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ACTIVE PHARMA INGREDIENTS

49 API Suppliers, 20 USDMF, 6 EU WC, 1 KDMF, 9 NDC API, 37 Listed Suppliers, $ API Reference Price

49 API Suppliers
20 USDMF
6 EU WC
1 KDMF
9 NDC API
37 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

25 Drugs in Development

25 Drugs in Development

INTERMEDIATES

17 Intermediates Suppliers

17 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

118 FDF Dossiers, 91 FDA Orange Book, 6 Europe, 6 Canada, 4 Australia, 5 South Africa, 6 Listed Dossiers

118 FDF Dossiers
91 FDA Orange Book
6 Europe
6 Canada
4 Australia
5 South Africa
6 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 0.25MG, TABLET;ORAL - 0.5MG, TABLET;ORAL - 1MG, TABLET;ORAL - 2MG, TABLET;ORAL - 3MG, TABLET;ORAL - 4MG

drugProductComposition
TABLET;ORAL - 0.25MG
TABLET;ORAL - 0.5MG
TABLET;ORAL - 1MG
TABLET;ORAL - 2MG
TABLET;ORAL - 3MG
TABLET;ORAL - 4MG

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 3 DKSH, 3 Faran Shimi Pharmaceutical, 10 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 1 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 10 Corel Pharma Chem, 4 DFE Pharma, 5 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 29 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 3 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

EXCIPIENTS BY APPLICATIONS

55 Fillers, Diluents & Binders, 43 Coating Systems & Additives, 24 Direct Compression, 21 Controlled & Modified Release, 13 Co-Processed Excipients, 12 Thickeners and Stabilizers, 12 Lubricants & Glidants, 11 Disintegrants & Superdisintegrants, 11 Granulation, 7 Film Formers & Plasticizers, 7 Taste Masking, 6 Chewable & Orodispersible Aids, 5 Coloring Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 3 API Stability Enhancers, 2 Emulsifying Agents, 2 Rheology Modifiers, 1 Solubilizers, 1 Parenteral

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 54 NEWS #PharmaBuzz

media
3 DATA COMPILATION #PharmaFlow
54 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 6 Finished Drug Prices, 16 Annual Reports

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

MARKET PLACE

9 APIs, 1 FDF Dossiers

marketPlace
9 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

88 US Patents, 30 US Exclusivities

patents
88 US Patents
30 US Exclusivities

REF. STANDARDS & IMPURITIES

8 Others

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8 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 10,822

MARKET PLACE

API

FDF

17INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

118

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

25DRUGS 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)

490,498,963

Annual Reports (USD Million)

9,779

Finished Drug Prices

151 RELATED EXCIPIENT COMPANIES

245EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 913611-97-9, Opc-34712, Rexulti, 7-(4-(4-(benzo[b]thiophen-4-yl)piperazin-1-yl)butoxy)quinolin-2(1h)-one, Opc 34712, 2j3ybm1k8c

Molecular Formula

C₂₅H₂₇N₃O₂S

Molecular Weight

433.6 g/mol

InChI Key

ZKIAIYBUSXZPLP-UHFFFAOYSA-N

FDA UNII

2J3YBM1K8C

Brexpiprazole is a novel D2 dopamine and serotonin 1A partial agonist, called serotonin-dopamine activity modulator (SDAM), and a potent antagonist of serotonin 2A receptors, noradrenergic alpha 1B and 2C receptors. Brexpiprazole is approved for the treatment of schizophrenia, and as an adjunctive treatment for major depressive disorder (MDD). Although it failed Phase II clinical trials for ADHD, it has been designed to provide improved efficacy and tolerability (e.g., less akathisia, restlessness and/or insomnia) over established adjunctive treatments for major depressive disorder (MDD).

Brexpiprazole is an Atypical Antipsychotic.

1 2D Structure

Brexpiprazole

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

7-[4-[4-(1-benzothiophen-4-yl)piperazin-1-yl]butoxy]-1H-quinolin-2-one

2.1.2 InChI

InChI=1S/C25H27N3O2S/c29-25-9-7-19-6-8-20(18-22(19)26-25)30-16-2-1-11-27-12-14-28(15-13-27)23-4-3-5-24-21(23)10-17-31-24/h3-10,17-18H,1-2,11-16H2,(H,26,29)

2.1.3 InChI Key

ZKIAIYBUSXZPLP-UHFFFAOYSA-N

2.1.4 Canonical SMILES

C1CN(CCN1CCCCOC2=CC3=C(C=C2)C=CC(=O)N3)C4=C5C=CSC5=CC=C4

2.2 Other Identifiers

2.2.1 UNII

2J3YBM1K8C

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 7-(4-(4-(1-benzothiophen-4-yl)piperazin-1-yl)butoxy)quinolin-2(1h)-one

