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Last Updated: October 4, 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 September 28, 2031. 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: 42
Patent Applications: 580
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
Breast Cancer Research FoundationPhase 2
Praful RaviPhase 1/Phase 2
BayerPhase 1/Phase 2

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 five US patents and two FDA Regulatory Exclusivities.

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

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up

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: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Eli Lilly And Co VERZENIO abemaciclib TABLET;ORAL 208716-004 Sep 28, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eli Lilly And Co VERZENIO abemaciclib TABLET;ORAL 208716-002 Sep 28, 2017 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
>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
Patent: COMPUESTO DE BENZOIMIDAZOL-PIRIMIDIN-AMINOPIRIDINA, FORMA CRISTALINA III RELACIONADA, FORMULACION FARMACEUTICA QUE LO COMPRENDE Y SU USO PARA PREPARAR UN MEDICAMENTO UTIL PARA TRATAR UN CANCER
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 09330365
Patent: Protein kinase inhibitors
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0924183
Patent: inibidores de proteína quinase, formas cristalinas, formulações farmacêuticas e uso
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 47055
Patent: INHIBITEURS DE PROTEINE KINASES (PROTEIN KINASE INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 11001527
Patent: Compuestos derivados de n-(piridin-2-il)-4-(2-metil-1h-benzo[d]imidazol-6-il)-pirimidin-2-amina; forma cristalina iii de [5-(4-etil-piperazin-1-ilmetil)-piridin-2-il]-[5-fluoro-4-(7-fluoro-3-isoptopil-2-metil-3h-benzoimidazol-5-il)-pirimidin-2-il] amina; composicion farmaceutica; y su uso para el tratamiento de cancer.
Estimated Expiration: ⤷  Sign Up

China

Patent: 2264725
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 82125
Patent: INHIBIDORES DE PROTEÍNA QUINASA
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 110343
Patent: INHIBIDORES DE PROTEÍNA CINASA
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0131051
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 14841
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 79528
Estimated Expiration: ⤷  Sign Up

Dominican Republic

Patent: 011000204
Patent: INHIBIDORES DE PROTEINA CINASA
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 11011157
Patent: INHIBIDORES DE PROTEÍNA CINASA
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 8808
Patent: ИНГИБИТОРЫ ПРОТЕИНКИНАЗЫ, ФАРМАЦЕВТИЧЕСКИЙ СОСТАВ НА ИХ ОСНОВЕ И ПРИМЕНЕНИЕ В ТЕРАПИИ (PROTEIN KINASE INHIBITORS, PHARMACEUTICAL COMPOSITION BASED THEREON AND THERAPEUTICAL USE)
Estimated Expiration: ⤷  Sign Up

Patent: 1170872
Patent: ИНГИБИТОРЫ ПРОТЕИНКИНАЗЫ
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 79528
Patent: INHIBITEURS DE PROTÉINE KINASES (PROTEIN KINASE INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Finland

Patent: 0190008
Estimated Expiration: ⤷  Sign Up

Guatemala

Patent: 1100181
Estimated Expiration: ⤷  Sign Up

Honduras

Patent: 11001701
Patent: INHIBIDORES DE PROTEINA CINASA
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 59630
Patent: PROTEIN KINASE INHIBITORS
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 00509
Estimated Expiration: ⤷  Sign Up

Patent: 900014
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 3350
Patent: מעכבי פרוטאין קינאז, תכשירים רוקחיים המכילים אותם ושימושם להכנת תרופות לטיפול בסרטן (Protein kinase inhibitor compounds, pharmaceutical compositions comprising them and their use in the preparation of medicaments for the treatment of cancer)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 17453
Estimated Expiration: ⤷  Sign Up

Patent: 12513396
Estimated Expiration: ⤷  Sign Up

Jordan

Patent: 85
Patent: مثبطات بروتين كيناز (PROTEIN KINASE INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 379528
Estimated Expiration: ⤷  Sign Up

Patent: 2019004
Estimated Expiration: ⤷  Sign Up

Luxembourg

Patent: 0106
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 0547
Patent: PROTEIN KINASE INHIBITORS
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 11006757
Patent: INHIBIDORES DE PROTEINA CINASA. (PROTEIN KINASE INHIBITORS.)
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 903
Patent: مثبطات البروتين كيناز
Estimated Expiration: ⤷  Sign Up

Netherlands

Patent: 0969
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 3114
Patent: Compounds comprising benzimidazolyl, pyrimidinyl, and pyridinyl moieties which are useful as protein kinase inhibitors
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 19009
Estimated Expiration: ⤷  Sign Up

Panama

Patent: 52901
Patent: INHIBIDORES DE PROTEINA CINASA
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 120107
Patent: INHIBIDORES DE PROTEINA CINASA
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 79528
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 79528
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 061
Patent: INHIBITORI PROTEIN KINAZE (PROTEIN KINASE INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 2331
Patent: PROTEIN KINASE INHIBITORS
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 79528
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1104505
Patent: PROTEIN KINASE INHIBITORS
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1297497
Estimated Expiration: ⤷  Sign Up

Patent: 110091551
Patent: PROTEIN KINASE INHIBITORS
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 35798
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 29635
Estimated Expiration: ⤷  Sign Up

Patent: 1031653
Patent: Protein kinase inhibitors
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 11000293
Patent: PROTEIN KINASE INHIBITORS
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 4603
Patent: ІНГІБІТОРИ ПРОТЕЇНКІНАЗ[ИНГИБИТОРЫ ПРОТЕИНКИНАЗ (PROTEIN KINASE INHIBITORS)
Estimated Expiration: ⤷  Sign Up

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
Norway 2019009 ⤷  Sign Up
Guatemala 201100181 "INHIBIDORES DE PROTEINA CINASA" ⤷  Sign Up
Japan 5417453 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VERZENIO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2379528 LUC00106 Luxembourg ⤷  Sign Up PRODUCT NAME: ABEMACICLIB ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (VERZENIOS); AUTHORISATION NUMBER AND DATE: EU/1/18/1307 20181001
2379528 PA2019004 Lithuania ⤷  Sign Up PRODUCT NAME: ABEMACIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1307 20180927
2379528 C20190008 00271 Estonia ⤷  Sign Up PRODUCT NAME: ABEMATSIKLIIB;REG NO/DATE: EU/1/18/1307 01.10.2018
>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.