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Last Updated: March 29, 2024

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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-one patent family members in forty-five 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:51
US Patents:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 83
Clinical Trials: 41
Patent Applications: 804
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 Loss of Exclusivity (LOE) 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
Praful RaviPhase 1/Phase 2
BayerPhase 1/Phase 2
Relay Therapeutics, 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

VERZENIO is protected by nine US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VERZENIO is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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

Protein kinase inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: IN COMBINATION WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE-BASED THERAPY FOR THE TREATMENT OF ADULT PATIENTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER

Protein kinase inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 ENDOCRINE THERAPY

Protein kinase inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 PATIENT POPULATION
Exclusivity Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial

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 208716-003 Sep 28, 2017 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eli Lilly And Co VERZENIO abemaciclib TABLET;ORAL 208716-001 Sep 28, 2017 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Eli Lilly And Co VERZENIO abemaciclib TABLET;ORAL 208716-002 Sep 28, 2017 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eli Lilly And Co VERZENIO abemaciclib TABLET;ORAL 208716-003 Sep 28, 2017 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Eli Lilly And Co VERZENIO abemaciclib TABLET;ORAL 208716-004 Sep 28, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for VERZENIO

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Eli Lilly Nederland B.V. Verzenios abemaciclib EMEA/H/C/004302
Early Breast CancerVerzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, node positive early breast cancer at high risk of recurrence (see section 5.1).In pre or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.Advanced or Metastatic Breast CancerVerzenios is indicated for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist.
Authorised no no no 2018-09-26
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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: ⤷  Try a Trial

Australia

Patent: 09330365
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0924183
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 47055
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 11001527
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2264725
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 82125
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 110343
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0131051
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 14841
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 79528
Estimated Expiration: ⤷  Try a Trial

Dominican Republic

Patent: 011000204
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 11011157
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 8808
Estimated Expiration: ⤷  Try a Trial

Patent: 1170872
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 79528
Estimated Expiration: ⤷  Try a Trial

Finland

Patent: 0190008
Estimated Expiration: ⤷  Try a Trial

Guatemala

Patent: 1100181
Estimated Expiration: ⤷  Try a Trial

Honduras

Patent: 11001701
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 59630
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 00509
Estimated Expiration: ⤷  Try a Trial

Patent: 900014
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 3350
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 17453
Estimated Expiration: ⤷  Try a Trial

Patent: 12513396
Estimated Expiration: ⤷  Try a Trial

Jordan

Patent: 85
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 379528
Estimated Expiration: ⤷  Try a Trial

Patent: 2019004
Estimated Expiration: ⤷  Try a Trial

Luxembourg

Patent: 0106
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 0547
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 11006757
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 903
Estimated Expiration: ⤷  Try a Trial

Netherlands

Patent: 0969
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 3114
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 19009
Estimated Expiration: ⤷  Try a Trial

Panama

Patent: 52901
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 120107
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 79528
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 79528
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 061
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 2331
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 79528
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1104505
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1297497
Estimated Expiration: ⤷  Try a Trial

Patent: 110091551
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 35798
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 29635
Estimated Expiration: ⤷  Try a Trial

Patent: 1031653
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 11000293
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 4603
Estimated Expiration: ⤷  Try a Trial

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
Cyprus 1114841 ⤷  Try a Trial
Japan 5417453 ⤷  Try a Trial
Ecuador SP11011157 INHIBIDORES DE PROTEÍNA CINASA ⤷  Try a Trial
Croatia P20131051 ⤷  Try a Trial
Portugal 2379528 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VERZENIO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2379528 132019000000037 Italy ⤷  Try a Trial PRODUCT NAME: ABEMACICLIB(VERZENIOS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1307, 20181001
2379528 C201930017 Spain ⤷  Try a 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 ⤷  Try a Trial PRODUCT NAME: ABEMATSIKLIIB;REG NO/DATE: EU/1/18/1307 01.10.2018
2379528 300969 Netherlands ⤷  Try a Trial PRODUCT NAME: ABEMACICLIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/18/1307 20181001
2379528 2019/015 Ireland ⤷  Try a Trial PRODUCT NAME: ABEMACICLIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/18/1307 20180927
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.