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Eltrombopag

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ACTIVE PHARMA INGREDIENTS

40 API Suppliers, 17 USDMF, 5 EU WC, 12 NDC API, 30 Listed Suppliers, $ API Reference Price

40 API Suppliers
17 USDMF
5 EU WC
12 NDC API
30 Listed Suppliers
$ API Reference Price

INTERMEDIATES

17 Intermediates Suppliers

17 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

82 FDF Dossiers, 25 FDA Orange Book, 10 Europe, 4 Canada, 16 Australia, 2 South Africa, 25 Listed Dossiers

82 FDF Dossiers
25 FDA Orange Book
10 Europe
4 Canada
16 Australia
2 South Africa
25 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 12.5MG ACID, TABLET;ORAL - EQ 25MG ACID, TABLET;ORAL - EQ 50MG ACID, TABLET;ORAL - EQ 75MG ACID

drugProductComposition
TABLET;ORAL - EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 12.5MG ACID
TABLET;ORAL - EQ 25MG ACID
TABLET;ORAL - EQ 50MG ACID
TABLET;ORAL - EQ 75MG ACID

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 13 SPI Pharma, 5 DKSH, 1 Jai Radhe Sales, 2 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 9 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 2 Actylis, 1 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 12 BASF, 1 Bioplus Life Sciences, 1 Clariant, 10 Corel Pharma Chem, 3 DFE Pharma, 10 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 19 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 Nanjing Bold Chemical, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 14 Roquette, 12 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

51 Coating Systems & Additives, 49 Fillers, Diluents & Binders, 29 Direct Compression, 27 Controlled & Modified Release, 20 Thickeners and Stabilizers, 18 Solubilizers, 18 Disintegrants & Superdisintegrants, 16 Granulation, 14 Taste Masking, 13 Parenteral, 13 Lubricants & Glidants, 13 Co-Processed Excipients, 12 Chewable & Orodispersible Aids, 11 Film Formers & Plasticizers, 8 Topical, 7 API Stability Enhancers, 6 Rheology Modifiers, 5 Coloring Agents, 5 Emulsifying Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 26 NEWS #PharmaBuzz

media
2 DATA COMPILATION #PharmaFlow
26 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 6 Finished Drug Prices, 14 Annual Reports

globalSalesInformation
1 US Medicaid Prescriptions
6 Finished Drug Prices
14 Annual Reports

MARKET PLACE

13 APIs, 7 FDF Dossiers

marketPlace
13 APIs
7 FDF Dossiers

PATENTS & EXCLUSIVITIES

101 US Patents, 7 US Exclusivities, 9 Health Canada Patents

patents
101 US Patents
7 US Exclusivities
9 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)

$ 10,323

MARKET PLACE

API

FDF

17INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

101

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)

454,825,188

Annual Reports (USD Million)

21,119

Finished Drug Prices

194 RELATED EXCIPIENT COMPANIES

347EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 496775-62-3, Revolade, Promacta, Eltrombopag (olamine), Unii-4u07f515lg, Sb-497115-gr

Molecular Formula

C₂₉H₃₆N₆O₆

Molecular Weight

564.6 g/mol

InChI Key

DJMJHIKGMVJYCW-UHFFFAOYSA-N

FDA UNII

4U07F515LG

Eltrombopag Olamine is the orally active ethanolamine salt of eltrombopag, a small-molecule, nonpeptide thrombopoietin receptor agonist with megakaryopoiesis-stimulating activity. Eltrombopag binds to and stimulates the transmembrane domain of the platelet thrombopoietin receptor (TPO-R or CD110), a member of the hematopoietin receptor superfamily. Activation of TPO-R leads to the proliferation and differentiation of cells in the megakaryocytic lineage and an increase in platelet production.

1 2D Structure

Eltrombopag

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2-aminoethanol;3-[3-[[2-(3,4-dimethylphenyl)-5-methyl-3-oxo-1H-pyrazol-4-yl]diazenyl]-2-hydroxyphenyl]benzoic acid

2.1.2 InChI

InChI=1S/C25H22N4O4.2C2H7NO/c1-14-10-11-19(12-15(14)2)29-24(31)22(16(3)28-29)27-26-21-9-5-8-20(23(21)30)17-6-4-7-18(13-17)25(32)33;2*3-1-2-4/h4-13,28,30H,1-3H3,(H,32,33);2*4H,1-3H2

2.1.3 InChI Key

DJMJHIKGMVJYCW-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CC1=C(C=C(C=C1)N2C(=O)C(=C(N2)C)N=NC3=CC=CC(=C3O)C4=CC(=CC=C4)C(=O)O)C.C(CO)N.C(CO)N

2.2 Other Identifiers

2.2.1 UNII

4U07F515LG

2.3 Synonyms

2.3.1 MeSH Synonyms

1. (1,1'-biphenyl)-3-carboxylic Acid, 3'-((2z)-(1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene)hydrazino)-2'-hydroxy-

2. Ddl-701

3. Eltrombopag

4. Promacta

5. Revolade

6. Sb-497 115

7. Sb-497-115

8. Sb497115

2.3.2 Depositor-Supplied Synonyms

1. 496775-62-3

2. Revolade

3. Promacta

4. Eltrombopag (olamine)

5. Unii-4u07f515lg

6. Sb-497115-gr

7. Eltrombopag Diethanolamine Salt

8. 496775-62-3 (olamine)

