ABEMACICLIB - Generic Drug Details

What are the generic drug sources for abemaciclib and what is the scope of freedom to operate?

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:	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

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
Kom Op Tegen Kanker	Phase 2
Universitaire Ziekenhuizen KU Leuven	Phase 2
University of Miami	Phase 2

See all ABEMACICLIB clinical trials

Pharmacology for ABEMACICLIB

Drug Class	Kinase 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	208716-002	Sep 28, 2017		RX	Yes	No			Y	Y
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-002	Sep 28, 2017		RX	Yes	No
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-003	Sep 28, 2017		RX	Yes	No
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-004	Sep 28, 2017		RX	Yes	Yes			Y	Y
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-004	Sep 28, 2017		RX	Yes	Yes
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-001	Sep 28, 2017		RX	Yes	No			Y	Y

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

International Patents for ABEMACICLIB

Country	Patent Number	Title	Estimated Expiration
Japan	5417453
Hong Kong	1159630	PROTEIN KINASE INHIBITORS
Denmark	2379528
Slovenia	2379528
Eurasian Patent Organization	018808	ИНГИБИТОРЫ ПРОТЕИНКИНАЗЫ, ФАРМАЦЕВТИЧЕСКИЙ СОСТАВ НА ИХ ОСНОВЕ И ПРИМЕНЕНИЕ В ТЕРАПИИ (PROTEIN KINASE INHIBITORS, PHARMACEUTICAL COMPOSITION BASED THEREON AND THERAPEUTICAL USE)
Morocco	32903	مثبطات البروتين كيناز

Supplementary Protection Certificates for ABEMACICLIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2379528	2019/015	Ireland		PRODUCT NAME: ABEMACICLIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/18/1307 20180927
2379528	9/2019	Austria		PRODUCT NAME: ABEMACICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1307 (MITTEILUNG) 20181001
2379528	C201930017	Spain		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	PA2019004,C2379528	Lithuania		PRODUCT NAME: ABEMACIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1307 20180927
2379528	PA2019004	Lithuania		PRODUCT NAME: ABEMACIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1307 20180927
2379528	122019000010	Germany		PRODUCT NAME: ABEMACICLIB; REGISTRATION NO/DATE: EU/1/18/1307 20180927