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ACTIVE PHARMA INGREDIENTS

29 API Suppliers, 10 USDMF, 6 JDMF, 5 EU WC, 1 KDMF, 11 NDC API, 18 Listed Suppliers, $ API Reference Price

29 API Suppliers
10 USDMF
6 JDMF
5 EU WC
1 KDMF
11 NDC API
18 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

27 Drugs in Development

27 Drugs in Development

FINISHED DOSAGE FORMULATIONS

19 FDF Dossiers, 10 FDA Orange Book, 2 Canada, 7 Listed Dossiers

19 FDF Dossiers
10 FDA Orange Book
2 Canada
7 Listed Dossiers

RELATED EXCIPIENT COMPANIES

2 Actylis

relatedExcipients
2 Actylis

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 72 NEWS #PharmaBuzz

media
4 DATA COMPILATION #PharmaFlow
72 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 10 Annual Reports

globalSalesInformation
1 US Medicaid Prescriptions
10 Annual Reports

MARKET PLACE

12 APIs, 1 FDF Dossiers

marketPlace
12 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

5 US Patents, 4 US Exclusivities

patents
5 US Patents
4 US Exclusivities

REF. STANDARDS & IMPURITIES

7 Others

otherSolutions
7 Others

Interquim Edaravone

Synopsis

ACTIVE PHARMA INGREDIENTS

29

API Suppliers

10

USDMF

0

CEP/COS

CEP/COS Certifications

6

JDMF

5

EU WC

1

KDMF

11

NDC API

0

VMF

18

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 11,776

MARKET PLACE

12

API

1

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

19

FDF Dossiers

10

FDA Orange Book

FDA (Orange Book)

0

Europe

2

Canada

0

Australia

0

South Africa

7

Listed Dossiers

27DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

7

Others

PATENTS & EXCLUSIVITIES

5

US Patents

4

US Exclusivities

0

Health Canada Patents

DIGITAL CONTENT

4

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

72

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

45,010,772

Annual Reports (USD Million)

1,811

Finished Drug Prices

NA

2 RELATED EXCIPIENT COMPANIES

2EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 89-25-8, 3-methyl-1-phenyl-2-pyrazolin-5-one, Radicut, Norphenazone, Mci-186, Developer z

Molecular Formula

C₁₀H₁₀N₂O

Molecular Weight

174.20 g/mol

InChI Key

QELUYTUMUWHWMC-UHFFFAOYSA-N

Edaravone

An antipyrine derivative that functions as a free radical scavenger and neuroprotective agent. It is used in the treatment of AMYOTROPHIC LATERAL SCLEROSIS and STROKE.

1 2D Structure

Edaravone

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

5-methyl-2-phenyl-4H-pyrazol-3-one

2.1.2 InChI

InChI=1S/C10H10N2O/c1-8-7-10(13)12(11-8)9-5-3-2-4-6-9/h2-6H,7H2,1H3

2.1.3 InChI Key

QELUYTUMUWHWMC-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CC1=NN(C(=O)C1)C2=CC=CC=C2

