Prescription medicine
Abemaciclib Brand names: Verzenio
Abemaciclib (Verzenio) is a prescription medicine with an FDA approval on record since 2017. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the abemaciclib FDA label on DailyMed (effective July 13, 2026, Eli Lilly and Company); the NDA 208716 record on Drugs@FDA; every abemaciclib label on DailyMed.
Highlights of the record
FDA label of July 13, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVERZENIO ® is a kinase inhibitor indicated: 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 breast cancer at high risk of recurrence.
Forms and strengths
- 50 mg
- 100 mg
- 150 mg
- 200 mg
Tablet.
On the market
- Earliest approval on file
- September 28, 2017 Verzenio, Eli Lilly And Co; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- September 28, 2031 Verzenio tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
What is abemaciclib used for?
From the label: indications and usageVERZENIO ® is a kinase inhibitor indicated: 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 breast cancer at high risk of recurrence. ( 1.1 , 14.1 ) in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. […]
Conditions named in the indications of abemaciclib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (Verzenio), Eli Lilly and Company, effective July 13, 2026 (SPL set be4bc0de-0fdc-4d46-8d25-be43c79e6a06), via openFDA; the full label on DailyMed
What does the patient leaflet for abemaciclib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about VERZENIO?VERZENIO may cause serious side effects including: Diarrhea. Diarrhea is common with VERZENIO treatment and may sometimes be severe. Diarrhea may cause you to develop dehydration or an infection. The most common time to develop diarrhea is during the first month of VERZENIO treatment. If you develop diarrhea during treatment with VERZENIO, your healthcare provider may tell you to temporarily stop taking VERZENIO, stop your treatment, or decrease your dose. – If you have any loose stools, start taking an antidiarrheal medicine (such as loperamide), drink more fluids, and tell your healthcare provider right away. Low white blood cell counts (neutropenia). Low white blood cell counts are common during treatment with VERZENIO and may cause serious infections that can lead to death. Your healthcare provider should check your white blood cell counts before and during treatment. If you develop low white blood cell counts during treatment with VERZENIO, your healthcare provider may tell you to temporarily stop taking VERZENIO, decrease your dose, or wait before starting your next month of treatment. Tell your healthcare provider right away if you have signs and symptoms of low white blood cell counts or infections, such as fever and chills. Lung problems. VERZENIO may cause severe or life-threatening inflammation of the lungs during treatment that can lead to death. If you develop lung problems during treatment with VERZENIO, your healthcare provider may tell you to temporarily stop taking VERZENIO, decrease your dose, or stop your treatment. Tell your healthcare provider right away if you have any new or worsening symptoms, including: – trouble breathing or shortness of breath – cough with or without mucus – chest pain Liver problems. VERZENIO can cause serious liver problems. […]
From the patient leaflet: What should I avoid during treatment with VERZENIO?Avoid taking ketoconazole during treatment with VERZENIO. Tell your healthcare provider if you take a medicine that contains ketoconazole. Avoid grapefruit and products that contain grapefruit during treatment with VERZENIO. Grapefruit may increase the amount of VERZENIO in your blood.
From the patient leaflet: How should I store VERZENIO?Store VERZENIO at room temperature between 68°F to 77°F (20°C to 25°C). Keep VERZENIO and all medicines out of the reach of children.
Source: FDA drug label (Verzenio), Eli Lilly and Company, effective July 13, 2026 (SPL set be4bc0de-0fdc-4d46-8d25-be43c79e6a06), via openFDA; the full label on DailyMed
Is there a generic for abemaciclib (Verzenio)?
No generic abemaciclib is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 1 patent for Verzenio tablets: the compound patent runs to September 28, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2017 earliest approval on file
- 2031 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the abemaciclib label say about other medicines?
The abemaciclib label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name abemaciclib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Ketoconazole | drug interactions | DRUG INTERACTIONS CYP3A Inhibitors: Avoid concomitant use of ketoconazole. |
| Loperamide | warnings and precautions | Instruct patients to start antidiarrheal therapy such as loperamide at the first sign of loose stools, increase oral fluids, and notify their healthcare provider for further instructions and appropriate follow up [see Patient Counseling Information ( 17 )]. |
Other labels that name abemaciclib
Source: FDA drug label (Verzenio), Eli Lilly and Company, effective July 13, 2026 (SPL set be4bc0de-0fdc-4d46-8d25-be43c79e6a06), via openFDA; the full label on DailyMed
What else is labeled for the same conditions as abemaciclib?
17 other medicines are given the same way (oral) and in the same FDA class as abemaciclib or labeled mainly for the same use (breast cancer), the same class first. Breast cancer lists all 44 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Everolimus | Breast cancer | 14 labelers | $26.32 per tablet 10 mg tablet | A presentation being discontinued |
| Palbociclib | Breast cancer | none listed | n/a | A presentation being discontinued |
| Lapatinib ditosylate | Breast cancer | 3 labelers | n/a | No current entry |
| Ribociclib | Breast cancer | none listed | $289.72 per unit 600 mg daily dose | No current entry |
| Tucatinib | Breast cancer | none listed | n/a | No current entry |
| Neratinib | Breast cancer | none listed | n/a | No current entry |
| Anastrozole | Breast cancer | 24 labelers | $0.142 per tablet 1 mg tablet | No current entry |
| Letrozole | Breast cancer | 19 labelers | $0.145 per tablet 2.5 mg tablet | No current entry |
Every medicine labeled for the same conditions as abemaciclib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to abemaciclib
- 17 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other