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Last Updated: February 23, 2020

DrugPatentWatch Database Preview

KISQALI FEMARA CO-PACK (COPACKAGED) Drug Profile


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Which 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

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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
Drug patent expirations by year for KISQALI FEMARA CO-PACK (COPACKAGED)
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
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   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.