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Last Updated: July 6, 2020

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Letrozole; ribociclib succinate - Generic Drug Details

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What are the generic sources for letrozole; ribociclib succinate and what is the scope of freedom to operate?

Letrozole; ribociclib succinate is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Letrozole; ribociclib succinate has one hundred and forty-one patent family members in fifty countries.

There are twenty-four drug master file entries for letrozole; ribociclib succinate. One supplier is listed for this compound.

Summary for letrozole; ribociclib succinate
International Patents:141
US Patents:7
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 24
Suppliers / Packagers: 1
DailyMed Link:letrozole; ribociclib succinate at DailyMed

US Patents and Regulatory Information for letrozole; ribociclib succinate

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, TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Novartis KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET, TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Novartis KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET, TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Novartis KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET, TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET, TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET, TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET, TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for letrozole; ribociclib succinate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2331547 291 26-2017 Slovakia   Start Trial PRODUCT NAME: RIBOCIKLIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1221 20170824
2331547 CR 2017 00060 Denmark   Start Trial PRODUCT NAME: RIBOCICLIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/17/1221 20170824
2331547 2017C/052 Belgium   Start Trial PRODUCT NAME: KISQALI - RIBOCOCLIB; AUTHORISATION NUMBER AND DATE: EU/1/17/1221 20170824
2331547 2017/060 Ireland   Start Trial PRODUCT NAME: RIBOCICLIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/17/1221 20170824
2331547 PA2017039,C2331547 Lithuania   Start Trial PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822
2331547 C20170039 00245 Estonia   Start Trial PRODUCT NAME: RIBOTSIKLIIB;REG NO/DATE: EU/1/17/1221 24.08.2017
2331547 122017000102 Germany   Start Trial PRODUCT NAME: RIBOCICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON.; REGISTRATION NO/DATE: EU/1/17/1221 20170822
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
AstraZeneca
Express Scripts
Harvard Business School
McKesson
Boehringer Ingelheim

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