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ACTIVE PHARMA INGREDIENTS

17 API Suppliers, 5 USDMF, 3 EU WC, 6 NDC API, 12 Listed Suppliers

17 API Suppliers
5 USDMF
3 EU WC
6 NDC API
12 Listed Suppliers

DEVELOPMENTS

25 Drugs in Development

25 Drugs in Development

INTERMEDIATES

9 Intermediates Suppliers

9 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

11 FDF Dossiers, 3 FDA Orange Book, 3 Europe, 3 Australia, 1 South Africa, 1 Listed Dossiers

11 FDF Dossiers
3 FDA Orange Book
3 Europe
3 Australia
1 South Africa
1 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 1 SPI Pharma, 13 DKSH, 1 Pharm-RX Chemical, 1 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Aeon Procare, 1 Alcedo Pharmachem, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 7 BASF, 5 Corel Pharma Chem, 2 DFE Pharma, 9 Gangwal Chemicals, 3 Ideal Cures Pvt Ltd, 8 Kerry, 8 Microlex e.U, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 1 Pluviaendo, 2 Prachin Chemical, 9 Roquette, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 1 Ulanqab Kema New Material, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

30 Fillers, Diluents & Binders, 22 Coating Systems & Additives, 20 Direct Compression, 17 Thickeners and Stabilizers, 17 Disintegrants & Superdisintegrants, 13 Lubricants & Glidants, 10 Controlled & Modified Release, 10 Granulation, 9 Co-Processed Excipients, 5 Chewable & Orodispersible Aids, 5 Film Formers & Plasticizers, 5 Solubilizers, 4 Emulsifying Agents, 3 API Stability Enhancers, 3 Taste Masking, 3 Coloring Agents, 3 Topical, 3 Rheology Modifiers, 2 Parenteral

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 2 STOCK RECAP #PipelineProspector, 79 NEWS #PharmaBuzz

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3 DATA COMPILATION #PharmaFlow
2 STOCK RECAP #PipelineProspector
79 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 3 Finished Drug Prices, 7 Annual Reports

globalSalesInformation
1 US Medicaid Prescriptions
3 Finished Drug Prices
7 Annual Reports

MARKET PLACE

3 APIs, 3 FDF Dossiers

marketPlace
3 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

42 US Patents, 4 US Exclusivities

patents
42 US Patents
4 US Exclusivities

Egis Ribociclib

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 0

MARKET PLACE

API

FDF

9INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

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)

166,342,358

Annual Reports (USD Million)

5,726

Finished Drug Prices

106 RELATED EXCIPIENT COMPANIES

184EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Lee011 succinate, 1374639-75-4, Lee-011 succinate, Lee011-bba, Ribociclib succinate [usan], Kisqali

Molecular Formula

C₂₇H₃₆N₈O₅

Molecular Weight

552.6 g/mol

InChI Key

NHANOMFABJQAAH-UHFFFAOYSA-N

FDA UNII

BG7HLX2919

1 2D Structure

Ribociclib

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

butanedioic acid;7-cyclopentyl-N,N-dimethyl-2-[(5-piperazin-1-ylpyridin-2-yl)amino]pyrrolo[2,3-d]pyrimidine-6-carboxamide

2.1.2 InChI

InChI=1S/C23H30N8O.C4H6O4/c1-29(2)22(32)19-13-16-14-26-23(28-21(16)31(19)17-5-3-4-6-17)27-20-8-7-18(15-25-20)30-11-9-24-10-12-30;5-3(6)1-2-4(7)8/h7-8,13-15,17,24H,3-6,9-12H2,1-2H3,(H,25,26,27,28);1-2H2,(H,5,6)(H,7,8)

2.1.3 InChI Key

NHANOMFABJQAAH-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CN(C)C(=O)C1=CC2=CN=C(N=C2N1C3CCCC3)NC4=NC=C(C=C4)N5CCNCC5.C(CC(=O)O)C(=O)O

