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Last Updated: January 27, 2023

Abemaciclib - Generic Drug Details


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What are the generic drug sources for abemaciclib and what is the scope of patent protection?

Abemaciclib is the generic ingredient in one branded drug marketed by Eli Lilly And Co and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Abemaciclib has fifty patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for abemaciclib
International Patents:50
US Patents:1
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 78
Clinical Trials: 158
Patent Applications: 2,332
What excipients (inactive ingredients) are in abemaciclib?abemaciclib excipients list
DailyMed Link:abemaciclib at DailyMed
Recent Clinical Trials for abemaciclib

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Praful RaviPhase 1/Phase 2
BayerPhase 1/Phase 2
Adrienne G. WaksPhase 1/Phase 2

See all abemaciclib clinical trials

Pharmacology for abemaciclib
Drug ClassKinase Inhibitor
Mechanism of Action Kinase Inhibitors

US Patents and Regulatory Information for abemaciclib

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 208716-003 Sep 28, 2017 RX Yes No 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 208716-001 Sep 28, 2017 RX Yes No See Plans and Pricing See Plans and Pricing 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

EU/EMA Drug Approvals for abemaciclib

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

Supplementary Protection Certificates for abemaciclib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2379528 PA2019004,C2379528 Lithuania See Plans and Pricing PRODUCT NAME: ABEMACIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1307 20180927
2379528 CA 2019 00008 Denmark See Plans and Pricing PRODUCT NAME: ABEMACICLIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1307 20181001
2379528 PA2019004 Lithuania See Plans and Pricing PRODUCT NAME: ABEMACIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1307 20180927
2379528 2019/015 Ireland See Plans and Pricing 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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