Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Medtronic
Colorcon
Baxter
Dow
Express Scripts

Last Updated: January 24, 2020

DrugPatentWatch Database Preview

KISQALI Drug Profile

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

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-eight 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.

US ANDA Litigation and Generic Entry Outlook for Kisqali

Kisqali will be eligible for patent challenges on March 13, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 9, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

< Available with Subscription >

  Start Trial

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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Novartis PharmaceuticalsPhase 2
Genomic Health®, Inc.Phase 3
NovartisPhase 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   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 FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET, TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes   Start Trial   Start Trial   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 66/2017 Austria   Start Trial PRODUCT NAME: RIBOCICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1221 (MITTEILUNG) 20170824
2331547 CR 2017 00060 Denmark   Start Trial PRODUCT NAME: RIBOCICLIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/17/1221 20170824
2331547 C20170039 00245 Estonia   Start Trial PRODUCT NAME: RIBOTSIKLIIB;REG NO/DATE: EU/1/17/1221 24.08.2017
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Medtronic
AstraZeneca
Moodys
McKinsey
Harvard Business School

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 verifification 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.