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Last Updated: November 22, 2019

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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 and is included in two NDAs. There are seven patents protecting this drug.

This drug has one hundred and thirty-seven 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
Drug patent expirations by year for KISQALI
Drug Prices for KISQALI

See drug prices for KISQALI

Generic Entry Opportunity Date for KISQALI
Generic Entry Date for KISQALI*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for KISQALI

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SponsorPhase
Novartis PharmaceuticalsPhase 2
NovartisPhase 3
West German Study GroupPhase 3

See all KISQALI clinical trials

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

Supplementary Protection Certificates for KISQALI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2331547 C20170039 00245 Estonia   Start Trial PRODUCT NAME: RIBOTSIKLIIB;REG NO/DATE: EU/1/17/1221 24.08.2017
2331547 PA2017039,C2331547 Lithuania   Start Trial PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822
2331547 2017C/052 Belgium   Start Trial PRODUCT NAME: KISQALI - RIBOCOCLIB; AUTHORISATION NUMBER AND DATE: EU/1/17/1221 20170824
2331547 C201730045 Spain   Start Trial 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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