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Last Updated: March 18, 2024

Letrozole; ribociclib succinate - Generic Drug Details


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What are the generic drug 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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for letrozole; ribociclib succinate
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for letrozole; ribociclib succinate
Generic Entry Date for letrozole; ribociclib succinate*:
Constraining patent/regulatory exclusivity:
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 LETROZOLE; RIBOCICLIB SUCCINATE
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 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;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 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
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 Y Y ⤷  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 letrozole; ribociclib succinate

Country Patent Number Title Estimated Expiration
Slovenia 2331547 ⤷  Try a Trial
European Patent Office 2029145 COMPOSÉS DE PYRROLOPYRIMIDINE ET LEURS UTILISATIONS (PYRROLOPYRIMIDINE COMPOUNDS AND THEIR USES) ⤷  Try a Trial
Netherlands 300909 ⤷  Try a Trial
Ecuador SP17075052 Tableta de Ribociclib ⤷  Try a Trial
Morocco 32555 مركبات من البيرولوبيريميدين واستخداماتها ⤷  Try a Trial
Cuba 24062 COMPUESTOS DE PIRROLOPIRIMIDINA COMO INHIBIDORES CDK ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for letrozole; ribociclib succinate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2331547 C02331547/01 Switzerland ⤷  Try a Trial PRODUCT NAME: RIBOCICLIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66377 24.10.2017
2331547 C20170039 00245 Estonia ⤷  Try a Trial PRODUCT NAME: RIBOTSIKLIIB;REG NO/DATE: EU/1/17/1221 24.08.2017
2331547 17C1059 France ⤷  Try a Trial PRODUCT NAME: RIBOCICLIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/17/1221 20170824
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 2017/060 Ireland ⤷  Try a Trial PRODUCT NAME: RIBOCICLIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/17/1221 20170824
2331547 132017000142645 Italy ⤷  Try a Trial PRODUCT NAME: RIBOCICLIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(KISQALI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1221, 20170824
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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