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Fingolimod Hydrochloride

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ACTIVE PHARMA INGREDIENTS

48 API Suppliers, 20 USDMF, 15 CEP/COS, 1 JDMF, 13 EU WC, 15 NDC API, 31 Listed Suppliers, $ API Reference Price

48 API Suppliers
20 USDMF
15 CEP/COS
1 JDMF
13 EU WC
15 NDC API
31 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

12 Drugs in Development

12 Drugs in Development

INTERMEDIATES

5 Intermediates Suppliers

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

74 FDF Dossiers, 25 FDA Orange Book, 16 Europe, 10 Canada, 9 Australia, 4 South Africa, 10 Listed Dossiers

74 FDF Dossiers
25 FDA Orange Book
16 Europe
10 Canada
9 Australia
4 South Africa
10 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 12 SPI Pharma, 6 DKSH, 2 Faran Shimi Pharmaceutical, 1 Gangwal Healthcare, 1 Pfanstiehl, 4 ACG Worldwide, 1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 BASF, 3 Gangwal Chemicals, 1 Ingredion Pharma Solutions, 2 Kerry, 3 Lonza Capsugel, 7 Microlex e.U, 2 Pluviaendo, 1 Prachin Chemical, 1 Qualicaps, 5 Roquette, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Sigachi Industries, 1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

26 Fillers, Diluents & Binders, 10 Chewable & Orodispersible Aids, 10 Taste Masking, 10 Direct Compression, 8 Empty Capsules, 8 Lubricants & Glidants, 6 Thickeners and Stabilizers, 5 Co-Processed Excipients, 5 Coating Systems & Additives, 4 Parenteral, 3 Disintegrants & Superdisintegrants, 3 Granulation, 2 Coloring Agents, 2 Film Formers & Plasticizers, 1 Emulsifying Agents, 1 API Stability Enhancers, 1 Controlled & Modified Release

excipientsByApplications
26 Fillers, Diluents & Binders
10 Chewable & Orodispersible Aids
10 Taste Masking
10 Direct Compression
8 Empty Capsules
8 Lubricants & Glidants
6 Thickeners and Stabilizers
5 Co-Processed Excipients
5 Coating Systems & Additives
4 Parenteral
3 Disintegrants & Superdisintegrants
3 Granulation
2 Coloring Agents
2 Film Formers & Plasticizers
1 Emulsifying Agents
1 API Stability Enhancers
1 Controlled & Modified Release

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 143 NEWS #PharmaBuzz

media
1 DATA COMPILATION #PharmaFlow
143 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 13 Finished Drug Prices, 22 Annual Reports

globalSalesInformation
2 US Medicaid Prescriptions
13 Finished Drug Prices
22 Annual Reports

MARKET PLACE

5 APIs, 8 FDF Dossiers

marketPlace
5 APIs
8 FDF Dossiers

PATENTS & EXCLUSIVITIES

13 US Patents, 3 Health Canada Patents

patents
13 US Patents
3 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 USP , 13 Others

otherSolutions
1 USP
13 Others

ANALYTICAL

1 BioAnalytical Methods

otherMethods
1 BioAnalytical Methods

Synnat Fingolimod Hydrochloride

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 164,018

MARKET PLACE

API

FDF

5INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

12DRUGS 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

143

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

381,751,038

Annual Reports (USD Million)

27,329

Finished Drug Prices

59 RELATED EXCIPIENT COMPANIES

105EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 162359-56-0, Fty720, Fingolimod hcl, Gilenia, Gilenya, Fty 720

Molecular Formula

C₁₉H₃₄ClNO₂

Molecular Weight

343.9 g/mol

InChI Key

SWZTYAVBMYWFGS-UHFFFAOYSA-N

FDA UNII

G926EC510T

A sphingosine-derivative and IMMUNOSUPPRESSIVE AGENT that blocks the migration and homing of LYMPHOCYTES to the CENTRAL NERVOUS SYSTEM through its action on SPHINGOSINE 1-PHOSPHATE RECEPTORS. It is used in the treatment of MULTIPLE SCLEROSIS.

