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Last Updated: February 26, 2024

KISQALI FEMARA CO-PACK (COPACKAGED) Drug Patent Profile


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When do Kisqali Femara Co-pack (copackaged) patents expire, 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 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

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Drug patent expirations by year for KISQALI FEMARA CO-PACK (COPACKAGED)
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.

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

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Novartis KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 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
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) ⤷  Try a Trial
Argentina 073116 COMPUESTOS DE PIRROLO[2,3-D]-PIRIMIDINA MODULADORES DE PROTEINQUINASAS CDK, COMPOSICIONES FARMACEUTICAS QUE LOS CONTIENEN Y USO DE LOS MISMOS EN EL TRATAMIENTO Y/O PREVENCION DE CANCER Y ENFERMEDADES AUTOINMUNES. ⤷  Try a Trial
San Marino AP200800069 Composti pirrolopirimidinici e loro usi ⤷  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 CR 2017 00060 Denmark ⤷  Try a Trial PRODUCT NAME: RIBOCICLIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/17/1221 20170824
2331547 SPC/GB17/074 United Kingdom ⤷  Try a Trial PRODUCT NAME: RIBOCICLIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/17/1221/001-012 20170824; UK PLGB 00101/1100 20170824
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Dow
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Express Scripts
Baxter

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.