Details for New Drug Application (NDA): 208716
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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 Action | Kinase 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: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Sep 28, 2017 | TE: | 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 Up | Patent Expiration: | Sep 28, 2031 | Product Flag? | Y | Substance Flag? | Y | Delist 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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