2.2 Synonyms

2.2.1 MeSH Synonyms

1. 1 Phenyl 3 Methyl 5 Pyrazolone

2. 1-phenyl-3-methyl-5-pyrazolone

3. 3 Methyl 1 Phenyl 2 Pyrazolin 5 One

4. 3-methyl-1-phenyl-2-pyrazolin-5-one

5. Edarabone

6. Mci 186

7. Mci-186

8. Mci186

9. Norantipyrine

10. Norphenazone

11. Phenylmethylpyrazolone

12. Radicava

2.2.2 Depositor-Supplied Synonyms

1. 89-25-8

2. 3-methyl-1-phenyl-2-pyrazolin-5-one

3. Radicut

4. Norphenazone

5. Mci-186

6. Developer Z

7. Methylphenylpyrazolone

8. Norantipyrine

9. C.i. Developer 1

10. Phenyl Methyl Pyrazolone

11. Phenylmethylpyrazolone

12. Radicava

13. 3-methyl-1-phenyl-1h-pyrazol-5(4h)-one

14. 5-methyl-2-phenyl-2,4-dihydro-3h-pyrazol-3-one

15. 1-phenyl-3-methyl-5-oxo-2-pyrazoline

16. 5-methyl-2-phenyl-4h-pyrazol-3-one

17. 1-phenyl-3-methylpyrazolone

18. 3h-pyrazol-3-one, 2,4-dihydro-5-methyl-2-phenyl-

19. 1-phenyl-3-methylpyrazolone-5

20. 3-methyl-1-phenylpyrazol-5-one

21. 3-methyl-1-phenyl-2-pyrazoline-5-one

22. Nci-c03952

23. 2-pyrazolin-5-one, 3-methyl-1-phenyl-

24. 5-pyrazolone, 3-methyl-1-phenyl-

25. 2,4-dihydro-5-methyl-2-phenyl-3h-pyrazol-3-one

26. Edaravone (mci-186)

27. 1-fenyl-3-methyl-2-pyrazolin-5-on

28. 3-methyl-1-phenyl-4,5-dihydro-1h-pyrazol-5-one

29. Chebi:31530

30. Nsc-2629

31. Nsc-26139

32. Antipyrine Related Compound A

33. Mls000069602

34. 3-methyl-1-phenyl-2-pyrazolin-5-one (mci-186)

35. Ci Developer 1

36. Ncgc00164015-01

37. Smr000059020

38. Dsstox_cid_1130

39. Dsstox_rid_75961

40. Dsstox_gsid_21130

41. Monopyrazolone

42. Wln: T5nmv Dhj Br& E1

43. Cas-89-25-8

44. Ccris 512

45. Radicut (tn)

46. Hsdb 4102

47. 3h-pyrazol-3-one,4-dihydro-5-methyl-2-phenyl-

48. Sr-01000000135

49. 1-fenyl-3-methyl-2-pyrazolin-5-on [czech]

50. Einecs 201-891-0

51. Mfcd00003138

52. Unii-s798v6yjrp

53. Brn 0609575

54. Ai3-03557

55. Mci186

56. (edaravone)

57. Radicava (tn)

58. (mci-186)

