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 |
---|---|---|---|
Singapore | 11201708084P | RIBOCICLIB TABLET | ⤷ Try a Trial |
Poland | 2029145 | ⤷ Try a Trial | |
Japan | 2018514523 | リボシクリブ錠剤 | ⤷ Try a Trial |
Taiwan | 201014858 | Pyrrolopyrimidine compounds and their uses | ⤷ 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 | 17C1059 | France | ⤷ Try a Trial | PRODUCT NAME: RIBOCICLIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/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 | PA2017039,C2331547 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822 |
2331547 | 2017059 | Norway | ⤷ Try a Trial | PRODUCT NAME: RIBOSIKLIB ELLER ET; REG. NO/DATE: EU/1/17/1221 20170830 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |