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Last Updated: January 20, 2021

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VERZENIO Drug Profile

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When do Verzenio patents expire, and when can generic versions of Verzenio launch?

Verzenio is a drug marketed by Eli Lilly And Co and is included in one NDA. There is one patent protecting this drug.

This drug has forty-eight patent family members in forty-three countries.

The generic ingredient in VERZENIO is abemaciclib. One supplier is listed for this compound. Additional details are available on the abemaciclib profile page.

US ANDA Litigation and Generic Entry Outlook for Verzenio

Verzenio will be eligible for patent challenges on September 28, 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 December 15, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for VERZENIO
Drug patent expirations by year for VERZENIO
Drug Prices for VERZENIO

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Generic Entry Opportunity Date for VERZENIO
Generic Entry Date for VERZENIO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
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.

Recent Clinical Trials for VERZENIO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
M.D. Anderson Cancer CenterPhase 1/Phase 2
Stanford UniversityPhase 2
Zeno Alpha Inc.Phase 1

See all VERZENIO clinical trials

Pharmacology for VERZENIO
Drug ClassKinase Inhibitor
Mechanism of ActionKinase Inhibitors

US Patents and Regulatory Information for VERZENIO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eli Lilly And Co VERZENIO abemaciclib TABLET;ORAL 208716-001 Sep 28, 2017 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Eli Lilly And Co VERZENIO abemaciclib TABLET;ORAL 208716-001 Sep 28, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Eli Lilly And Co VERZENIO abemaciclib TABLET;ORAL 208716-004 Sep 28, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Eli Lilly And Co VERZENIO abemaciclib TABLET;ORAL 208716-004 Sep 28, 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

Supplementary Protection Certificates for VERZENIO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2379528 2019009 Norway   Start Trial PRODUCT NAME: ABEMACIKLIB ELLER FARMASOEYTISK AKSEPTABLE SALTER DERAV; REG. NO/DATE: EU/1/18/1307 20180927
2379528 19C1008 France   Start Trial PRODUCT NAME: ABEMACICLIB; REGISTRATION NO/DATE: EU/1/18/1307 20181001
2379528 LUC00106 Luxembourg   Start Trial PRODUCT NAME: ABEMACICLIB ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (VERZENIOS); AUTHORISATION NUMBER AND DATE: EU/1/18/1307 20181001
2379528 PA2019004,C2379528 Lithuania   Start Trial PRODUCT NAME: ABEMACIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1307 20180927
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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