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-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 |
---|---|---|---|
Croatia | P20170631 | ⤷ 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 |
Ecuador | SP11010843 | COMPUESTOS DE PIRROLO-PIRIMIDINA COMO INHIBIDORES DE CDK | ⤷ Try a Trial |
Japan | 2017057203 | 7−シクロペンチル−2−(5−ピペラジン−1−イル−ピリジン−2−イルアミノ)−7H−ピロロ[2,3−D]ピリミジン−6−カルボン酸ジメチルアミドの塩およびその製造方法 (SALTS 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 THE SAME) | ⤷ 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 | PA2017039,C2331547 | 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 |
2331547 | 1790067-1 | Sweden | ⤷ Try a Trial | PRODUCT NAME: RIBOCICLIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/17/1221 20170824 |
2331547 | C20170039 00245 | Estonia | ⤷ Try a Trial | PRODUCT NAME: RIBOTSIKLIIB;REG NO/DATE: EU/1/17/1221 24.08.2017 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |