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Last Updated: April 17, 2024

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-one patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for abemaciclib
International Patents:51
US Patents:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 83
Clinical Trials: 171
Patent Applications: 1,930
What excipients (inactive ingredients) are in abemaciclib?abemaciclib excipients list
DailyMed Link:abemaciclib at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for abemaciclib
Generic Entry Date for abemaciclib*:
Constraining patent/regulatory exclusivity:

*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 abemaciclib

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

Universitaire Ziekenhuizen KU LeuvenPhase 2
Kom Op Tegen KankerPhase 2
University of MiamiPhase 2

See all abemaciclib clinical trials

Pharmacology for abemaciclib
Drug ClassKinase Inhibitor
Mechanism of ActionKinase 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 208716-001 Sep 28, 2017 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  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
>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

International Patents for abemaciclib

Country Patent Number Title Estimated Expiration
Hungary S000509 ⤷  Try a Trial
Israel 213350 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) ⤷  Try a Trial
Brazil PI0924183 inibidores de proteína quinase, formas cristalinas, formulações farmacêuticas e uso ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for abemaciclib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2379528 122019000010 Germany ⤷  Try a Trial PRODUCT NAME: ABEMACICLIB; REGISTRATION NO/DATE: EU/1/18/1307 20180927
2379528 C20190008 00271 Estonia ⤷  Try a Trial PRODUCT NAME: ABEMATSIKLIIB;REG NO/DATE: EU/1/18/1307 01.10.2018
2379528 19C1008 France ⤷  Try a Trial PRODUCT NAME: ABEMACICLIB; REGISTRATION NO/DATE: 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.