VERZENIO Drug Patent Profile

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 fifty patent family members in forty-four countries.

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

DrugPatentWatch^® Generic Entry Outlook for Verzenio

Verzenio was eligible for patent challenges on September 28, 2021.

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:	50
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	33
Patent Applications:	658
Drug Prices:	Drug price information for VERZENIO
What excipients (inactive ingredients) are in VERZENIO?	VERZENIO excipients list
DailyMed Link:	VERZENIO at DailyMed

See drug prices for VERZENIO

DrugPatentWatch^® Estimated 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
University of California, San Francisco	Phase 1/Phase 2
Prostate Cancer Foundation	Phase 1/Phase 2
Veru Inc.	Phase 2

See all VERZENIO clinical trials

Pharmacology for VERZENIO

Drug Class	Kinase Inhibitor
Mechanism of Action	Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for VERZENIO

L01EF	Cyclin-dependent kinase (CDK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for VERZENIO

VERZENIO is protected by seven US patents and three FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting VERZENIO

FDA Regulatory Exclusivity protecting 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	208716-004	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	208716-004	Sep 28, 2017		RX	Yes	Yes
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-001	Sep 28, 2017		RX	Yes	No			Y	Y

International Patents for VERZENIO

When does loss-of-exclusivity occur for VERZENIO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Guatemala

Honduras

Hong Kong

Hungary

Israel

Japan

Jordan

Lithuania

Luxembourg

Malaysia

Mexico

Morocco

Netherlands

New Zealand

Norway

Panama

Peru

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VERZENIO around the world.

Country	Patent Number	Title	Estimated Expiration
Singapore	172331	PROTEIN KINASE INHIBITORS
Eurasian Patent Organization	018808	ИНГИБИТОРЫ ПРОТЕИНКИНАЗЫ, ФАРМАЦЕВТИЧЕСКИЙ СОСТАВ НА ИХ ОСНОВЕ И ПРИМЕНЕНИЕ В ТЕРАПИИ (PROTEIN KINASE INHIBITORS, PHARMACEUTICAL COMPOSITION BASED THEREON AND THERAPEUTICAL USE)
Cyprus	1114841
Malaysia	150547	PROTEIN KINASE INHIBITORS

Supplementary Protection Certificates for VERZENIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2379528	9/2019	Austria		PRODUCT NAME: ABEMACICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1307 (MITTEILUNG) 20181001
2379528	132019000000037	Italy		PRODUCT NAME: ABEMACICLIB(VERZENIOS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1307, 20181001
2379528	LUC00106	Luxembourg		PRODUCT NAME: ABEMACICLIB ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (VERZENIOS); AUTHORISATION NUMBER AND DATE: EU/1/18/1307 20181001
2379528	2019C/507	Belgium		PRODUCT NAME: VERZENIOS - ABEMACICLIB; AUTHORISATION NUMBER AND DATE: EU/1/18/1307 20181001