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Last Updated: March 29, 2020

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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. 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
International Patents:48
US Patents:1
Applicants:1
NDAs:1
Bulk Api Vendors: 61
Clinical Trials: 13
Patent Applications: 34
Drug Prices: Drug price information for VERZENIO
DailyMed Link:VERZENIO at DailyMed
Drug patent expirations by year for VERZENIO
Drug Prices for VERZENIO

See drug prices for VERZENIO

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
Eli Lilly and CompanyEarly Phase 1
Jose CarrilloEarly Phase 1
National Cancer Institute (NCI)Phase 1/Phase 2

See all VERZENIO clinical trials

Synonyms for VERZENIO
[5-(4-ethyl-piperazin-1-ylmethyl)-pyridin-2-yl]-[5-fluoro-4-(7-fluoro-3-isopropyl-2-methyl-3H-benzoimidazol-5-yl)-pyrimidin-2-yl]-amine
1231929-97-7
2-Pyrimidinamine, N-(5-((4-ethyl-1-piperazinyl)methyl)-2-pyridinyl)-5-fluoro-4-(4-fluoro-2-methyl-1-(1-methylethyl)-1H-benzimidazol-6-yl)
2-Pyrimidinamine, N-[5-[(4-ethyl-1-piperazinyl)methyl]-2-pyridinyl]-5-fluoro-4-[4-fluoro-2-methyl-1-(1-methylethyl)-1H-benzimidazol-6-yl]-
2-Pyrimidinamine,N-[5-[(4-ethyl-1-piperazinyl)methyl]-2-pyridinyl]-5-fluoro-4-[4-fluoro-2-methyl-1-(1-methylethyl)-1H-benzimidazol-6-yl]-
3798AH
60UAB198HK
6ZV
A12989
Abemaciclib
Abemaciclib (JAN/USAN)
Abemaciclib (ly2835219)
Abemaciclib [USAN:INN]
Abemaciclib,LY2835219
AK174895
AKOS025404907
AS-10230
AX8323622
BCP13079
BDBM50110183
bemaciclib
C27H32F2N8
CDK4/6 dual inhibitor
CHEMBL3301610
CS-1230
D10688
DA-33422
DB12001
DTXSID20673119
EX-A1588
EX-A521
FT-0700134
GTPL7382
HY-16297A
J-690083
KS-00000T51
LY 2835219
LY-2835219
LY-2835219|||N-[5-[(4-Ethylpiperazin-1-yl)methyl]pyridin-2-yl]-5-fluoro-4-(7-fluoro-2-methyl-3-propan-2-ylbenzimidazol-5-yl)pyrimidin-2-amine
LY2835219
LY2835219 (free base)
LY2835219 free base
LY2835219 free base (Abemaciclib)
LY2835219 Ms salt, Abemaciclib Ms salt
N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine
N-[5-[(4-ethylpiperazin-1-yl)methyl]pyridin-2-yl]-5-fluoro-4-(7-fluoro-2-methyl-3-propan-2-ylbenzimidazol-5-yl)pyrimidin-2-amine
N-{5-[(4-ethylpiperazin-1-yl)methyl]pyridin-2-yl}-5-fluoro-4-(7-fluoro-3-isopropyl-2-methyl-1,3-benzodiazol-5-yl)pyrimidin-2-amine
N-{5-[(4-Ethylpiperazin-1-yl)methyl]pyridin-2-yl}-5-fluoro-4-[4-fluoro-2-methyl-1-(propan-2-yl)-1H-benzimidazol-6-yl]pyrimidin-2-amine
NCGC00351599-06
Q23901483
QC-11713
s5716
SB16476
SC-82423
SCHEMBL2487229
Tube014
UNII-60UAB198HK
UZWDCWONPYILKI-UHFFFAOYSA-N
Verzenio (TN)
Verzenios
W-5974
ZINC000072318121
ZINC72318121

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
Eli Lilly And Co VERZENIO abemaciclib TABLET;ORAL 208716-003 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 208716-002 Sep 28, 2017 RX Yes No   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 132019000000037 Italy   Start Trial PRODUCT NAME: ABEMACICLIB(VERZENIOS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1307, 20181001
2379528 C201930017 Spain   Start Trial PRODUCT NAME: ABEMACICLIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1307; DATE OF AUTHORISATION: 20180927; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1307; DATE OF FIRST AUTHORISATION IN EEA: 20180927
2379528 C20190008 00271 Estonia   Start Trial PRODUCT NAME: ABEMATSIKLIIB;REG NO/DATE: EU/1/18/1307 01.10.2018
2379528 300969 Netherlands   Start Trial PRODUCT NAME: ABEMACICLIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/18/1307 20181001
2379528 19C1008 France   Start Trial PRODUCT NAME: ABEMACICLIB; REGISTRATION NO/DATE: EU/1/18/1307 20181001
2379528 CA 2019 00008 Denmark   Start Trial PRODUCT NAME: ABEMACICLIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1307 20181001
2379528 2019009 Norway   Start Trial PRODUCT NAME: ABEMACIKLIB ELLER FARMASOEYTISK AKSEPTABLE SALTER DERAV; REG. NO/DATE: EU/1/18/1307 20180927
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Moodys
Merck
Dow
Boehringer Ingelheim
Johnson and Johnson

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 verification 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.