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 nine 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 five 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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Questions you can ask:
- What is the 5 year forecast for KISQALI?
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Summary for KISQALI
International Patents: | 184 |
US Patents: | 9 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 140 |
Clinical Trials: | 35 |
Patent Applications: | 921 |
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-seven US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of KISQALI is ⤷ Subscribe.
This potential generic entry date is based on patent 10,799,506.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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: ⤷ Subscribe
Australia
Patent: 16248017
Patent: Ribociclib tablet
Estimated Expiration: ⤷ Subscribe
Patent: 19201929
Patent: Ribociclib tablet
Estimated Expiration: ⤷ Subscribe
Patent: 20250190
Patent: Ribociclib tablet
Estimated Expiration: ⤷ Subscribe
Patent: 22215155
Patent: Ribociclib tablet
Estimated Expiration: ⤷ Subscribe
Brazil
Patent: 2017021283
Patent: comprimido de ribociclib
Estimated Expiration: ⤷ Subscribe
Canada
Patent: 82425
Patent: COMPRIME DE RIBOCICLIB (RIBOCICLIB TABLET)
Estimated Expiration: ⤷ Subscribe
Chile
Patent: 17002593
Patent: Tableta de ribociclib.
Estimated Expiration: ⤷ Subscribe
China
Patent: 7530292
Patent: 瑞博西尼片剂 (Ribociclib tablet)
Estimated Expiration: ⤷ Subscribe
Patent: 5554257
Patent: 瑞博西尼片剂 (Ribociclib tablet)
Estimated Expiration: ⤷ Subscribe
Colombia
Patent: 17010510
Patent: Tableta de ribociclib
Estimated Expiration: ⤷ Subscribe
Croatia
Patent: 0230053
Estimated Expiration: ⤷ Subscribe
Denmark
Patent: 83058
Estimated Expiration: ⤷ Subscribe
Ecuador
Patent: 17075052
Patent: Tableta de Ribociclib
Estimated Expiration: ⤷ Subscribe
Eurasian Patent Organization
Patent: 1792290
Patent: ТАБЛЕТКА, СОДЕРЖАЩАЯ РИБОЦИКЛИБ
Estimated Expiration: ⤷ Subscribe
European Patent Office
Patent: 83058
Patent: COMPRIMÉ DE RIBOCICLIB (RIBOCICLIB TABLET)
Estimated Expiration: ⤷ Subscribe
Patent: 97530
Patent: COMPRIMÉ DE RIBOCICLIB (RIBOCICLIB TABLET)
Estimated Expiration: ⤷ Subscribe
Finland
Patent: 83058
Estimated Expiration: ⤷ Subscribe
Hungary
Patent: 61213
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 18514523
Patent: リボシクリブ錠剤
Estimated Expiration: ⤷ Subscribe
Mexico
Patent: 17013350
Patent: COMPRIMIDO DE RIBOCICLIB. (RIBOCICLIB TABLET.)
Estimated Expiration: ⤷ Subscribe
Peru
Patent: 180035
Patent: TABLETA DE RIBOCICLIB
Estimated Expiration: ⤷ Subscribe
Philippines
Patent: 017501820
Patent: RIBOCICLIB TABLET
Estimated Expiration: ⤷ Subscribe
Poland
Patent: 83058
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 83058
Estimated Expiration: ⤷ Subscribe
Singapore
Patent: 201708084P
Patent: RIBOCICLIB TABLET
Estimated Expiration: ⤷ Subscribe
Slovenia
Patent: 83058
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 170137101
Patent: 리보시클립 정제
Estimated Expiration: ⤷ Subscribe
Spain
Patent: 38261
Estimated Expiration: ⤷ Subscribe
Taiwan
Patent: 1642864
Patent: RIBOCICLIB tablet
Estimated Expiration: ⤷ Subscribe
Tunisia
Patent: 17000422
Patent: RIBOCICLIB TABLET
Estimated Expiration: ⤷ Subscribe
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 |
---|---|---|---|
Israel | 195086 | תרכובות פירולופירימידין ושימושיהן (Pyrrolopyrimidine compounds and their uses) | ⤷ Subscribe |
Argentina | 108179 | COMPUESTOS DE PIRROLO[2,3-D]PIRIMIDINA Y SUS USOS PARA EL TRATAMIENTO DE DIVERSOS TIPOS DE CÁNCER POR MEDIO DE LA MODULACIÓN DE LA ACTIVIDAD DE LA CINASA DE PROTEÍNA TIROSINA | ⤷ Subscribe |
Georgia, Republic of | P20115283 | PYRROLOPYRIMIDINE COMPOUNDS AND THEIR USES | ⤷ Subscribe |
San Marino | AP200800069 | Composti pirrolopirimidinici e loro usi | ⤷ Subscribe |
Peru | 20080263 | COMPUESTOS DE PIRROLO-PIRIMIDINA Y SUS USOS | ⤷ Subscribe |
Japan | 2017039757 | 7−シクロペンチル−2−(5−ピペラジン−1−イル−ピリジン−2−イルアミノ)−7H−ピロロ[2,3−D]ピリミジン−6−カルボン酸ジメチルアミドの塩およびその製造方法 (SALT 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) | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for KISQALI
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2331547 | 2017/060 | Ireland | ⤷ Subscribe | PRODUCT NAME: RIBOCICLIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/17/1221 20170824 |
2331547 | 17C1059 | France | ⤷ Subscribe | PRODUCT NAME: RIBOCICLIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/17/1221 20170824 |
2331547 | 2017C/052 | Belgium | ⤷ Subscribe | PRODUCT NAME: KISQALI - RIBOCOCLIB; AUTHORISATION NUMBER AND DATE: EU/1/17/1221 20170824 |
2331547 | 664 | Finland | ⤷ Subscribe | |
2331547 | PA2017039 | Lithuania | ⤷ Subscribe | PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822 |
2331547 | C201730045 | Spain | ⤷ Subscribe | 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 |
KISQALI Market Analysis and Financial Projection Experimental
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