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-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.
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Novartis | KISQALI FEMARA CO-PACK (COPACKAGED) | letrozole; ribociclib succinate | TABLET;ORAL | 209935-001 | May 4, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Novartis | KISQALI FEMARA CO-PACK (COPACKAGED) | letrozole; ribociclib succinate | TABLET;ORAL | 209935-001 | May 4, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Novartis | KISQALI FEMARA CO-PACK (COPACKAGED) | letrozole; ribociclib succinate | TABLET;ORAL | 209935-001 | May 4, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| >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 |
|---|---|---|---|
| Australia | 2009284098 | Pyrrolopyrimidine compounds as CDK inhibitors | ⤷ Try a Trial |
| Mexico | 2017013350 | COMPRIMIDO DE RIBOCICLIB. (RIBOCICLIB TABLET.) | ⤷ Try a Trial |
| European Patent Office | 2716643 | Composés de la pyrazolopyrimidine et ses utilisations (Pyrrolopyrimidine compounds and their uses) | ⤷ Try a Trial |
| Lithuania | PA2017039 | ⤷ 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 | SPC/GB17/074 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: RIBOCICLIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/17/1221/001-012 20170824; UK PLGB 00101/1100 20170824 |
| 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 | 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 |
