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
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 |


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
Sponsor | Phase |
---|---|
University of California, San Francisco | Phase 1/Phase 2 |
Prostate Cancer Foundation | Phase 1/Phase 2 |
Veru Inc. | Phase 2 |
Pharmacology for VERZENIO
Drug Class | Kinase Inhibitor |
Mechanism of Action | Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for VERZENIO
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 |