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 nine 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: | 9 |
| 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
*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.
Anatomical Therapeutic Chemical (ATC) Classes for letrozole; ribociclib succinate
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 |
|---|---|---|---|
| Chile | 2007001504 | COMPUESTOS DERIVADOS DE PURINA O PIRROLOPIRIMIDINA; Y USO PARA REGULAR, MODULAR O INHIBIR LA ACTIVIDAD DE LA PROTEINA CINASA EN ENFERMEDADES TALES COMO CANCER, RECHAZO DE TRANSPLANTES Y ENFERMEDADES AUTOINMUNES. | ⤷ Sign Up |
| Argentina | 117799 | SAL(ES) DE DIMETIL-AMIDA DEL ÁCIDO 7-CICLOPENTIL-2-(5-PIPERAZIN-1-IL-PIRIDIN-2-IL-AMINO)-7H-PIRROLO-[2,3-D]-PIRIMIDIN-6-CARBOXÍLICO Y PROCESOS PARA SU ELABORACIÓN | ⤷ Sign Up |
| Cuba | 20080223 | COMPUESTOS DE PIRROLO-PIRIMIDINA Y SUS USOS | ⤷ Sign Up |
| South Korea | 101466412 | ⤷ Sign Up | |
| European Patent Office | 3753933 | SEL SUCCINAT DU DIMETHYLAMIDE DE L'ACIDE 7-CYCLOPENTYL-2-(5-PIPERAZIN-1-YLPYRIDIN-2-YLAMINO)-7H-PYRROLO[2,3-D]PYRIMIDINE-6-CARBOXYLIQUE ET LEURS PROCEDES DE FABRICATION (SUCCINATE SALT 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) | ⤷ Sign Up |
| Uruguay | 38935 | COMPUESTOS DE PIRROLO-PIRIMIDINA Y SUS USOS | ⤷ Sign Up |
| China | 107530292 | 瑞博西尼片剂 (Ribociclib tablet) | ⤷ Sign Up |
| >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 | C20170039 00245 | Estonia | ⤷ Sign Up | PRODUCT NAME: RIBOTSIKLIIB;REG NO/DATE: EU/1/17/1221 24.08.2017 |
| 2331547 | C02331547/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: RIBOCICLIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66377 24.10.2017 |
| 2331547 | 132017000142645 | Italy | ⤷ Sign Up | PRODUCT NAME: RIBOCICLIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(KISQALI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1221, 20170824 |
| 2331547 | CR 2017 00060 | Denmark | ⤷ Sign Up | PRODUCT NAME: RIBOCICLIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/17/1221 20170824 |
| 2331547 | 2017059 | Norway | ⤷ Sign Up | PRODUCT NAME: RIBOSIKLIB ELLER ET; REG. NO/DATE: EU/1/17/1221 20170830 |
| 2331547 | 17C1059 | France | ⤷ Sign Up | PRODUCT NAME: RIBOCICLIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/17/1221 20170824 |
| 2331547 | C201730045 | Spain | ⤷ Sign Up | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
