DrugPatentWatch Database Preview

VERZENIO Drug Profile

Email this page to a colleague

« Back to Dashboard

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

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

See drug prices for VERZENIO

Generic Entry Opportunity Date for VERZENIO

NDA:

208716

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

Sponsor	Phase
Eli Lilly and Company	Early Phase 1
Jose Carrillo	Early 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			Y	Y
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-001	Sep 28, 2017		RX	Yes	No
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-004	Sep 28, 2017		RX	Yes	Yes
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-004	Sep 28, 2017		RX	Yes	Yes			Y	Y
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-003	Sep 28, 2017		RX	Yes	No
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-004	Sep 28, 2017		RX	Yes	Yes
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-002	Sep 28, 2017		RX	Yes	No			Y	Y

International Patents for VERZENIO

Country	Patent Number	Estimated Expiration
Denmark	2379528
South Korea	20110091551
European Patent Office	2379528
Israel	213350
Colombia	6382125
Tunisia	2011000293
Malaysia	150547

Supplementary Protection Certificates for VERZENIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2379528	132019000000037	Italy		PRODUCT NAME: ABEMACICLIB(VERZENIOS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1307, 20181001
2379528	C201930017	Spain		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		PRODUCT NAME: ABEMATSIKLIIB;REG NO/DATE: EU/1/18/1307 01.10.2018
2379528	300969	Netherlands		PRODUCT NAME: ABEMACICLIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/18/1307 20181001
2379528	19C1008	France		PRODUCT NAME: ABEMACICLIB; REGISTRATION NO/DATE: EU/1/18/1307 20181001
2379528	CA 2019 00008	Denmark		PRODUCT NAME: ABEMACICLIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1307 20181001
2379528	2019009	Norway		PRODUCT NAME: ABEMACIKLIB ELLER FARMASOEYTISK AKSEPTABLE SALTER DERAV; REG. NO/DATE: EU/1/18/1307 20180927