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Last Updated: May 19, 2022

VERZENIO Drug Patent 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 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

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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
Drug patent expirations by year for VERZENIO
Drug Prices for VERZENIO

See drug prices for VERZENIO

DrugPatentWatch® Estimated 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
University of California, San FranciscoPhase 1/Phase 2
Prostate Cancer FoundationPhase 1/Phase 2
Veru Inc.Phase 2

See all VERZENIO clinical trials

Pharmacology for VERZENIO
Drug ClassKinase Inhibitor
Mechanism of Action Kinase Inhibitors

US Patents and Regulatory Information for VERZENIO

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VERZENIO is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: IN COMBINATION WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE-BASED THERAPY FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER

Protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: IN COMBINATION WITH FULVESTRANT FOR THE TREATMENT OF WOMEN WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER WITH DISEASE PROGRESSION FOLLOWING ENDOCRINE THERAPY

Protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: AS MONOTHERAPY FOR THE TREATMENT OF ADULT PATIENTS WITH HR-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTIC BREAST CANCER WITH DISEASE PROGRESSION FOLLOWING ENDOCRINE THERAPY AND PRIOR CHEMOTHERAPY IN THE METASTATIC SETTING

Protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: IN COMBINATION WITH ENDOCRINE THERAPY (TAMOXIFEN OR AN AROMATASE INHIBITOR) FOR THE ADJUVANT TREATMENT OF ADULT PATIENTS WITH HR-POSITIVE, HER2-NEGATIVE, NODE-POSITIVE, EARLY BREAST CANCER AT HIGH RISK OF RECURRENCE AND A KI-67 SCORE >=20%

Protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: IN COMBINATION WITH FULVESTRANT FOR THE TREATMENT OF ADULT PATIENTS WITH HR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER WITH DISEASE PROGRESSION FOLLOWING ENDROCRINE THERAPY

Protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: IN COMBINATION WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE-BASED THERAPY FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN, AND MEN WITH HR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER

Protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: IN COMBINATION WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE-BASED THERAPY FOR TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER-2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER

FDA Regulatory Exclusivity protecting VERZENIO

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

INDICATION FOR THE USE OF ABEMACICLIB IN COMBINATION WITH ENDOCRINE THERAPY (TAMOXIFEN OR AN AROMATASE INHIBITOR) FOR THE ADJUVANT TREATMENT OF ADULT PATIENTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE, NODE-POSITIVE, EARLY CANCER (EBC) AT HIGH RISK OF RECURRENCE AND A KI-67 SCORE>20% AS DETERMINED BY AN FDA APPROVED TEST
Exclusivity Expiration: See Plans and Pricing

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

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

Patent: 4575
Estimated Expiration: See Plans and Pricing

Australia

Patent: 09330365
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0924183
Estimated Expiration: See Plans and Pricing

Canada

Patent: 47055
Estimated Expiration: See Plans and Pricing

Chile

Patent: 11001527
Estimated Expiration: See Plans and Pricing

China

Patent: 2264725
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 82125
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 110343
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0131051
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 14841
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 79528
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 011000204
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 11011157
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 8808
Estimated Expiration: See Plans and Pricing

Patent: 1170872
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 79528
Estimated Expiration: See Plans and Pricing

Guatemala

Patent: 1100181
Estimated Expiration: See Plans and Pricing

Honduras

Patent: 11001701
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 59630
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 00509
Estimated Expiration: See Plans and Pricing

Patent: 900014
Estimated Expiration: See Plans and Pricing

Israel

Patent: 3350
Estimated Expiration: See Plans and Pricing

Japan

Patent: 17453
Estimated Expiration: See Plans and Pricing

Patent: 12513396
Estimated Expiration: See Plans and Pricing

Jordan

Patent: 85
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 379528
Estimated Expiration: See Plans and Pricing

Patent: 2019004
Estimated Expiration: See Plans and Pricing

Luxembourg

Patent: 0106
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 0547
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 11006757
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 903
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 0969
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 3114
Estimated Expiration: See Plans and Pricing

Norway

Patent: 19009
Estimated Expiration: See Plans and Pricing

Panama

Patent: 52901
Estimated Expiration: See Plans and Pricing

Peru

Patent: 120107
Estimated Expiration: See Plans and Pricing

Poland

Patent: 79528
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 79528
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 061
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 2331
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 79528
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1104505
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1297497
Estimated Expiration: See Plans and Pricing

Patent: 110091551
Estimated Expiration: See Plans and Pricing

Spain

Patent: 35798
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 29635
Estimated Expiration: See Plans and Pricing

Patent: 1031653
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 11000293
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 4603
Estimated Expiration: See Plans and Pricing

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 See Plans and Pricing
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) See Plans and Pricing
Cyprus 1114841 See Plans and Pricing
Malaysia 150547 PROTEIN KINASE INHIBITORS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VERZENIO

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

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Serving leading biopharmaceutical companies globally:

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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.