Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Colorcon
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Harvard Business School

Last Updated: December 9, 2019

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Ribociclib succinate - Generic Drug Details

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What are the generic sources for ribociclib succinate and what is the scope of freedom to operate?

Ribociclib succinate is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ribociclib succinate has one hundred and thirty-seven patent family members in forty-nine countries.

One supplier is listed for this compound.

Summary for ribociclib succinate
International Patents:137
US Patents:7
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 27
Patent Applications: 12
DailyMed Link:ribociclib succinate at DailyMed
Pharmacology for ribociclib succinate
Synonyms for ribociclib succinate
1374639-75-4
7-Cyclopentyl-N,N-dimethyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide succinate
ACN-040739
AKOS030526460
AX8323621
BCP12715
BG7HLX2919
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)
CHEMBL3707266
CS-2277
D10979
EX-A1586
HY-15777B
J-007026
Kisqali (TN)
LEE-011 succinate
LEE-011 succinate salt, Ribociclib succinate salt
LEE011 (succinate)
LEE011 succinate
LEE011-BBA
Ribociclib succinate (USAN)
Ribociclib succinate [USAN]
SB18482
SCHEMBL2684999
UNII-BG7HLX2919

US Patents and Regulatory Information for ribociclib succinate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis KISQALI ribociclib succinate TABLET;ORAL 209092-001 Mar 13, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis KISQALI ribociclib succinate TABLET;ORAL 209092-001 Mar 13, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Novartis KISQALI ribociclib succinate TABLET;ORAL 209092-001 Mar 13, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Novartis KISQALI ribociclib succinate TABLET;ORAL 209092-001 Mar 13, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis KISQALI ribociclib succinate TABLET;ORAL 209092-001 Mar 13, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis KISQALI ribociclib succinate TABLET;ORAL 209092-001 Mar 13, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis KISQALI ribociclib succinate TABLET;ORAL 209092-001 Mar 13, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ribociclib succinate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2331547 C201730045 Spain   Start Trial PRODUCT NAME: RIBOCICLIB O UNA SAL DE ESTE FARMACEUTICAMENTE ACEPTABLE; NATIONAL AUTHORISATION NUMBER: EU/1/17/1221; DATE OF AUTHORISATION: 20170822; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1221; DATE OF FIRST AUTHORISATION IN EEA: 20170822
2331547 C20170039 00245 Estonia   Start Trial PRODUCT NAME: RIBOTSIKLIIB;REG NO/DATE: EU/1/17/1221 24.08.2017
2331547 2017C/052 Belgium   Start Trial PRODUCT NAME: KISQALI - RIBOCOCLIB; AUTHORISATION NUMBER AND DATE: EU/1/17/1221 20170824
2331547 PA2017039 Lithuania   Start Trial PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822
2331547 122017000102 Germany   Start Trial PRODUCT NAME: RIBOCICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON.; REGISTRATION NO/DATE: EU/1/17/1221 20170822
2331547 2017/060 Ireland   Start Trial PRODUCT NAME: RIBOCICLIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/17/1221 20170824
2331547 66/2017 Austria   Start Trial PRODUCT NAME: RIBOCICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1221 (MITTEILUNG) 20170824
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Johnson and Johnson
AstraZeneca
Baxter
McKesson
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.