2.2 Other Identifiers

2.2.1 UNII

BG7HLX2919

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Kisqali

2. Lee011

3. Ribociclib

2.3.2 Depositor-Supplied Synonyms

1. Lee011 Succinate

2. 1374639-75-4

3. Lee-011 Succinate

4. Lee011-bba

5. Ribociclib Succinate [usan]

6. Kisqali

7. Lee-011-bba

8. Bg7hlx2919

9. 7-cyclopentyl-n,n-dimethyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-7h-pyrrolo[2,3-d]pyrimidine-6-carboxamide Succinate

10. Butanedioic Acid;7-cyclopentyl-n,n-dimethyl-2-[(5-piperazin-1-ylpyridin-2-yl)amino]pyrrolo[2,3-d]pyrimidine-6-carboxamide

11. Ribociclib Succinate (usan)

12. Butanedioic Acid, Compd. With 7-cyclopentyl-n,n-dimethyl-2-((5-(1-piperazinyl)-2-pyridinyl)amino)-7h-pyrrolo(2,3-d)pyrimidine-6-carboxamide (1:1)

13. Butanedioic Acid, Compd. With 7-cyclopentyl-n,n-dimethyl-2-[[5-(1-piperazinyl)-2-pyridinyl]amino]-7h-pyrrolo[2,3-d]pyrimidine-6-carboxamide (1:1)

14. Unii-bg7hlx2919

15. Kisqali (tn)

16. Lee011 (succinate)

17. Birociclib [who-dd]

18. Schembl2684999

19. Chembl3707266

20. Ribociclib Succinate [mi]

21. Dtxsid301027923

22. Amy25508

23. Bcp12715

24. Ex-a1586

25. Zec63975

26. Lee011 Succinatelee011 Succinate

27. Hy-15777b

28. S5188

29. Ribociclib Succinate [who-dd]

30. Sb18482

31. Ac-30654

32. As-75241

33. Ribociclib Succinate [orange Book]

34. D10979

35. Lee-011 Succinate Salt, Ribociclib Succinate Salt

36. J-007026

37. Q27274660

38. Kisqali Femara Co-pack Component Ribociclib Succinate

39. Ribociclib Succinate Component Of Kisqali Femara Co-pack

40. 7-cyclopentyl-n,n-dimethyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}-7h-pyrrolo[2,3-d]pyrimidine-6-carboxamide; Butanedioic Acid

2.4 Create Date

2012-06-20

3 Chemical and Physical Properties

Molecular Formula	C₂₇H₃₆N₈O₅
Molecular Weight	552.6 g/mol
Hydrogen Bond Donor Count	4
Hydrogen Bond Acceptor Count	11
Rotatable Bond Count	8
Exact Mass	552.28086628 g/mol
Monoisotopic Mass	552.28086628 g/mol
Topological Polar Surface Area	166 Å²
Heavy Atom Count	40
Formal Charge	0
Complexity	728
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	KISQALI
Active Ingredient	RIBOCICLIB SUCCINATE
Company	NOVARTIS PHARMS CORP (Application Number: N209092. Patents: 8324225, 8415355, 8685980, 8962630, 9193732, 9416136, 9868739)

2 of 2
Drug Name	KISQALI FEMARA CO-PACK (COPACKAGED)
Active Ingredient	LETROZOLE; RIBOCICLIB SUCCINATE
Company	NOVARTIS PHARMS CORP (Application Number: N209935. Patents: 8324225, 8415355, 8685980, 8962630, 9193732, 9416136, 9868739)

4.2 Drug Indication

Kisqali is indicated for the treatment of women with hormone receptor (HR)positive, human epidermal growth factor receptor 2 (HER2)negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.

In pre or perimenopausal women, the endocrine therapy should be combined with a luteinising hormonereleasing hormone (LHRH) agonist.

5 Pharmacology and Biochemistry

5.1 ATC Code

L01XE

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