.Chemically, darifenacin hydrobromide is (S)-2-{1-[...
Active Ingredient	Darifenacin hydrobromide
Dosage Form	Tablet, extended release
Route	Oral
Strength	eq 15mg base; eq 7.5mg base
Market Status	Prescription
Company	Warner Chilcott

4.2 Drug Indication

Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult 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 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Cholinergic Muscarinic Antagonists [MoA]; Cholinergic Muscarinic Antagonist [EPC]

5.3 ATC Code

G04BD10