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Last Updated: November 22, 2024

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
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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:Oct 12, 2024
Regulatory Exclusivity Use:INDICATION FOR THE USE OF ABEMACICLIB IN COMBINATION WITH ENDOCRINE THERAPY (TAMOXIFEN OR AN AROMATASE INHIBITOR) FOR THE ADJUVANT TREATMENT OF ADULT PATIENTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE, NODE-POSITIVE, EARLY CANCER (EBC) AT HIGH RISK OF RECURRENCE AND A KI-67 SCORE>20% AS DETERMINED BY AN FDA APPROVED TEST
Regulatory Exclusivity Expiration:Oct 12, 2024
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:⤷  Sign UpPatent Expiration:Sep 28, 2031Product 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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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.