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Generated: May 23, 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 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
Drug patent expirations by year 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.

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

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Supplementary Protection Certificates for KISQALI

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

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