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
| International Patents: | 183 |
| 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 |
|---|---|---|---|
| European Patent Office | 2716643 | Composés de la pyrazolopyrimidine et ses utilisations (Pyrrolopyrimidine compounds and their uses) | ⤷ Try a Trial |
| China | 107530292 | 瑞博西尼片剂 (Ribociclib tablet) | ⤷ Try a Trial |
| South Korea | 20110052713 | PYRROLOPYRIMIDINE COMPOUNDS AS CDK INHIBITORS | ⤷ Try a Trial |
| Spain | 2623133 | ⤷ Try a Trial | |
| Cyprus | 1115703 | ⤷ Try a Trial | |
| Portugal | 2331547 | ⤷ Try a Trial | |
| Costa Rica | 20110101 | COMPUESTOS DE PIRROLO-PIRIMIDINA COMO INHIBIDORES DE 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 | C20170039 00245 | Estonia | ⤷ Try a Trial | PRODUCT NAME: RIBOTSIKLIIB;REG NO/DATE: EU/1/17/1221 24.08.2017 |
| 2331547 | 122017000102 | Germany | ⤷ Try a Trial | PRODUCT NAME: RIBOCICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON.; REGISTRATION NO/DATE: EU/1/17/1221 20170822 |
| 2331547 | 66/2017 | Austria | ⤷ Try a Trial | PRODUCT NAME: RIBOCICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1221 (MITTEILUNG) 20170824 |
| 0236940 | 97C0053 | Belgium | ⤷ Try a Trial | PRODUCT NAME: LETROZOLE; NAT. REGISTRATION NO/DATE: 206 IS 241 F 3 19970616; FIRST REGISTRATION: FR 341 474.2 1996072 |
| 2331547 | C02331547/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: RIBOCICLIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66377 24.10.2017 |
| 2331547 | PA2017039 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822 |
| 2331547 | C201730045 | Spain | ⤷ Try a 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
