KISQALI FEMARA CO-PACK (COPACKAGED) Drug Patent Profile
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Which patents cover Kisqali Femara Co-pack (copackaged), and when can generic versions of Kisqali Femara Co-pack (copackaged) launch?
Kisqali Femara Co-pack (copackaged) is a drug marketed by Novartis and is included in one NDA. 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 FEMARA CO-PACK (COPACKAGED) 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 Femara Co-pack (copackaged)
Kisqali Femara Co-pack (copackaged) 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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Summary for KISQALI FEMARA CO-PACK (COPACKAGED)
| International Patents: | 184 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for KISQALI FEMARA CO-PACK (COPACKAGED) |
| DailyMed Link: | KISQALI FEMARA CO-PACK (COPACKAGED) at DailyMed |
-patent-expirations.png "KISQALI FEMARA CO-PACK (COPACKAGED) drug patent expirations")
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for KISQALI FEMARA CO-PACK (COPACKAGED)
*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.
Paragraph IV (Patent) Challenges for KISQALI FEMARA CO-PACK (COPACKAGED)
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| KISQALI FEMARA CO-PACK (COPACKAGED) | Tablets | letrozole; ribociclib succinate | 200 mg and 2.5 mg | 209935 | 4 | 2021-03-15 |
US Patents and Regulatory Information for KISQALI FEMARA CO-PACK (COPACKAGED)
KISQALI FEMARA CO-PACK (COPACKAGED) is protected by fifteen US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of KISQALI FEMARA CO-PACK (COPACKAGED) 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 FEMARA CO-PACK (COPACKAGED)
Ribociclib tablet
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: TREATMENT OF PRE/PERIMENOPAUSAL WOMEN 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: ADJUVANT TREATMENT OF ADULTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE STAGE II AND III EARLY BREAST CANCER AT HIGH RISK OF RECURRENCE
Pyrrolopyrimidine compounds and their uses
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: 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
Pyrrolopyrimidine compounds and their uses
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PRE/PERIMENOPAUSAL WOMEN 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: ADJUVANT TREATMENT OF ADULTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE STAGE II AND III EARLY BREAST CANCER AT HIGH RISK OF RECURRENCE
Pyrrolopyrimidine compounds and their uses
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: 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: ADJUVANT TREATMENT OF ADULTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE STAGE II AND III EARLY BREAST CANCER AT HIGH RISK OF RECURRENCE
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: TREATMENT OF PRE/PERIMENOPAUSAL WOMEN 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: 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
FDA Regulatory Exclusivity protecting KISQALI FEMARA CO-PACK (COPACKAGED)
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Sign Up
FOR THE ADJUVANT TREATMENT OF ADULTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2(HER2)-NEGATIVE STAGE II AND III EARLY BREAST CANCER AT HIGH RISK OF RECURRENCE
Exclusivity Expiration: ⤷ Sign Up
International Patents for KISQALI FEMARA CO-PACK (COPACKAGED)
When does loss-of-exclusivity occur for KISQALI FEMARA CO-PACK (COPACKAGED)?
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 FEMARA CO-PACK (COPACKAGED) around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 113956257 | 一种细胞周期调节蛋白依赖性激酶抑制剂的盐及其制备方法 (Salt(s) of cell cycle regulatory protein dependent kinase inhibitor and methods of making thereof) | ⤷ Sign Up |
| Georgia, Republic of | P20135785 | PYRROLOPYRIMIDINE COMPOUNDS AS CDK INHIBITORS | ⤷ Sign Up |
| Mexico | 370852 | SAL (ES) DE DIMETIL-AMIDA DEL ÁCIDO 7-CICLOPENTIL-2- (5-PIPERAZIN-1-IL-PIRIDIN-2-IL-AMINO) -7H-PIRROLO- [2, 3-D]-PIRIMIDIN-6-CARBOXÍLICO Y PROCESOS PARA SU ELABORACIÓN. (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.) | ⤷ Sign Up |
| New Zealand | 591176 | PYRROLOPYRIMIDINE COMPOUNDS AS CDK INHIBITORS | ⤷ Sign Up |
| Japan | 2018514523 | リボシクリブ錠剤 | ⤷ Sign Up |
| Taiwan | 201014858 | Pyrrolopyrimidine compounds and their uses | ⤷ Sign Up |
| Japan | 2013542257 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for KISQALI FEMARA CO-PACK (COPACKAGED)
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2331547 | 300909 | Netherlands | ⤷ Sign Up | PRODUCT NAME: RIBOCICLIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/17/1221 20170824 |
| 2331547 | PA2017039 | Lithuania | ⤷ Sign Up | PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822 |
| 2331547 | 291 26-2017 | Slovakia | ⤷ Sign Up | PRODUCT NAME: RIBOCIKLIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1221 20170824 |
| 2331547 | LUC00048 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: RIBOCICLIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/171221 20170824 |
| 2331547 | CR 2017 00060 | Denmark | ⤷ Sign Up | PRODUCT NAME: RIBOCICLIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/17/1221 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 | 66/2017 | Austria | ⤷ Sign Up | 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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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.
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