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KISQALI FEMARA CO-PACK (COPACKAGED) Drug Profile
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See Plans and PricingWhich patents cover Kisqali Femara Co-pack (copackaged), and what generic alternatives are available?
Kisqali Femara Co-pack (copackaged) is a drug marketed by Novartis and is included in one NDA. There are seven patents protecting this drug.
This drug has one hundred and thirty-eight patent family members in forty-nine 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.
US ANDA Litigation and Generic Entry Outlook for Kisqali Femara Co-pack (copackaged)
Kisqali Femara Co-pack (copackaged) will be eligible for patent challenges on March 13, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be November 9, 2031. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for KISQALI FEMARA CO-PACK (COPACKAGED)
| International Patents: | 138 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| 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")
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 |
|---|---|---|
| South Korea | 101466412 | Start Trial |
| Peru | 20110419 | Start Trial |
| European Patent Office | 2716643 | Start Trial |
| South Korea | 101353857 | Start Trial |
| Tunisia | SN08481 | 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 | 122017000102 | Germany | Start Trial | PRODUCT NAME: RIBOCICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON.; REGISTRATION NO/DATE: EU/1/17/1221 20170822 |
| 2331547 | 2017059 | Norway | Start Trial | PRODUCT NAME: RIBOSIKLIB ELLER ET; REG. NO/DATE: EU/1/17/1221 20170830 |
| 2331547 | C02331547/01 | Switzerland | Start Trial | PRODUCT NAME: RIBOCICLIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66377 24.10.2017 |
| 2331547 | PA2017039 | Lithuania | Start Trial | PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822 |
| 2331547 | 1790067-1 | Sweden | Start Trial | PRODUCT NAME: RIBOCICLIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/17/1221 20170824 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
