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KISQALI FEMARA CO-PACK (COPACKAGED) Drug Profile
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When do Kisqali Femara Co-pack (copackaged) patents expire, and when can generic versions of Kisqali Femara Co-pack (copackaged) launch?
Kisqali Femara Co-pack (copackaged) is a drug marketed by Novartis and is included in one NDA. There are eight patents protecting this drug.
This drug has one hundred and sixty-six patent family members in fifty-one countries.
The generic ingredient in KISQALI FEMARA CO-PACK (COPACKAGED) is letrozole; ribociclib succinate. There are twenty-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the letrozole; ribociclib succinate profile page.
DrugPatentWatch® Generic Entry Outlook for Kisqali Femara Co-pack (copackaged)
Kisqali Femara Co-pack (copackaged) was eligible for patent challenges on March 13, 2021.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 14, 2036. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for KISQALI FEMARA CO-PACK (COPACKAGED)
| International Patents: | 166 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | KISQALI FEMARA CO-PACK (COPACKAGED) at DailyMed |
-patent-expirations.png "KISQALI FEMARA CO-PACK (COPACKAGED) drug patent expirations")
DrugPatentWatch® Estimated Generic Entry Opportunity Date for KISQALI FEMARA CO-PACK (COPACKAGED)
Generic Entry Date for KISQALI FEMARA CO-PACK (COPACKAGED)*:
Constraining patent/regulatory exclusivity:
NDA:
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.
US Patents and Regulatory Information for KISQALI FEMARA CO-PACK (COPACKAGED)
International Patents for KISQALI FEMARA CO-PACK (COPACKAGED)
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Cuba | 20080223 | Start Trial |
| China | 101594871 | Start Trial |
| Australia | 2017221805 | Start Trial |
| Argentina | 061124 | Start Trial |
| Japan | 2013542257 | Start Trial |
| Portugal | 2029145 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for KISQALI FEMARA CO-PACK (COPACKAGED)
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2331547 | 66/2017 | Austria | Start Trial | PRODUCT NAME: RIBOCICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1221 (MITTEILUNG) 20170824 |
| 2331547 | CR 2017 00060 | Denmark | Start Trial | PRODUCT NAME: RIBOCICLIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/17/1221 20170824 |
| 2331547 | 132017000142645 | Italy | Start Trial | PRODUCT NAME: RIBOCICLIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(KISQALI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1221, 20170824 |
| 2331547 | LUC00048 | Luxembourg | Start Trial | PRODUCT NAME: RIBOCICLIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/171221 20170824 |
| 2331547 | C20170039 00245 | Estonia | Start Trial | PRODUCT NAME: RIBOTSIKLIIB;REG NO/DATE: EU/1/17/1221 24.08.2017 |
| 2331547 | 2017C/052 | Belgium | Start Trial | PRODUCT NAME: KISQALI - RIBOCOCLIB; AUTHORISATION NUMBER AND DATE: EU/1/17/1221 20170824 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
