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Generated: November 14, 2018

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Details for New Drug Application (NDA): 208716

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NDA 208716 describes VERZENIO, which is a drug marketed by Eli Lilly And Co and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the VERZENIO profile page.

The generic ingredient in VERZENIO is abemaciclib. One supplier is listed for this compound. Additional details are available on the abemaciclib profile page.
Summary for 208716
Tradename:VERZENIO
Applicant:Eli Lilly And Co
Ingredient:abemaciclib
Patents:1
Generic Entry Opportunity Date for 208716
Generic Entry Date for 208716*:
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.

Pharmacology for NDA: 208716
Mechanism of ActionKinase Inhibitors
Suppliers and Packaging for NDA: 208716
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VERZENIO abemaciclib TABLET;ORAL 208716 NDA Eli Lilly and Company 0002-4483 0002-4483-54 1 BLISTER PACK in 1 CARTON (0002-4483-54) > 14 TABLET in 1 BLISTER PACK
VERZENIO abemaciclib TABLET;ORAL 208716 NDA Eli Lilly and Company 0002-4815 0002-4815-54 1 BLISTER PACK in 1 CARTON (0002-4815-54) > 14 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Sep 28, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 26, 2021
Regulatory Exclusivity Use:IN COMBINATION WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE-BASED THERAPY FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER
Regulatory Exclusivity Expiration:Sep 28, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Sign UpPatent Expiration:Dec 15, 2029Product Flag?YSubstance Flag?YDelist Request?
Patented Use:AS MONOTHERAPY FOR THE TREATMENT OF ADULT PATIENTS WITH HR-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTIC BREAST CANCER WITH DISEASE PROGRESSION FOLLOWING ENDOCRINE THERAPY AND PRIOR CHEMOTHERAPY IN THE METASTATIC SETTING

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