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KISQALI Drug Profile

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When do Kisqali patents expire, and what generic alternatives are available?

Kisqali is a drug marketed by Novartis Pharms Corp and is included in two NDAs. There are seven patents protecting this drug.

This drug has one hundred and thirty-two patent family members in forty-nine countries.

The generic ingredient in KISQALI is letrozole; ribociclib succinate. There are twenty-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the letrozole; ribociclib succinate profile page.

Summary for KISQALI

International Patents:	132
US Patents:	7
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	57
Clinical Trials:	7
Patent Applications:	97
Drug Prices:	Drug price information for KISQALI
Prior Art and Litigation Support	Order Prior Art and Litigation support for KISQALI
DailyMed Link:	KISQALI at DailyMed

Generic Entry Opportunity Date for KISQALI

NDA:

209092

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 KISQALI

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

Synonyms for KISQALI

1211441-98-3

2513AH

6-(1H-Indazol-6-yl)-N-[4-(4-morpholinyl)phenyl]-Imidazo[1,2-a]pyrazin-8-amine

6ZZ

7-cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo [2,3-d]pyrimidine-6-carboxylic acid dimethylamide

7-cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxylic acid dimethylamide

7-cyclopentyl-N,N-dimethyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide

7-Cyclopentyl-N,N-dimethyl-2-(5-(piperazin-1-yl)pyridin-2-ylamino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide

7-cyclopentyl-N,N-dimethyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide

AC-30029

ACN-040728

AK174906

AKOS025404915

AKOS032949987

AOB87725

AS-10159

AX8322700

BC600363

BCP08804

BDBM148264

CHEMBL3545110

CS-1750

D10883

DB11730

EX-A304

example 74 [US8962630]

FT-0700117

GTPL7383

HMS3653N03

HY-15777

J-690066

KB-308551

KS-0000068T

LEE 011

LEE-011

LEE011

LEE011A

MolPort-035-395-865

NCGC00386317-10

NVP-LEE011

RHXHGRAEPCAFML-UHFFFAOYSA-N

Ribociclib

Ribociclib (LEE011)

Ribociclib (USAN/INN)

Ribociclib [USAN:INN]

Ribociclib, LEE011

Ribociclib(LEE011)

s7440

SB18480

SCHEMBL302310

SW220101-1

SYN1213

TK8ERE8P56

Tube013

UNII-TK8ERE8P56

US8962630, 74

ZINC72316335

US Patents and Regulatory Information for KISQALI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis Pharms Corp	KISQALI	ribociclib succinate	TABLET;ORAL	209092-001	Mar 13, 2017		RX	Yes	Yes
Novartis Pharms Corp	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET, TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes
Novartis Pharms Corp	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET, TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes
Novartis Pharms Corp	KISQALI	ribociclib succinate	TABLET;ORAL	209092-001	Mar 13, 2017		RX	Yes	Yes
Novartis Pharms Corp	KISQALI	ribociclib succinate	TABLET;ORAL	209092-001	Mar 13, 2017		RX	Yes	Yes
Novartis Pharms Corp	KISQALI	ribociclib succinate	TABLET;ORAL	209092-001	Mar 13, 2017		RX	Yes	Yes			Y	Y
Novartis Pharms Corp	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET, TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes			Y	Y

International Patents for KISQALI

Country	Patent Number	Estimated Expiration
Uruguay	32067
Taiwan	200815011
Taiwan	I468409
Singapore	189229
Uruguay	30369
Japan	2012500785
Mexico	2008015076

Supplementary Protection Certificates for KISQALI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2331547	66/2017	Austria		PRODUCT NAME: RIBOCICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1221 (MITTEILUNG) 20170824
2331547	CR 2017 00060	Denmark		PRODUCT NAME: RIBOCICLIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/17/1221 20170824
2331547	2017/060	Ireland		PRODUCT NAME: RIBOCICLIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/17/1221 20170824
2331547	C201730045	Spain		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
2331547	PA2017039	Lithuania		PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822
2331547	PA2017039,C2331547	Lithuania		PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822
2331547	291 26-2017	Slovakia		PRODUCT NAME: RIBOCIKLIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1221 20170824