9. Eltrombopag (as Olamine)

10. 4u07f515lg

11. Sb-497115gr

12. Eltrombopag Compd With 2-aminoethanol (1:2)

13. Eltrombopag Diethanolamine Salt;sb-497115gr

14. (z)-3'-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4h-pyrazol-4-ylidene)hydrazinyl)-2'-hydroxy-[1,1'-biphenyl]-3-carboxyiic Acid;2-aminoethan-1-ol (1:2)

15. 3'-((2z)-2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4h-pyrazol-4-ylidene)diazanyl)-2'-hydroxybiphenyl-3-carboxylic Acid Compound With 2-aminoethanol (1:2)

16. Promacta Olamine

17. Eltrombopagolamine

18. Eltrombopag Olamine [usan:jan]

19. Promacta (tn)

20. Sb 497115gr

21. Schembl210183

22. Amy267

23. Chembl3989691

24. Schembl16207741

25. Schembl23458316

26. Eltrombopag Olamine (jan/usan)

27. Eltrombopag Olamine [jan]

28. Eltrombopag Olamine [usan]

29. Bcp07055

30. Eltrombopag Olamine [mart.]

31. Eltrombopag Olamine [who-dd]

32. Hy-15306a

33. Mfcd22380664

34. S2229

35. Akos025396658

36. Akos037515856

37. Ccg-270074

38. Cs-1566

39. Sb19102

40. Eltrombopag Olamine [orange Book]

41. 2-aminoethan-1-ol Hemi((e)-3'-(2-(2-(3,4-dimethylphenyl)-5-methyl-3-oxo-2,3-dihydro-1h-pyrazol-4-yl)hydrazono)-2'-oxo-2',3'-dihydro-[1,1'-biphenyl]-3-carboxylate)

42. Ac-26286

43. Bs-17370

44. Ft-0773802

45. D03978

46. A904098

47. Q27260489

48. Eltrombopag Compd With 2-aminoethanol (1:2) [mi]

49. (1,1'-biphenyl)-3-carboxylic Acid, 3'-((2z)-(1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene)hydrazino)-2'-hydroxy, Compound With 2-aminoethanol (1:2)

50. (1,1'-biphenyl)-3-carboxylic Acid, 3'-((2z)-(1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene)hydrazino)-2'-hydroxy-, Compound With 2-aminoethanol (1:2)

51. (1,1'-biphenyl)-3-carboxylic Acid, 3'-(2-(1-(3,4-dimethylphenyl)-4,5-dihydro-3-methyl-5-oxo-1h-pyrazol-4-yl)diazenyl)-2'-hydroxy-, Compd. With 2-aminoethanol (1:2)

52. 2-aminoethan-1-ol Hemi((z)-3'-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4h-pyrazol-4-ylidene)hydrazinyl)-2'-hydroxy-[1,1'-biphenyl]-3-carboxylate)

53. 2-aminoethanol (e)-3'-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1h-pyrazol-4(5h)-ylidene)hydrazinyl)-2'-hydroxy-[1,1'-biphenyl]-3-carboxylate

54. 2-aminoethanol;3-[3-[[2-(3,4-dimethylphenyl)-5-methyl-3-oxo-1h-pyrazol-4-yl]diazenyl]-2-hydroxyphenyl]benzoic Acid

55. 3'-[(2z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic Acid Bis-(monoethanolamine)

56. 3'-[(2z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol4-ylidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic Acid Bis-(monoethanolamine)

57. 3'-{(2z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4h-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic Acid 2-aminoethanol (1:2)

2.4 Create Date

2019-01-15

3 Chemical and Physical Properties

Molecular Formula	C₂₉H₃₆N₆O₆
Molecular Weight	564.6 g/mol
Hydrogen Bond Donor Count	7
Hydrogen Bond Acceptor Count	11
Rotatable Bond Count	7
Exact Mass	564.26963289 g/mol
Monoisotopic Mass	564.26963289 g/mol
Topological Polar Surface Area	207 Å²
Heavy Atom Count	41
Formal Charge	0
Complexity	822
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	3

4 Drug and Medication Information

4.1 Drug Indication

Revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e. g. corticosteroids, immunoglobulins) (see sections 4. 2 and 5. 1).

Revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e. g. corticosteroids, immunoglobulins) (see sections 4. 2 and 5. 1).

Revolade is indicated in adult patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4. 4 and 5. 1).

Revolade is indicated in adult patients with acquired severe aplastic anaemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5. 1).

5 Pharmacology and Biochemistry

5.1 FDA Pharmacological Classification

5.1.1 Pharmacological Classes

Increased Megakaryocyte Maturation [PE]; Increased Platelet Production [PE]; Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]; Thrombopoietin Receptor Agonist [EPC]; Thrombopoietin Receptor Agonists [MoA]; UGT1A1 Inhibitors [MoA]; UGT1A3 Inhibitors [MoA]; UGT1A4 Inhibitors [MoA]; UGT1A6 Inhibitors [MoA]; UGT1A9 Inhibitors [MoA]; UGT2B15 Inhibitors [MoA]; UGT2B7 Inhibitors [MoA]; Breast Cancer Resistance Protein Inhibitors [MoA]

5.2 ATC Code

B02BX05

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API Reference Price

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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;ORAL - EQ 100MG ACID **Federa...DOSAGE - TABLET;ORAL - EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**