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Last Updated: February 19, 2020

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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-eight patent family members in forty-nine countries.

One supplier is listed for this compound.

Summary for ribociclib succinate
International Patents:138
US Patents:7
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 30
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 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 Y Y   Start Trial
Novartis KISQALI ribociclib succinate TABLET;ORAL 209092-001 Mar 13, 2017 RX Yes Yes   Start Trial   Start Trial   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 PA2017039,C2331547 Lithuania   Start Trial PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822
2331547 17C1059 France   Start Trial PRODUCT NAME: RIBOCICLIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/17/1221 20170824
2331547 CR 2017 00060 Denmark   Start Trial PRODUCT NAME: RIBOCICLIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/17/1221 20170824
2331547 C02331547/01 Switzerland   Start Trial PRODUCT NAME: RIBOCICLIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66377 24.10.2017
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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