1 2D Structure

Fingolimod Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol;hydrochloride

2.1.2 InChI

InChI=1S/C19H33NO2.ClH/c1-2-3-4-5-6-7-8-17-9-11-18(12-10-17)13-14-19(20,15-21)16-22;/h9-12,21-22H,2-8,13-16,20H2,1H3;1H

2.1.3 InChI Key

SWZTYAVBMYWFGS-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CCCCCCCCC1=CC=C(C=C1)CCC(CO)(CO)N.Cl

2.2 Other Identifiers

2.2.1 UNII

G926EC510T

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 2-amino-2-(2-(4-octylphenyl)ethyl)-1,3-propanediol Hydrochloride

2. Fingolimod

3. Fty 720

4. Fty-720

5. Fty720

6. Gilenia

7. Gilenya

2.3.2 Depositor-Supplied Synonyms

1. 162359-56-0

2. Fty720

3. Fingolimod Hcl

4. Gilenia

5. Gilenya

6. Fty 720

7. Fty-720

8. Fingolimod (hydrochloride)

9. Fingolimod (fty720) Hcl

10. 2-amino-2-(4-octylphenethyl)propane-1,3-diol Hydrochloride

11. Fingolimod, Hcl

12. Fty720 Hydrochloride

13. Fingolimod Hydrochloride [usan]

14. 2-amino-2-(2-(4-octylphenyl)ethyl)-1,3-propanediol Hydrochloride

15. Fty720 Free Base

16. Chebi:63112

17. Fingolimod Hydrochlorid

18. 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol;hydrochloride

19. Fingolimod (as Hydrochloride)

20. Fty-720 Hydrochloride

21. 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol Hydrochloride

22. G926ec510t

23. Mfcd00939512

24. 2-amino-2-(2-(4-octylphenyl)ethyl)propane-1,3-diol Hydrochloride

25. Gilenya (tn)

26. 1,3-propanediol, 2-amino-2-(2-(4-octylphenyl)ethyl)-, Hydrochloride

27. 1,3-propanediol, 2-amino-2-[2-(4-octylphenyl)ethyl]-, Hydrochloride

28. 2-amino-2-[2-(4-octylphenyl)ethyl]-1,3-propanediol, Hydrochloride

29. Fty-720a

30. Fingolimod (fty720)

31. Imusera

32. Unii-g926ec510t

33. 2-amino-2-[2-(4-octylphenyl)ethyl]-1,3-propanediol Hydrochloride

34. Fty720,fingolimod

35. Fingolimodhydrochloride

36. Fin;limod Hydrochloride

37. Fty720 - Fingolimod

38. Fingolimod Hclfty-720

39. Epitope Id:156573

40. Schembl81362

41. Mls006010179

42. Chembl544665

43. Fingolimod Hydrochloride- Bio-x

44. Dtxsid00167364

45. Ex-a960

46. Tdi-132

47. Bcpp000225

48. Bcp01808

49. 2-amino-2-[2-(4-octyl-phenyl)-ethyl]-propane-1,3-diol Hcl

50. Fingolimod Hydrochloride (jan/usan)

51. Fingolimod Hydrochloride [mi]

52. S5002

53. Fingolimod Hydrochloride [jan]

54. Akos005145784

55. Ac-1929

56. Am84549

57. Bcp9000705

58. Ccg-265016

59. Cs-0114

60. Ks-1172

61. Fingolimod Hydrochloride [usp-rs]

62. Fingolimod Hydrochloride [who-dd]

63. Bf164458

64. Hy-12005

65. Smr004701287

66. Sy057854

67. Db-014816

68. A8548

69. F1018

70. Ft-0643569

71. Sw219384-1

72. Ec-000.2314

73. Fingolimod Hydrochloride [orange Book]

74. A25158

75. D04187

76. Fingolimod Hydrochloride [ep Monograph]

77. Fingolimod Hydrochloride [usp Monograph]

78. 359f560

79. Sr-01000942237

80. Q-101363

81. Sr-01000942237-2

82. Q27132395

83. 2-(4-octylphenethyl)-2-aminopropane-1,3-diol Hydrochloride

84. 2-amino-2-[2-(4-octylphenyl) Ethyl]-1,3-propanediol Hydrochloride

85. 2-amino-2-[2-(4-octylphenyl)-ethyl]-1,3-propanediol Hydrochloride

