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.
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: | ⤷ Try a Trial | Patent Expiration: | Dec 15, 2029 | 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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