59. Cds1_000986

60. Spectrum_000267

61. Tocris-0786

62. Mci-186; Edaravone

63. Edaravone [usan:inn]

64. Maybridge1_005738

65. Opera_id_1057

66. Spectrum2_001574

67. Spectrum3_000971

68. Spectrum4_001091

69. Spectrum5_001217

70. M0687

71. Ec 201-891-0

72. Schembl4704

73. Bspbio_001235

74. Bspbio_002601

75. Kbiogr_000575

76. Kbiogr_001502

77. Kbioss_000575

78. Kbioss_000747

79. Ae-641/00371017

80. Mls001146878

81. Mls002415675

82. Mls006011753

83. Divk1c_001018

84. Divk1c_002026

85. Spectrum1503635

86. Spbio_001508

87. Chembl290916

88. Edaravone (usan/jp17/inn)

89. Dtxsid9021130

90. Bcbcmap01_000127

91. Gtpl11994

92. Hms503k17

93. Hms557m18

94. Kbio1_001018

95. Kbio2_000575

96. Kbio2_000747

97. Kbio2_003143

98. Kbio2_003315

99. Kbio2_005711

100. Kbio2_005883

101. Kbio3_001029

102. Kbio3_001030

103. Kbio3_001821

104. Nsc2629

105. Ninds_001018

106. Bcpp000246

107. Bio1_000438

108. Bio1_000927

109. Bio1_001416

110. Bio2_000448

111. Bio2_000928

112. Hms1362m17

113. Hms1792m17

114. Hms1990m17

115. Hms2234m19

116. Hms3266f04

117. Hms3403m17

118. Hms3411l05

119. Hms3654l15

120. Hms3675l05

121. Hms3884a11

122. Pharmakon1600-01503635

123. Act07289

124. Bcp26336

125. Hy-b0099

126. Nsc26139

127. Tox21_112077

128. Tox21_201747

129. Tox21_302819

130. Bdbm50200541

131. Ccg-39352

132. Nsc758622

133. S1326

134. Stk201315

135. Zinc18203737

136. 3-methyl-1-phenyl-2-pyrazolin-5one

137. Akos000313817

138. Tox21_112077_1

139. Ac-4745

140. Bcp9000635

141. Cs-1832

142. Db12243

143. Nsc-758622

144. Sb19128

145. Idi1_001018

146. Idi1_002203

147. 1-pehnyl-3-methyl-5-pyrazalone

148. Ncgc00018218-01

149. Ncgc00018218-02

150. Ncgc00018218-03

151. Ncgc00018218-04

152. Ncgc00018218-05

153. Ncgc00018218-06

154. Ncgc00018218-07

155. Ncgc00018218-08

156. Ncgc00018218-10

157. Ncgc00018218-17

158. Ncgc00022665-02

159. Ncgc00022665-04

160. Ncgc00022665-05

161. Ncgc00022665-06

162. Ncgc00256515-01

163. Ncgc00259296-01

164. Sbi-0051836.p002

165. Db-002517

166. Am20060748

167. Ft-0608243

168. Sw148216-2

169. 5-methyl-2-phenyl-2,4-dihydro-3-pyrazolone

170. 3-methyl-1-phenyl-2-pyrazoline-5-one, 99%

171. 4e-901

172. 5-methyl-2-phenyl-2,4-dihydro-pyrazol-3-one

173. D01552

174. D86209

175. 3-?methyl-?1-?phenyl-?2-?pyrazolin-?5-?one

176. Ab00375776_14

177. Ab00375776_15

178. 2 4-dihydro-5-methyl-2-phenyl-3h-pyrazol-3-one

179. 2,4-dihydro-2-phenyl-5-methyl-3h-pyrazol-3-one

180. A843105

181. Q335099

182. Q-200386

183. Sr-01000000135-2

184. Sr-01000000135-3

185. Sr-01000000135-5

186. 5-methyl-2-phenyl-2,4-dihydro-3h-pyrazol-3-one #

187. Brd-k35458079-001-04-2

188. Brd-k35458079-001-12-5

189. Brd-k35458079-001-23-2

190. Z50145861

191. F0391-0021

192. 3-methyl-1-phenyl-2-pyrazoline-5-one, Saj Special Grade

193. 3-methyl-1-phenyl-2-pyrazoline-5-one, Purum, >=98.0% (nt)

194. 5-methyl-2-phenyl-2,4-dihydro-3h-pyrazol-3-one (edaravone)

195. Phenazone Impurity A, European Pharmacopoeia (ep) Reference Standard

196. 5-methyl-2-phenyl-1,2-dihydropyrazol-3-one;3-methyl-1-phenyl-2-pyrazolin-5-one

197. Antipyrine Related Compound A, United States Pharmacopeia (usp) Reference Standard

2.3 Create Date

2005-03-25

3 Chemical and Physical Properties

Molecular Formula	C₁₀H₁₀N₂O
Molecular Weight	174.20 g/mol
XLogP3	1.3
Hydrogen Bond Donor Count	0
Hydrogen Bond Acceptor Count	2
Rotatable Bond Count	1
Exact Mass	174.079312947 g/mol
Monoisotopic Mass	174.079312947 g/mol
Topological Polar Surface Area	32.7 Å²
Heavy Atom Count	13
Formal Charge	0
Complexity	241
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	1

4 Drug and Medication Information

4.1 Drug Indication

Indicated for improving neurological symptoms and damage from acute ischemic stroke and delaying disease progression of ALS.

FDA Label

Treatment of amyotrophic lateral sclerosis

Treatment of amyotrophic lateral sclerosis

5 Pharmacology and Biochemistry

5.1 Pharmacology

Edaravone scavenges free hydroxyl radicals and peroxynitrite radicals which are highly associated with neuronal damage/death from many cerebral vascular disorders such as ischemic strokes and degenerative neurological disorders such as ALS. It exerts a neuroprotective and antioxidant effect and delays disease progression by limiting the extent of lipid peroxidation via free radical generation and cell membrane damage from oxidative stress. It reversed the reduction in regional blood flow and cerebral edema in a case of ischemic stroke.

5.2 MeSH Pharmacological Classification

Free Radical Scavengers

Substances that eliminate free radicals. Among other effects, they protect PANCREATIC ISLETS against damage by CYTOKINES and prevent myocardial and pulmonary REPERFUSION INJURY. (See all compounds classified as Free Radical Scavengers.)

