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
Summary for VERZENIO
| International Patents: | 51 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 82 |
| 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 |
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
| Sponsor | Phase |
|---|---|
| Praful Ravi | Phase 1/Phase 2 |
| Bayer | Phase 1/Phase 2 |
| Relay Therapeutics, Inc. | Phase 1 |
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 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 | ||||
| Eli Lilly And Co | VERZENIO | abemaciclib | TABLET;ORAL | 208716-004 | Sep 28, 2017 | RX | Yes | Yes | ⤷ 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 | Y | Y | ⤷ 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 |
|---|---|---|---|
| South Korea | 20110091551 | PROTEIN KINASE INHIBITORS | ⤷ Try a Trial |
| Denmark | 2379528 | ⤷ Try a Trial | |
| Costa Rica | 20110343 | INHIBIDORES DE PROTEÍNA CINASA | ⤷ Try a Trial |
| Lithuania | C2379528 | ⤷ Try a Trial | |
| Japan | 2012513396 | ⤷ Try a Trial | |
| Spain | 2435798 | ⤷ Try a Trial | |
| Finland | C20190008 | ⤷ 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 | 2019/015 | Ireland | ⤷ Try a Trial | PRODUCT NAME: ABEMACICLIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/18/1307 20180927 |
| 2379528 | 1990013-3 | Sweden | ⤷ Try a Trial | PRODUCT NAME: ABEMACICLIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1307 20181001 |
| 2379528 | 2019C/507 | Belgium | ⤷ Try a Trial | PRODUCT NAME: VERZENIOS - ABEMACICLIB; AUTHORISATION NUMBER AND DATE: EU/1/18/1307 20181001 |
| 2379528 | 122019000010 | Germany | ⤷ Try a Trial | PRODUCT NAME: ABEMACICLIB; REGISTRATION NO/DATE: EU/1/18/1307 20180927 |
| 2379528 | 19C1008 | France | ⤷ Try a Trial | PRODUCT NAME: ABEMACICLIB; REGISTRATION NO/DATE: EU/1/18/1307 20181001 |
| 2379528 | SPC/GB19/012 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ABEMACICLIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/18/1307 20181001; UK PLGB14895/0263 20181001; UK PLGB14895/0264 20181001; UK PLGB14895/0265 20181001 |
| 2379528 | 132019000000037 | Italy | ⤷ Try a Trial | PRODUCT NAME: ABEMACICLIB(VERZENIOS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1307, 20181001 |
| >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.
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