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Last Updated: May 26, 2022

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 seventy-one patent family members in fifty-one 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 is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for KISQALI
International Patents:171
US Patents:8
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 82
Clinical Trials: 22
Patent Applications: 1,027
Drug Prices: Drug price information for KISQALI
What excipients (inactive ingredients) are in KISQALI?KISQALI excipients list
DailyMed Link:KISQALI at DailyMed
Drug patent expirations by year for KISQALI
Drug Prices for KISQALI

See drug prices for KISQALI

DrugPatentWatch® Estimated 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
Jonsson Comprehensive Cancer CenterPhase 1/Phase 2
Seagen Inc.Phase 1/Phase 2
SOLTI Breast Cancer Research GroupPhase 2

See all KISQALI clinical trials

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 US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of KISQALI is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pyrrolopyrimidine compounds and their uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pyrrolopyrimidine compounds and their uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pyrrolopyrimidine compounds and their uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pyrrolopyrimidine compounds and their uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pyrrolopyrimidine compounds and their uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Novartis KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Novartis KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis KISQALI ribociclib succinate TABLET;ORAL 209092-001 Mar 13, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis KISQALI ribociclib succinate TABLET;ORAL 209092-001 Mar 13, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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
Estimated Expiration: See Plans and Pricing

Australia

Patent: 16248017
Estimated Expiration: See Plans and Pricing

Patent: 19201929
Estimated Expiration: See Plans and Pricing

Patent: 20250190
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2017021283
Estimated Expiration: See Plans and Pricing

Canada

Patent: 82425
Estimated Expiration: See Plans and Pricing

Chile

Patent: 17002593
Estimated Expiration: See Plans and Pricing

China

Patent: 7530292
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 17010510
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 17075052
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 1792290
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 83058
Estimated Expiration: See Plans and Pricing

Israel

Patent: 4818
Estimated Expiration: See Plans and Pricing

Japan

Patent: 18514523
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 17013350
Estimated Expiration: See Plans and Pricing

Peru

Patent: 180035
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 017501820
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201708084P
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 170137101
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 1642864
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 17000422
Estimated Expiration: See Plans and Pricing

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
Peru 20180035 TABLETA DE RIBOCICLIB See Plans and Pricing
Australia 2007267645 Pyrrolopyrimidine compounds and their uses See Plans and Pricing
Tunisia 2017000422 RIBOCICLIB TABLET See Plans and Pricing
South Africa 201100994 PYRROLOPYRIMIDINE COMPOUNDS AS CDK INHIBITORS See Plans and Pricing
San Marino P200800069 Composti pirrolopirimidinici e loro usi See Plans and Pricing
>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 See Plans and Pricing PRODUCT NAME: RIBOCICLIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/17/1221/001-012 20170824; UK PLGB 00101/1100 20170824
2331547 122017000102 Germany See Plans and Pricing PRODUCT NAME: RIBOCICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON.; REGISTRATION NO/DATE: EU/1/17/1221 20170822
2331547 132017000142645 Italy See Plans and Pricing PRODUCT NAME: RIBOCICLIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(KISQALI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1221, 20170824
2331547 C02331547/01 Switzerland See Plans and Pricing PRODUCT NAME: RIBOCICLIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66377 24.10.2017
2331547 66/2017 Austria See Plans and Pricing PRODUCT NAME: RIBOCICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1221 (MITTEILUNG) 20170824
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Moodys
Dow
Boehringer Ingelheim
Johnson and Johnson
Colorcon

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.