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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Letrozole; ribociclib succinate has one hundred and eighty-four patent family members in fifty-three countries.
One supplier is listed for this compound.
Summary for letrozole; ribociclib succinate
| International Patents: | 184 |
| US Patents: | 8 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for letrozole; ribociclib succinate |
| DailyMed Link: | letrozole; ribociclib succinate at DailyMed |
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
International Patents for letrozole; ribociclib succinate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Peru | 20140065 | SAL(ES) DE DIMETIL-AMIDA DEL ACIDO 7-CICLOPENTIL-2-(5-PIPERAZIN-1-IL-PIRIDIN-2-IL-AMINO)-7H-PIRROLO-[2,3-D]-PIRIMIDIN-6-CARBOXILICO Y PROCESOS PARA SU ELABORACION | ⤷ Try a Trial |
| Canada | 2652044 | COMPOSES DE PYRROLOPYRIMIDINE ET LEURS UTILISATIONS (PYRROLOPYRIMIDINE COMPOUNDS AND THEIR USES) | ⤷ Try a Trial |
| Taiwan | I549953 | ⤷ Try a Trial | |
| Finland | 3283058 | ⤷ Try a Trial | |
| European Patent Office | 3283058 | COMPRIMÉ DE RIBOCICLIB (RIBOCICLIB TABLET) | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2007140222 | ⤷ Try a Trial | |
| China | 115554257 | 瑞博西尼片剂 (Ribociclib tablet) | ⤷ 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 | 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 |
| 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 | 122017000102 | Germany | ⤷ Try a Trial | PRODUCT NAME: RIBOCICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON.; REGISTRATION NO/DATE: EU/1/17/1221 20170822 |
| 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 | PA2017039,C2331547 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822 |
| 2331547 | LUC00048 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: RIBOCICLIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/171221 20170824 |
| 2331547 | 291 26-2017 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: RIBOCIKLIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1221 20170824 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
