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Last Updated: May 25, 2022

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 seventy-one patent family members in fifty-one 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 is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for KISQALI FEMARA CO-PACK (COPACKAGED)
Drug patent expirations by year for KISQALI FEMARA CO-PACK (COPACKAGED)
DrugPatentWatch® Estimated Generic Entry Opportunity 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 two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of KISQALI FEMARA CO-PACK (COPACKAGED) is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pyrrolopyrimidine compounds and their uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pyrrolopyrimidine compounds and their uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pyrrolopyrimidine compounds and their uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pyrrolopyrimidine compounds and their uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pyrrolopyrimidine compounds and their uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Novartis KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Australia

Patent: 16248017
Estimated Expiration: See Plans and Pricing

Patent: 19201929
Estimated Expiration: See Plans and Pricing

Patent: 20250190
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2017021283
Estimated Expiration: See Plans and Pricing

Canada

Patent: 82425
Estimated Expiration: See Plans and Pricing

Chile

Patent: 17002593
Estimated Expiration: See Plans and Pricing

China

Patent: 7530292
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 17010510
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 17075052
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 1792290
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 83058
Estimated Expiration: See Plans and Pricing

Israel

Patent: 4818
Estimated Expiration: See Plans and Pricing

Japan

Patent: 18514523
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 17013350
Estimated Expiration: See Plans and Pricing

Peru

Patent: 180035
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 017501820
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201708084P
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 170137101
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 1642864
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 17000422
Estimated Expiration: See Plans and Pricing

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 3283058 COMPRIMÉ DE RIBOCICLIB (RIBOCICLIB TABLET) See Plans and Pricing
Australia 2020250190 Ribociclib tablet See Plans and Pricing
Australia 2009284098 Pyrrolopyrimidine compounds as CDK inhibitors See Plans and Pricing
Malaysia 164274 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 See Plans and Pricing
Brazil PI0712816 compostos de pirrolpirimidina e seus usos See Plans and Pricing
Israel 225580 מלח(ים) של חומצה 7-צ'יקלופנטיל-2-(5-פיפראזינ-1-יל-פירידינ-2-ילאמינו)-7h-פירולו[3,2-d] פירימידין-6-קרבוקסילית דימתילאמיד ותהליכים להכנתם (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 them) See Plans and Pricing
>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 17C1059 France See Plans and Pricing PRODUCT NAME: RIBOCICLIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/17/1221 20170824
2331547 122017000102 Germany See Plans and Pricing PRODUCT NAME: RIBOCICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON.; REGISTRATION NO/DATE: EU/1/17/1221 20170822
2331547 2017/060 Ireland See Plans and Pricing PRODUCT NAME: RIBOCICLIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/17/1221 20170824
2331547 PA2017039 Lithuania See Plans and Pricing PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822
2331547 2017059 Norway See Plans and Pricing PRODUCT NAME: RIBOSIKLIB ELLER ET; REG. NO/DATE: EU/1/17/1221 20170830
0236940 97C0053 Belgium See Plans and Pricing 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

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Boehringer Ingelheim
Dow
McKesson
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.