2. Rexulti

2.3.2 Depositor-Supplied Synonyms

1. 913611-97-9

2. Opc-34712

3. Rexulti

4. 7-(4-(4-(benzo[b]thiophen-4-yl)piperazin-1-yl)butoxy)quinolin-2(1h)-one

5. Opc 34712

6. 2j3ybm1k8c

7. 7-(4-(4-(1-benzothiophen-4-yl)piperazin-1-yl)butoxy)quinolin-2(1h)-one

8. 7-[4-[4-(1-benzothiophen-4-yl)piperazin-1-yl]butoxy]-1h-quinolin-2-one

9. Brexpiprazole [usan]

10. Unii-2j3ybm1k8c

11. Brexpiprazole [usan:inn]

12. Rxulti

13. Rexulti (tn)

14. Brexpiprazole.2h2o

15. Brexpiprazole-[d8]

16. Brexpiprazole [mi]

17. Brexpiprazole [inn]

18. Brexpiprazole [jan]

19. Brexpiprazole(opc34712)

20. Brexpiprazole; Opc-34712

21. Brexpiprazole [who-dd]

22. Gtpl7672

23. Schembl1037592

24. Brexpiprazole (jan/usan/inn)

25. Chembl2105760

26. Schembl14772509

27. Amy6914

28. Dtxsid40238527

29. Chebi:134716

30. Hms3885p12

31. Brexpiprazole [orange Book]

32. Bcp10218

33. Bcp24077

34. Ex-a2639

35. Opc34712

36. Mfcd27987920

37. S4639

38. Zinc84758479

39. Akos025291100

40. Akos037515802

41. Ccg-269055

42. Db09128

43. Sb16735

44. Ncgc00378574-01

45. Ncgc00378574-02

46. Ac-30404

47. As-56467

48. Da-35913

49. Hy-15780

50. Ft-0712292

51. A13527

52. D10309

53. Q2924764

54. 2(1h)-quinolinone, 7-(4-(4-benzo(b)thien-4-yl-1-piperazinyl)butoxy)-

55. 7-[4-(4-benzo[b]thien-4-yl-1-piperazinyl)butoxy]- 2(1h)-quinolinone

56. 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1h-quinolin-2-one

57. 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1h-quinolin-2-one

58. 7-[4-(4-benzo[b]thiophen-4-ylpiperazin-1-yl)butoxy]-1h-quinolin-2-one

2.4 Create Date

2007-01-03

3 Chemical and Physical Properties

Molecular Formula	C₂₅H₂₇N₃O₂S
Molecular Weight	433.6 g/mol
XLogP3	4.7
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	7
Exact Mass	433.18239829 g/mol
Monoisotopic Mass	433.18239829 g/mol
Topological Polar Surface Area	73 Å²
Heavy Atom Count	31
Formal Charge	0
Complexity	636
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

As an adjunctive treatment of major depressive disorder (MDD) and for treatment of schizophrenia.

FDA Label

Treatment of schizophrenia.

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Dopamine Agonists

Drugs that bind to and activate dopamine receptors. (See all compounds classified as Dopamine Agonists.)

Serotonin Agents

Drugs used for their effects on serotonergic systems. Among these are drugs that affect serotonin receptors, the life cycle of serotonin, and the survival of serotonergic neurons. (See all compounds classified as Serotonin Agents.)

5.2 FDA Pharmacological Classification

5.2.1 Active Moiety

BREXPIPRAZOLE

5.2.2 FDA UNII

2J3YBM1K8C

5.2.3 Pharmacological Classes

Atypical Antipsychotic [EPC]

5.3 ATC Code

N05AX16

N - Nervous system

N05 - Psycholeptics

N05A - Antipsychotics

N05AX - Other antipsychotics

N05AX16 - Brexpiprazole

5.4 Absorption, Distribution and Excretion

Absorption

Brexpiprazole reaches peak plasma concentration within 4 hours of administration, and steady state occurs within 10-12 days of dosing. Oral bioavailability is 95%, and can be administered with or without food.

Route of Elimination

Approximately 25% urinary and 46% fecal excretion. <1% and ~14% of the unchanged drug was recovered in the urine and feces, respectively.

Volume of Distribution

Intravenous volume of distribution is 1.56L/kg.

Clearance

19.8mL/h/kg

5.5 Metabolism/Metabolites

Metabolized mainly by CYP3A4 and CYP2D6 enzymes into its major metabolite, DM-3411. DM-3411 is not considered to contribute any therapeutic effect.

5.6 Biological Half-Life

Brexpiprazole and its major metabolite, DM-3411 have half lives of 91 and 96 hours respectively.

5.7 Mechanism of Action

Although the mechanism of action of brexpiprazole in the treatment of MDD and schizophrenia is unclear, the efficacy of brexpiprazole may be attributed to partial agonist activity at serotonin 1A and dopamine D2 receptors, and antagonist activity at serotonin 2A receptors.

API SUPPLIERS

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USDMF

01

Zaklady Farmaceutyczne Polpharma Sa

Poland

euroPLX 86 Munich

Not Confirmed

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

Contact Supplier

Poland

Virtual Booth

Digital Content

Brexpiprazole

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 32347

Submission : 2017-12-21

Status : Active

Type : II

02

Biophore India Pharmaceuticals Pvt L...

India

CPhI India 2024

Booth #1.A01

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

Contact Supplier

India

Virtual Booth

Digital Content

Brexpiprazole

GDUFA

DMF Review : Complete

Rev. Date : 2019-04-16

Pay. Date : 2019-03-22

DMF Number : 33704

Submission : 2019-03-20

Status : Active

Type : II

03

Alembic Pharmaceuticals Ltd

India

euroPLX 86 Munich

Not Confirmed

04

Honour Lab Ltd

India

India

euroPLX 86 Munich

Not Confirmed

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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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DOSAGE - TABLET;ORAL - 0.25MG