KISQALI FEMARA CO-PACK (COPACKAGED) Drug Patent Profile
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Which patents cover Kisqali Femara Co-pack (copackaged), and what generic alternatives are available?
Kisqali Femara Co-pack (copackaged) is a drug marketed by Novartis and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and eighty-three 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 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
Summary for KISQALI FEMARA CO-PACK (COPACKAGED)
International Patents: | 183 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Formulation / Manufacturing: | see details |
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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for KISQALI FEMARA CO-PACK (COPACKAGED)
Generic Entry Date for KISQALI FEMARA CO-PACK (COPACKAGED)*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, 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.
Anatomical Therapeutic Chemical (ATC) Classes for KISQALI FEMARA CO-PACK (COPACKAGED)
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 eleven US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of KISQALI FEMARA CO-PACK (COPACKAGED) is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pyrrolopyrimidine compounds and their uses
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pyrrolopyrimidine compounds and their uses
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pyrrolopyrimidine compounds and their uses
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pyrrolopyrimidine compounds and their uses
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pyrrolopyrimidine compounds and their uses
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
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
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 16248017
Estimated Expiration: ⤷ Try a Trial
Patent: 19201929
Estimated Expiration: ⤷ Try a Trial
Patent: 20250190
Estimated Expiration: ⤷ Try a Trial
Patent: 22215155
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2017021283
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 82425
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 17002593
Estimated Expiration: ⤷ Try a Trial
China
Patent: 7530292
Estimated Expiration: ⤷ Try a Trial
Patent: 5554257
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 17010510
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0230053
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 83058
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 17075052
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 1792290
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 83058
Estimated Expiration: ⤷ Try a Trial
Patent: 97530
Estimated Expiration: ⤷ Try a Trial
Finland
Patent: 83058
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 61213
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 18514523
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 17013350
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 180035
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 017501820
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 83058
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 83058
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201708084P
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 83058
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 170137101
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 38261
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 1642864
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 17000422
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
European Patent Office | 2716643 | Composés de la pyrazolopyrimidine et ses utilisations (Pyrrolopyrimidine compounds and their uses) | ⤷ Try a Trial |
China | 107530292 | 瑞博西尼片剂 (Ribociclib tablet) | ⤷ Try a Trial |
South Korea | 20110052713 | PYRROLOPYRIMIDINE COMPOUNDS AS CDK INHIBITORS | ⤷ Try a Trial |
Spain | 2623133 | ⤷ Try a Trial | |
>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 | C20170039 00245 | Estonia | ⤷ Try a Trial | PRODUCT NAME: RIBOTSIKLIIB;REG NO/DATE: EU/1/17/1221 24.08.2017 |
2331547 | 122017000102 | Germany | ⤷ Try a Trial | PRODUCT NAME: RIBOCICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON.; REGISTRATION NO/DATE: EU/1/17/1221 20170822 |
2331547 | 66/2017 | Austria | ⤷ Try a Trial | PRODUCT NAME: RIBOCICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1221 (MITTEILUNG) 20170824 |
0236940 | 97C0053 | Belgium | ⤷ Try a Trial | PRODUCT NAME: LETROZOLE; NAT. REGISTRATION NO/DATE: 206 IS 241 F 3 19970616; FIRST REGISTRATION: FR 341 474.2 1996072 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |