Ribociclib succinate - Generic Drug Details

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 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

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

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			Y
Novartis	KISQALI	ribociclib succinate	TABLET;ORAL	209092-001	Mar 13, 2017		RX	Yes	Yes			Y	Y
Novartis	KISQALI	ribociclib succinate	TABLET;ORAL	209092-001	Mar 13, 2017		RX	Yes	Yes
Novartis	KISQALI	ribociclib succinate	TABLET;ORAL	209092-001	Mar 13, 2017		RX	Yes	Yes			Y	Y

International Patents for ribociclib succinate

Country	Patent Number	Title	Estimated Expiration
Australia	2011326620	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
Slovenia	3283058
Australia	2018274883	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
Argentina	083797	SUCCINATO DE DIMETIL-AMIDA DEL ACIDO 7-CICLOPENTIL-2-(5-PIPERAZIN-1-IL-PIRIDIN-2-IL-AMINO)-7H-PIRROLO-[2,3-D]PIRIMIDIN-6-CARBOXILICO, PROCESO PARA PREPARARLA, INTERMEDIARIOS DE DICHA SINTESIS Y PROCESO DE PREPARACION DE LOS MISMOS

Supplementary Protection Certificates for ribociclib succinate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2331547	17C1059	France		PRODUCT NAME: RIBOCICLIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/17/1221 20170824
2331547	1790067-1	Sweden		PRODUCT NAME: RIBOCICLIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/17/1221 20170824
2331547	664	Finland
2331547	PA2017039,C2331547	Lithuania		PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822