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 |
|---|---|---|---|
| Costa Rica | 20110101 | COMPUESTOS DE PIRROLO-PIRIMIDINA COMO INHIBIDORES DE CDK | ⤷ Try a Trial |
| Japan | 5882371 | ⤷ Try a Trial | |
| South Korea | 20090014219 | PYRROLOPYRIMIDINE COMPOUNDS AND THEIR USES | ⤷ Try a Trial |
| South Africa | 200809382 | PYRROLOPYRIMIDINE COMPOUNDS AND THEIR USES | ⤷ Try a Trial |
| 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) | ⤷ Try a Trial |
| Eurasian Patent Organization | 200802332 | ПИРРОЛОПИРИМИДИНЫ И ИХ ПРИМЕНЕНИЕ | ⤷ 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 | 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 |
| 2331547 | 2017C/052 | Belgium | ⤷ Try a Trial | PRODUCT NAME: KISQALI - RIBOCOCLIB; AUTHORISATION NUMBER AND DATE: EU/1/17/1221 20170824 |
| 2331547 | PA2017039 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822 |
| 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 | CR 2017 00060 | Denmark | ⤷ Try a Trial | PRODUCT NAME: RIBOCICLIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/17/1221 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
