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Last Updated: June 3, 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 eight 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.

Summary for ribociclib succinate

International Patents:	184
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Patent Applications:	89
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ribociclib succinate
DailyMed Link:	ribociclib succinate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ribociclib succinate

Generic Entry Date for ribociclib succinate^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 3A Inhibitors Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ribociclib succinate

L01EF	Cyclin-dependent kinase (CDK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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

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Glossary

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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			⤷ 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
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
>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

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Country	Patent Number	Title	Estimated Expiration
Argentina	108179	COMPUESTOS DE PIRROLO[2,3-D]PIRIMIDINA Y SUS USOS PARA EL TRATAMIENTO DE DIVERSOS TIPOS DE CÁNCER POR MEDIO DE LA MODULACIÓN DE LA ACTIVIDAD DE LA CINASA DE PROTEÍNA TIROSINA	⤷ Sign Up
Morocco	34653	SELS DU DIMETHYLAMIDE DE L'ACIDE 7-CYCLOPENTYL-2-(5-PIPERAZIN-1-YLPYRIDIN-2-YLAMINO)-7H-PYRROLO[2,3-D]PYRIMIDINE-6-CARBOXYLIQUE ET LEURS PROCEDES DE FABRICATION	⤷ Sign Up
Colombia	6781544	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.	⤷ Sign Up
Guatemala	200800258	COMPUESTOS DE PIRROLO-PIRIMIDINA Y SUS USOS	⤷ Sign Up
Japan	5560496		⤷ Sign Up
Brazil	PI0917791	compostos de pirrolopirimidina como inibidores de cdk	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ribociclib succinate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2331547	291 26-2017	Slovakia	⤷ Sign Up	PRODUCT NAME: RIBOCIKLIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1221 20170824
2331547	LUC00048	Luxembourg	⤷ Sign Up	PRODUCT NAME: RIBOCICLIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/171221 20170824
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	SPC/GB17/074	United Kingdom	⤷ Sign Up	PRODUCT NAME: RIBOCICLIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/17/1221/001-012 20170824; UK PLGB 00101/1100 20170824
2331547	66/2017	Austria	⤷ Sign Up	PRODUCT NAME: RIBOCICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1221 (MITTEILUNG) 20170824
2331547	C201730045	Spain	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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