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*:
Constraining patent/regulatory exclusivity:
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 |
Pharmacology for abemaciclib
Drug Class | Kinase Inhibitor |
Mechanism of Action | Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for abemaciclib
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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Eli Lilly And Co | VERZENIO | abemaciclib | TABLET;ORAL | 208716-001 | Sep 28, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
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 | 208716-004 | Sep 28, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 | 208716-001 | 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 | ||||
>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 |
---|---|---|---|
Hong Kong | 1159630 | PROTEIN KINASE INHIBITORS | ⤷ Sign Up |
Spain | 2435798 | ⤷ Sign Up | |
Australia | 2009330365 | Protein kinase inhibitors | ⤷ Sign Up |
Cyprus | 1114841 | ⤷ Sign Up | |
Singapore | 172331 | PROTEIN KINASE INHIBITORS | ⤷ Sign Up |
Norway | 2019009 | ⤷ Sign Up | |
Tunisia | 2011000293 | PROTEIN KINASE INHIBITORS | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for abemaciclib
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2379528 | PA2019004 | Lithuania | ⤷ Sign Up | PRODUCT NAME: ABEMACIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1307 20180927 |
2379528 | LUC00106 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: ABEMACICLIB ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (VERZENIOS); AUTHORISATION NUMBER AND DATE: EU/1/18/1307 20181001 |
2379528 | 132019000000037 | Italy | ⤷ Sign Up | PRODUCT NAME: ABEMACICLIB(VERZENIOS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1307, 20181001 |
2379528 | CA 2019 00008 | Denmark | ⤷ Sign Up | PRODUCT NAME: ABEMACICLIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1307 20181001 |
2379528 | 122019000010 | Germany | ⤷ Sign Up | PRODUCT NAME: ABEMACICLIB; REGISTRATION NO/DATE: EU/1/18/1307 20180927 |
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 | PA2019004,C2379528 | Lithuania | ⤷ Sign Up | PRODUCT NAME: ABEMACIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1307 20180927 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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