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 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
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Novartis | KISQALI FEMARA CO-PACK (COPACKAGED) | letrozole; ribociclib succinate | TABLET;ORAL | 209935-001 | May 4, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | KISQALI FEMARA CO-PACK (COPACKAGED) | letrozole; ribociclib succinate | TABLET;ORAL | 209935-001 | May 4, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | KISQALI FEMARA CO-PACK (COPACKAGED) | letrozole; ribociclib succinate | TABLET;ORAL | 209935-001 | May 4, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 |
|---|---|---|---|
| Argentina | 073116 | COMPUESTOS DE PIRROLO[2,3-D]-PIRIMIDINA MODULADORES DE PROTEINQUINASAS CDK, COMPOSICIONES FARMACEUTICAS QUE LOS CONTIENEN Y USO DE LOS MISMOS EN EL TRATAMIENTO Y/O PREVENCION DE CANCER Y ENFERMEDADES AUTOINMUNES. | ⤷ Sign Up |
| European Patent Office | 2331547 | COMPOSÉS DE PYRROLOPYRIMIDINE ET LEURS UTILISATIONS (PYRROLOPYRIMIDINE COMPOUNDS AS CDK INHIBITORS) | ⤷ Sign Up |
| Mexico | 2011001879 | COMPUESTOS DE PIRROLO-PIRIMIDINA COMO INHIBIDORES DE CDK. (PYRROLOPYRIMIDINE COMPOUNDS AS CDK INHIBITORS.) | ⤷ Sign Up |
| Portugal | 2331547 | ⤷ 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 | PA2017039,C2331547 | Lithuania | ⤷ Sign Up | PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822 |
| 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 |
| 2331547 | LUC00048 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: RIBOCICLIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/171221 20170824 |
| 2331547 | 1790067-1 | Sweden | ⤷ Sign Up | PRODUCT NAME: RIBOCICLIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/17/1221 20170824 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
