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.

Summary for ribociclib succinate

International Patents:	184
US Patents:	9
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				⤷ 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				⤷ 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	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
Chile	2007001504	COMPUESTOS DERIVADOS DE PURINA O PIRROLOPIRIMIDINA; Y USO PARA REGULAR, MODULAR O INHIBIR LA ACTIVIDAD DE LA PROTEINA CINASA EN ENFERMEDADES TALES COMO CANCER, RECHAZO DE TRANSPLANTES Y ENFERMEDADES AUTOINMUNES.	⤷ Sign Up
Argentina	117799	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
Cuba	20080223	COMPUESTOS DE PIRROLO-PIRIMIDINA Y SUS USOS	⤷ Sign Up
South Korea	101466412		⤷ Sign Up
European Patent Office	3753933	SEL SUCCINAT 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 (SUCCINATE SALT 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
Uruguay	38935	COMPUESTOS DE PIRROLO-PIRIMIDINA Y SUS USOS	⤷ Sign Up
China	107530292	瑞博西尼片剂 (Ribociclib tablet)	⤷ 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	66/2017	Austria	⤷ Sign Up	PRODUCT NAME: RIBOCICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1221 (MITTEILUNG) 20170824
2331547	132017000142645	Italy	⤷ Sign Up	PRODUCT NAME: RIBOCICLIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(KISQALI); AUTHORISATION NUMBER(S) AND DATE(S): 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	122017000102	Germany	⤷ Sign Up	PRODUCT NAME: RIBOCICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON.; REGISTRATION NO/DATE: EU/1/17/1221 20170822
2331547	C02331547/01	Switzerland	⤷ Sign Up	PRODUCT NAME: RIBOCICLIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66377 24.10.2017
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	PA2017039,C2331547	Lithuania	⤷ Sign Up	PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822
>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.