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Last Updated: February 2, 2023

Ribociclib succinate - Generic Drug Details


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What are the generic drug sources for ribociclib succinate and what is the scope of patent protection?

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

Ribociclib succinate has one hundred and seventy-two patent family members in fifty-one countries.

One supplier is listed for this compound.

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis KISQALI ribociclib succinate TABLET;ORAL 209092-001 Mar 13, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Novartis KISQALI ribociclib succinate TABLET;ORAL 209092-001 Mar 13, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Cuba 23831 COMPUESTOS DE PIRROLO-PIRIMIDINA See Plans and Pricing
Singapore 189229 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 See Plans and Pricing
Mexico 2013005292 SAL (ES) DE DIMETIL-AMIDA DEL ACIDO 7-CICLOPENTIL-2- (5-PIPERAZIN-1-IL-PIRIDIN-2-IL-AMINO) -7H-PIRROLO- [2, 3-D]-PIRIMIDIN-6-CARBOXILICO Y PROCESOS PARA SU ELABORACION. (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.) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ribociclib succinate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2331547 17C1059 France See Plans and Pricing PRODUCT NAME: RIBOCICLIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/17/1221 20170824
2331547 C02331547/01 Switzerland See Plans and Pricing PRODUCT NAME: RIBOCICLIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66377 24.10.2017
2331547 C20170039 00245 Estonia See Plans and Pricing PRODUCT NAME: RIBOTSIKLIIB;REG NO/DATE: EU/1/17/1221 24.08.2017
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Merck
Johnson and Johnson
McKesson
AstraZeneca
Dow

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.