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Last Updated: November 5, 2024

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 nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ribociclib succinate has one hundred and eighty-four patent family members in fifty-three countries.

One supplier is listed for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ribociclib succinate
Generic Entry Date for ribociclib succinate*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for ribociclib succinate
Paragraph IV (Patent) Challenges for RIBOCICLIB SUCCINATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
KISQALI Tablets ribociclib succinate 200 mg 209092 4 2021-03-15

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

International Patents for ribociclib succinate

Country Patent Number Title Estimated Expiration
China 113956257 一种细胞周期调节蛋白依赖性激酶抑制剂的盐及其制备方法 (Salt(s) of cell cycle regulatory protein dependent kinase inhibitor and methods of making thereof) ⤷  Sign Up
Georgia, Republic of P20135785 PYRROLOPYRIMIDINE COMPOUNDS AS CDK INHIBITORS ⤷  Sign Up
Mexico 370852 SAL (ES) DE DIMETIL-AMIDA DEL ÁCIDO 7-CICLOPENTIL-2- (5-PIPERAZIN-1-IL-PIRIDIN-2-IL-AMINO) -7H-PIRROLO- [2, 3-D]-PIRIMIDIN-6-CARBOXÍLICO Y PROCESOS PARA SU ELABORACIÓN. (SALT(S) OF 7-CYCLOPENTYL-2 -(5-PIPERAZIN-1-YL-PYRIDIN-2-YLAMINO)- 7H-PYRROLO[2,3-D]PYRIMIDINE-6-CARBOXYLIC ACID DIMETHYLAMIDE AND PROCESSES OF MAKING THEREOF.) ⤷  Sign Up
New Zealand 591176 PYRROLOPYRIMIDINE COMPOUNDS AS CDK INHIBITORS ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ribociclib succinate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2331547 PA2017039 Lithuania ⤷  Sign Up PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822
2331547 CR 2017 00060 Denmark ⤷  Sign Up PRODUCT NAME: RIBOCICLIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/17/1221 20170824
2331547 2017/060 Ireland ⤷  Sign Up PRODUCT NAME: RIBOCICLIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/17/1221 20170824
2331547 2017C/052 Belgium ⤷  Sign Up PRODUCT NAME: KISQALI - RIBOCOCLIB; AUTHORISATION NUMBER AND DATE: EU/1/17/1221 20170824
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.