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 |
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 |
---|---|
Breast Cancer Research Foundation | Phase 2 |
Praful Ravi | Phase 1/Phase 2 |
Bayer | Phase 1/Phase 2 |
Pharmacology for VERZENIO
Drug Class | Kinase Inhibitor |
Mechanism of Action | Kinase 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 ⤷ Subscribe.
This potential generic entry date is based on patent ⤷ Subscribe.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | ⤷ Subscribe | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Eli Lilly And Co | VERZENIO | abemaciclib | TABLET;ORAL | 208716-004 | Sep 28, 2017 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Eli Lilly And Co | VERZENIO | abemaciclib | TABLET;ORAL | 208716-002 | Sep 28, 2017 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
>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: ⤷ Subscribe
Australia
Patent: 09330365
Patent: Protein kinase inhibitors
Estimated Expiration: ⤷ Subscribe
Brazil
Patent: 0924183
Patent: inibidores de proteína quinase, formas cristalinas, formulações farmacêuticas e uso
Estimated Expiration: ⤷ Subscribe
Canada
Patent: 47055
Patent: INHIBITEURS DE PROTEINE KINASES (PROTEIN KINASE INHIBITORS)
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
China
Patent: 2264725
Estimated Expiration: ⤷ Subscribe
Colombia
Patent: 82125
Patent: INHIBIDORES DE PROTEÍNA QUINASA
Estimated Expiration: ⤷ Subscribe
Costa Rica
Patent: 110343
Patent: INHIBIDORES DE PROTEÍNA CINASA
Estimated Expiration: ⤷ Subscribe
Croatia
Patent: 0131051
Estimated Expiration: ⤷ Subscribe
Cyprus
Patent: 14841
Estimated Expiration: ⤷ Subscribe
Denmark
Patent: 79528
Estimated Expiration: ⤷ Subscribe
Dominican Republic
Patent: 011000204
Patent: INHIBIDORES DE PROTEINA CINASA
Estimated Expiration: ⤷ Subscribe
Ecuador
Patent: 11011157
Patent: INHIBIDORES DE PROTEÍNA CINASA
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent: 1170872
Patent: ИНГИБИТОРЫ ПРОТЕИНКИНАЗЫ
Estimated Expiration: ⤷ Subscribe
European Patent Office
Patent: 79528
Patent: INHIBITEURS DE PROTÉINE KINASES (PROTEIN KINASE INHIBITORS)
Estimated Expiration: ⤷ Subscribe
Finland
Patent: 0190008
Estimated Expiration: ⤷ Subscribe
Guatemala
Patent: 1100181
Estimated Expiration: ⤷ Subscribe
Honduras
Patent: 11001701
Patent: INHIBIDORES DE PROTEINA CINASA
Estimated Expiration: ⤷ Subscribe
Hong Kong
Patent: 59630
Patent: PROTEIN KINASE INHIBITORS
Estimated Expiration: ⤷ Subscribe
Hungary
Patent: 00509
Estimated Expiration: ⤷ Subscribe
Patent: 900014
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Japan
Patent: 17453
Estimated Expiration: ⤷ Subscribe
Patent: 12513396
Estimated Expiration: ⤷ Subscribe
Jordan
Patent: 85
Patent: مثبطات بروتين كيناز (PROTEIN KINASE INHIBITORS)
Estimated Expiration: ⤷ Subscribe
Lithuania
Patent: 379528
Estimated Expiration: ⤷ Subscribe
Patent: 2019004
Estimated Expiration: ⤷ Subscribe
Luxembourg
Patent: 0106
Estimated Expiration: ⤷ Subscribe
Malaysia
Patent: 0547
Patent: PROTEIN KINASE INHIBITORS
Estimated Expiration: ⤷ Subscribe
Mexico
Patent: 11006757
Patent: INHIBIDORES DE PROTEINA CINASA. (PROTEIN KINASE INHIBITORS.)
Estimated Expiration: ⤷ Subscribe
Morocco
Patent: 903
Patent: مثبطات البروتين كيناز
Estimated Expiration: ⤷ Subscribe
Netherlands
Patent: 0969
Estimated Expiration: ⤷ Subscribe
New Zealand
Patent: 3114
Patent: Compounds comprising benzimidazolyl, pyrimidinyl, and pyridinyl moieties which are useful as protein kinase inhibitors
Estimated Expiration: ⤷ Subscribe
Norway
Patent: 19009
Estimated Expiration: ⤷ Subscribe
Panama
Patent: 52901
Patent: INHIBIDORES DE PROTEINA CINASA
Estimated Expiration: ⤷ Subscribe
Peru
Patent: 120107
Patent: INHIBIDORES DE PROTEINA CINASA
Estimated Expiration: ⤷ Subscribe
Poland
Patent: 79528
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 79528
Estimated Expiration: ⤷ Subscribe
Serbia
Patent: 061
Patent: INHIBITORI PROTEIN KINAZE (PROTEIN KINASE INHIBITORS)
Estimated Expiration: ⤷ Subscribe
Singapore
Patent: 2331
Patent: PROTEIN KINASE INHIBITORS
Estimated Expiration: ⤷ Subscribe
Slovenia
Patent: 79528
Estimated Expiration: ⤷ Subscribe
South Africa
Patent: 1104505
Patent: PROTEIN KINASE INHIBITORS
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 1297497
Estimated Expiration: ⤷ Subscribe
Patent: 110091551
Patent: PROTEIN KINASE INHIBITORS
Estimated Expiration: ⤷ Subscribe
Spain
Patent: 35798
Estimated Expiration: ⤷ Subscribe
Taiwan
Patent: 29635
Estimated Expiration: ⤷ Subscribe
Patent: 1031653
Patent: Protein kinase inhibitors
Estimated Expiration: ⤷ Subscribe
Tunisia
Patent: 11000293
Patent: PROTEIN KINASE INHIBITORS
Estimated Expiration: ⤷ Subscribe
Ukraine
Patent: 4603
Patent: ІНГІБІТОРИ ПРОТЕЇНКІНАЗ[ИНГИБИТОРЫ ПРОТЕИНКИНАЗ (PROTEIN KINASE INHIBITORS)
Estimated Expiration: ⤷ Subscribe
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 |
---|---|---|---|
Costa Rica | 20110343 | INHIBIDORES DE PROTEÍNA CINASA | ⤷ Subscribe |
Ecuador | SP11011157 | INHIBIDORES DE PROTEÍNA CINASA | ⤷ Subscribe |
Japan | 5417453 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VERZENIO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2379528 | CA 2019 00008 | Denmark | ⤷ Subscribe | PRODUCT NAME: ABEMACICLIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1307 20181001 |
2379528 | 1990013-3 | Sweden | ⤷ Subscribe | PRODUCT NAME: ABEMACICLIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1307 20181001 |
2379528 | 132019000000037 | Italy | ⤷ Subscribe | 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 |
VERZENIO Market Analysis and Financial Projection Experimental
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