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KISQALI FEMARA CO-PACK (COPACKAGED) Drug Profile
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» See Plans and PricingWhen 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 seven patents protecting this drug.
This drug has one hundred and forty-one patent family members in fifty 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: | 141 |
| 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)
| 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, TABLET;ORAL | 209935-001 | May 4, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Novartis | KISQALI FEMARA CO-PACK (COPACKAGED) | letrozole; ribociclib succinate | TABLET, TABLET;ORAL | 209935-001 | May 4, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Novartis | KISQALI FEMARA CO-PACK (COPACKAGED) | letrozole; ribociclib succinate | TABLET, TABLET;ORAL | 209935-001 | May 4, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start 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 KISQALI FEMARA CO-PACK (COPACKAGED)
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 2331547 | Start Trial |
| Japan | 6534375 | Start Trial |
| Cuba | 23831 | 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 | 291 26-2017 | Slovakia | Start Trial | PRODUCT NAME: RIBOCIKLIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1221 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 | 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 |
