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Last Updated: February 19, 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 patent protection?

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 thirty-eight patent family members in forty-nine 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:138
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   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 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 Y Y   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 1790067-1 Sweden   Start Trial PRODUCT NAME: RIBOCICLIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/17/1221 20170824
2331547 C201730045 Spain   Start Trial PRODUCT NAME: RIBOCICLIB O UNA SAL DE ESTE FARMACEUTICAMENTE ACEPTABLE; NATIONAL AUTHORISATION NUMBER: EU/1/17/1221; DATE OF AUTHORISATION: 20170822; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1221; DATE OF FIRST AUTHORISATION IN EEA: 20170822
2331547 66/2017 Austria   Start Trial PRODUCT NAME: RIBOCICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1221 (MITTEILUNG) 20170824
2331547 PA2017039 Lithuania   Start Trial PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822
2331547 2017059 Norway   Start Trial PRODUCT NAME: RIBOSIKLIB ELLER ET; REG. NO/DATE: EU/1/17/1221 20170830
2331547 PA2017039,C2331547 Lithuania   Start Trial PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822
0236940 97C0053 Belgium   Start 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

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