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Last Updated: October 5, 2024

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KISQALI Drug Patent Profile


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When do Kisqali patents expire, and when can generic versions of Kisqali launch?

Kisqali is a drug marketed by Novartis and is included in two NDAs. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighty-four patent family members in fifty-three 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.

DrugPatentWatch® Generic Entry Outlook for Kisqali

Kisqali was eligible for patent challenges on March 13, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 14, 2036. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for KISQALI
Drug Prices for KISQALI

See drug prices for KISQALI

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
University of Michigan Rogel Cancer CenterPhase 1
AstraZenecaPhase 1/Phase 2
Nationwide Children's HospitalPhase 2

See all KISQALI clinical trials

Pharmacology for KISQALI
Paragraph IV (Patent) Challenges for KISQALI
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 KISQALI

KISQALI is protected by twenty-three US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of KISQALI is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting KISQALI

Ribociclib tablet
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pyrrolopyrimidine compounds and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pyrrolopyrimidine compounds and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pyrrolopyrimidine compounds and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pyrrolopyrimidine compounds and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: IN COMBINATION WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE-BASED THERAPY FOR TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER-2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER

Pyrrolopyrimidine compounds and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: IN COMBINATION WITH FULVESTRANT FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH HR-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER, AS INITIAL ENDOCRINE BASED THERAPY OR FOLLOWING DISEASE PROGRESSION ON ENDOCRINE THERAPY

Pyrrolopyrimidine compounds and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: IN COMBINATION WITH AN AROMATASE INHIBITOR FOR THE TREATMENT OF PRE/PERIMENOPAUSAL OR POSTMENOPAUSAL WOMEN WITH HR-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER, AS INITIAL ENDOCRINE-BASED THERAPY

Pyrrolopyrimidine compounds and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: IN COMBINATION WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE-BASED THERAPY FOR THE TREATMENT OF ADULT PATIENTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER

Pyrrolopyrimidine compounds and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: IN COMBINATION WITH FULVESTRANT AS INITIAL ENDOCRINE-BASED THERAPY OR FOLLOWING DISEASE PROGRESSION ON ENDOCRINE THERAPY IN POSTMENOPAUSAL WOMEN OR IN MEN, FOR THE TREATMENT OF HR-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER

Pyrrolopyrimidine compounds and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: IN COMBINATION WITH FULVESTRANT AS INITIAL ENDOCRINE-BASED THERAPY OR FOLLOWING DISEASE PROGRESSION ON ENDOCRINE THERAPY, FOR THE TREATMENT OF ADULT PATIENTS WITH HR-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER

Salt(s) 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
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pyrrolopyrimidine compounds and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: IN COMBINATION WITH AN AROMATASE INHIBITOR FOR THE TREATMENT OF PRE/PERIMENOPAUSAL OR POSTMENOPAUSAL WOMEN WITH HR-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER, AS INITIAL ENDOCRINE-BASED THERAPY

Pyrrolopyrimidine compounds and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: IN COMBINATION WITH FULVESTRANT FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH HR-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER, AS INITIAL ENDOCRINE BASED THERAPY OR FOLLOWING DISEASE PROGRESSION ON ENDOCRINE THERAPY

Pyrrolopyrimidine compounds and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: IN COMBINATION WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE-BASED THERAPY FOR TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER-2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER

Pyrrolopyrimidine compounds and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: IN COMBINATION WITH FULVESTRANT AS INITIAL ENDOCRINE-BASED THERAPY OR FOLLOWING DISEASE PROGRESSION ON ENDOCRINE THERAPY IN POSTMENOPAUSAL WOMEN OR IN MEN, FOR THE TREATMENT OF HR-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER

Pyrrolopyrimidine compounds and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: IN COMBINATION WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE-BASED THERAPY FOR THE TREATMENT OF ADULT PATIENTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER

Pyrrolopyrimidine compounds and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: IN COMBINATION WITH FULVESTRANT AS INITIAL ENDOCRINE-BASED THERAPY OR FOLLOWING DISEASE PROGRESSION ON ENDOCRINE THERAPY, FOR THE TREATMENT OF ADULT PATIENTS WITH HR-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER

Salt(s) 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
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: IN COMBINATION WITH AN AROMATASE INHIBITOR FOR THE TREATMENT OF PRE/PERIMENOPAUSAL OR POSTMENOPAUSAL WOMEN WITH HR-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER, AS INITIAL ENDOCRINE-BASED THERAPY

