Abemaciclib - Generic Drug Details

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What are the generic 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
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	184
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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 abemaciclib

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

Sponsor	Phase
Breast Cancer Research Foundation	Phase 2
Mridula George, MD	Phase 1
University of Illinois at Chicago	Phase 4

See all abemaciclib clinical trials

Pharmacology for abemaciclib

Drug Class	Kinase Inhibitor
Mechanism of Action	Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for abemaciclib

L01EF	Cyclin-dependent kinase (CDK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for abemaciclib

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Glossary

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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	208716-002	Sep 28, 2017		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-003	Sep 28, 2017		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-003	Sep 28, 2017		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-004	Sep 28, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-004	Sep 28, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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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

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Country	Patent Number	Title	Estimated Expiration
New Zealand	593114	Compounds comprising benzimidazolyl, pyrimidinyl, and pyridinyl moieties which are useful as protein kinase inhibitors	⤷ Sign Up
Luxembourg	C00106		⤷ Sign Up
Panama	8852901	INHIBIDORES DE PROTEINA CINASA	⤷ Sign Up
Hungary	S1900014		⤷ Sign Up
Hungary	S000509		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for abemaciclib

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2379528	C201930017	Spain	⤷ Sign Up	PRODUCT NAME: ABEMACICLIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1307; DATE OF AUTHORISATION: 20180927; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1307; DATE OF FIRST AUTHORISATION IN EEA: 20180927
2379528	9/2019	Austria	⤷ Sign Up	PRODUCT NAME: ABEMACICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1307 (MITTEILUNG) 20181001
2379528	SPC/GB19/012	United Kingdom	⤷ Sign Up	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	122019000010	Germany	⤷ Sign Up	PRODUCT NAME: ABEMACICLIB; REGISTRATION NO/DATE: EU/1/18/1307 20180927
2379528	C02379528/01	Switzerland	⤷ Sign Up	PRODUCT NAME: ABEMACICLIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66833 21.05.2019
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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