86. [1-hydroxy-2-(hydroxymethyl)-4-(4-octylphenyl)butan-2-yl]azanium;chloride

87. 2-amino-2-[2-(4-n-octylphenyl)ethyl]propane-1,3-diol Hydrochloride

88. 2-amino-2-[2-(4-octyl-phenyl)-ethyl]-propane -1,3-diol Hydrochloride

89. 2-amino-2-[2-(4-octyl-phenyl)-ethyl]-propane-1,3-diol Hydrochloride

90. 1,3-propanediol, 2-amino-2-[2-(4-octylphenyl)ethyl]-, Hydrochloride (1:1)

2.4 Create Date

2005-08-08

3 Chemical and Physical Properties

Molecular Formula	C₁₉H₃₄ClNO₂
Molecular Weight	343.9 g/mol
Hydrogen Bond Donor Count	4
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	12
Exact Mass	343.2278070 g/mol
Monoisotopic Mass	343.2278070 g/mol
Topological Polar Surface Area	66.5 Å²
Heavy Atom Count	23
Formal Charge	0
Complexity	258
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
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 2
Drug Name	Gilenya
PubMed Health	Fingolimod (By mouth)
Drug Classes	Immune Modulator
Drug Label	Fingolimod is a sphingosine 1-phosphate receptor modulator.Chemically, fingolimod is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below: Fingolimod hydrochloride is a white to practically white powder that i...
Active Ingredient	Fingolimod
Dosage Form	Capsule
Route	Oral
Strength	0.5mg
Market Status	Prescription
Company	Novartis

2 of 2
Drug Name	Gilenya
PubMed Health	Fingolimod (By mouth)
Drug Classes	Immune Modulator
Drug Label	Fingolimod is a sphingosine 1-phosphate receptor modulator.Chemically, fingolimod is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below: Fingolimod hydrochloride is a white to practically white powder that i...
Active Ingredient	Fingolimod
Dosage Form	Capsule
Route	Oral
Strength	0.5mg
Market Status	Prescription
Company	Novartis

4.2 Drug Indication

Gilenya is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older:

- Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 and 5. 1).

- Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Sphingosine 1 Phosphate Receptor Modulators

Agents that affect the function of G-protein coupled SPHINGOSINE 1-PHOSPHATE RECEPTORS. Their binding to the receptors blocks lymphocyte migration and are often used as IMMUNOSUPPRESSANTS. (See all compounds classified as Sphingosine 1 Phosphate Receptor Modulators.)

Immunosuppressive Agents

Agents that suppress immune function by one of several mechanisms of action. Classical cytotoxic immunosuppressants act by inhibiting DNA synthesis. Others may act through activation of T-CELLS or by inhibiting the activation of HELPER CELLS. While immunosuppression has been brought about in the past primarily to prevent rejection of transplanted organs, new applications involving mediation of the effects of INTERLEUKINS and other CYTOKINES are emerging. (See all compounds classified as Immunosuppressive Agents.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Sphingosine 1-phosphate Receptor Modulator [EPC]; Sphingosine 1-Phosphate Receptor Modulators [MoA]

5.3 ATC Code

L04AA27

API SUPPLIERS

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API Reference Price

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