Salt(s) 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
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: IN COMBINATION WITH FULVESTRANT FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH HR-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER, AS INITIAL ENDOCRINE BASED THERAPY OR FOLLOWING DISEASE PROGRESSION ON ENDOCRINE THERAPY

Salt(s) 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
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: IN COMBINATION WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE-BASED THERAPY FOR TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER-2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER

Salt(s) 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
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: IN COMBINATION WITH FULVESTRANT AS INITIAL ENDOCRINE-BASED THERAPY OR FOLLOWING DISEASE PROGRESSION ON ENDOCRINE THERAPY, FOR THE TREATMENT OF ADULT PATIENTS WITH HR-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER

Salt(s) 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
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: IN COMBINATION WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE-BASED THERAPY FOR THE TREATMENT OF ADULT PATIENTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER

Salt(s) 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
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: IN COMBINATION WITH FULVESTRANT AS INITIAL ENDOCRINE-BASED THERAPY OR FOLLOWING DISEASE PROGRESSION ON ENDOCRINE THERAPY IN POSTMENOPAUSAL WOMEN OR IN MEN, FOR THE TREATMENT OF HR-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER

FDA Regulatory Exclusivity protecting KISQALI

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Sign Up

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

When does loss-of-exclusivity occur for KISQALI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 4257
Patent: TABLETA DE RIBOCICLIB
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 16248017
Patent: Ribociclib tablet
Estimated Expiration: ⤷  Sign Up

Patent: 19201929
Patent: Ribociclib tablet
Estimated Expiration: ⤷  Sign Up

Patent: 20250190
Patent: Ribociclib tablet
Estimated Expiration: ⤷  Sign Up

Patent: 22215155
Patent: Ribociclib tablet
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2017021283
Patent: comprimido de ribociclib
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 82425
Patent: COMPRIME DE RIBOCICLIB (RIBOCICLIB TABLET)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 17002593
Patent: Tableta de ribociclib.
Estimated Expiration: ⤷  Sign Up

China

Patent: 7530292
Patent: 瑞博西尼片剂 (Ribociclib tablet)
Estimated Expiration: ⤷  Sign Up

Patent: 5554257
Patent: 瑞博西尼片剂 (Ribociclib tablet)
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 17010510
Patent: Tableta de ribociclib
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0230053
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 83058
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 17075052
Patent: Tableta de Ribociclib
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 1792290
Patent: ТАБЛЕТКА, СОДЕРЖАЩАЯ РИБОЦИКЛИБ
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 83058
Patent: COMPRIMÉ DE RIBOCICLIB (RIBOCICLIB TABLET)
Estimated Expiration: ⤷  Sign Up

Patent: 97530
Patent: COMPRIMÉ DE RIBOCICLIB (RIBOCICLIB TABLET)
Estimated Expiration: ⤷  Sign Up

Finland

Patent: 83058
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 61213
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 18514523
Patent: リボシクリブ錠剤
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 17013350
Patent: COMPRIMIDO DE RIBOCICLIB. (RIBOCICLIB TABLET.)
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 180035
Patent: TABLETA DE RIBOCICLIB
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 017501820
Patent: RIBOCICLIB TABLET
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 83058
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 83058
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201708084P
Patent: RIBOCICLIB TABLET
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 83058
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 170137101
Patent: 리보시클립 정제
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 38261
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 1642864
Patent: RIBOCICLIB tablet
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 17000422
Patent: RIBOCICLIB TABLET
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering KISQALI around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2016166703 ⤷  Sign Up
European Patent Office 3283058 COMPRIMÉ DE RIBOCICLIB (RIBOCICLIB TABLET) ⤷  Sign Up
Ecuador SP17075052 Tableta de Ribociclib ⤷  Sign Up
South Korea 20190099090 7-시클로펜틸-2- 및 그의 제조 방법 (7--2-5--1---2--7-[23-]-6- SALTS OF 7-CYCLOPENTYL-2-5-PIPERAZIN-1-YL-PYRIDIN-2-YLAMINO-7H-PYRROLO[23-D]PYRIMIDINE-6-CARBOXYLIC ACID DIMETHYLAMIDE AND PROCESSES OF MAKING THEREOF) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for KISQALI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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 664 Finland ⤷  Sign Up
2331547 C201730045 Spain ⤷  Sign Up 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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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.