KISQALI Drug Patent Profile
✉ Email this page to a colleague
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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for KISQALI?
- What are the global sales for KISQALI?
- What is Average Wholesale Price for KISQALI?
Summary for KISQALI
International Patents: | 184 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 140 |
Clinical Trials: | 35 |
Patent Applications: | 882 |
Drug Prices: | Drug price information for KISQALI |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for KISQALI |
What excipients (inactive ingredients) are in KISQALI? | KISQALI excipients list |
DailyMed Link: | KISQALI at DailyMed |
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
Sponsor | Phase |
---|---|
University of Michigan Rogel Cancer Center | Phase 1 |
AstraZeneca | Phase 1/Phase 2 |
Nationwide Children's Hospital | Phase 2 |
Pharmacology for KISQALI
Drug Class | Kinase Inhibitor |
Mechanism of Action | Cytochrome P450 3A Inhibitors Kinase Inhibitors |
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 |