Neuroprotective Agents

Drugs intended to prevent damage to the brain or spinal cord from ischemia, stroke, convulsions, or trauma. Some must be administered before the event, but others may be effective for some time after. They act by a variety of mechanisms, but often directly or indirectly minimize the damage produced by endogenous excitatory amino acids. (See all compounds classified as Neuroprotective Agents.)

5.3 ATC Code

N - Nervous system

N07 - Other nervous system drugs

N07X - Other nervous system drugs

N07XX - Other nervous system drugs

N07XX14 - Edaravone

5.4 Absorption, Distribution and Excretion

Absorption

The peak plasma concentration of the parent drug is reached at the end of infusion, without accumulation of the drug with multiple dosing regimen. The mean Cmax value in healthy male adults is 888ng/mL for intravenous infusion. The values of AUC and Cmax are increased in a dose-proportional relationship. The oral bioavailability in mouse studies is 38% of the I.V. delivery.

Route of Elimination

About 0.7-0.9% of the dose is excreted as unchanged drug and 71.0-79.9% of the dose is excreted as metabolites (mostly as glucuronide conjugates) through mainly renal elimination.

Volume of Distribution

The mean Vd value following an intravenous infusion of a single 30mg dose is 18.5L/kg.

Clearance

The mean total plasma drug clearance following an intravenous infusion of a single 30mg dose is 0.1L/min.

5.5 Metabolism/Metabolites

Multiple renal and hepatic uridine diphosphate glucuronosyltransferase (UGT) isoforms catalyze glucuronidation reaction of edaravone to form glucuronide conjugates. Edaravone is also metabolized into sulfate conjugates via sulfotransferase activity, which is the main metabolite form predominantly found circulating in plasma. It is predicted that the sulfate conjugate is hydrolyzed back to edaravone, which is then converted to the glucuronide conjugate in the human kidney before excretion into the urine. These metabolites have no pharmacological activity.

5.6 Biological Half-Life

The mean terminal elimination half-life of edaravone is 4.5 to 6 hours and the half-lives of its metabolites are 2 to 2.8 hours.

5.7 Mechanism of Action

Nootropic and neuroprotective effects are mediated through inhibiting lipid peroxidation and scavenging free radicals. Edaravone acts to increase prostacyclin production, decrease lipoxygenase metabolism of arachidonic acid by trapping hydroxyl radicals, and inhibit alloxan-induced lipid peroxidation and quench active oxygen species. It targets various kinds of cells, including neurons, endothelial cells and myocardial cells. There is also evidence of reduction of neuronal nitric oxide synthase (nNOS) levels and potentiation of SOD1 levels after transient ischemia in rabbits thus preventing spinal cord injury.

API SUPPLIERS

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USDMF

01

Biophore India Pharmaceuticals Pvt L...

India

CPhI India 2024

Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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India

Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2024-02-27

Pay. Date : 2024-01-22

DMF Number : 34751

Submission : 2020-06-16

Status : Active

Type : II

Product Web Link

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Dr Reddys Laboratories Ltd

India

CPhI India 2024

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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India

Digital Content

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DMF Review : Complete

Rev. Date : 2020-11-01

Pay. Date : 2020-09-21

DMF Number : 34449

Submission : 2019-12-31

Status : Active

Type : II

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Medichem Manufacturing Malta Ltd

Spain

CPhI India 2024

Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

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Spain

Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2020-12-04

Pay. Date : 2020-10-15

DMF Number : 35211

Submission : 2020-10-26

Status : Active

Type : II

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Neuland Laboratories Ltd

India

TIDES Europe 2024

Neuland Laboratories- A dedicated 100% API provider.

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India

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DMF Review : Complete

Rev. Date : 2020-12-16

Pay. Date : 2020-10-23

DMF Number : 35204

Submission : 2020-09-29

Status : Active

Type : II

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Cipla Ltd

India

Compamed

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Gland Pharma Ltd

India

Compamed

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Msn Laboratories Private Ltd

India

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08

Quimica Sintetica Sa

Spain

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Solara Active Pharma Sciences Ltd

India

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Yung Zip Chemical Ind Co Ltd

Taiwan

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API Reference Price

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Number of Transactions

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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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