Prescription medicine
Ibrutinib Brand names: Imbruvica
Ibrutinib (Imbruvica) is a prescription medicine with an FDA approval on record since 2013. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the ibrutinib FDA label on DailyMed (effective October 21, 2025); the NDA 205552 record on Drugs@FDA; every ibrutinib label on DailyMed.
Highlights of the record
FDA label of October 21, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageIMBRUVICA is a kinase inhibitor indicated for the treatment of: Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) ( 1.1 ).
Forms and strengths
- 70 mg
- 140 mg
- 280 mg
- 420 mg
- 70 mg/ml
Film-coated tablet; capsule; suspension.
On the market
- Earliest approval on file
- November 13, 2013 Imbruvica, Pharmacyclics Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first March 31, 2021; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- September 3, 2036 Imbruvica 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
- FAERS reports
- 80,310 through July 30, 2026
What is ibrutinib used for?
From the label: indications and usageIMBRUVICA is a kinase inhibitor indicated for the treatment of: Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) ( 1.1 ). Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion ( 1.2 ). Adult patients with Waldenström’s macroglobulinemia (WM) ( 1.3 ). […]
Conditions named in the indications of ibrutinib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (Imbruvica), Pharmacyclics LLC, effective October 21, 2025 (SPL set 0dfd0279-ff17-4ea9-89be-9803c71bab44), via openFDA; the full label on DailyMed
What does the patient leaflet for ibrutinib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking IMBRUVICA?You should not drink grapefruit juice, eat grapefruit, or eat Seville oranges (often used in marmalades) during treatment with IMBRUVICA. These products may increase the amount of IMBRUVICA in your blood.
From the patient leaflet: How should I store IMBRUVICA?Store IMBRUVICA capsules and tablets at room temperature between 68°F and 77°F (20°C and 25°C). Keep IMBRUVICA capsules in the original container with the lid tightly closed. Keep IMBRUVICA tablets in the original carton. Store IMBRUVICA oral suspension bottle between 36°F and 77°F (2°C and 25°C). Do not freeze. Use IMBRUVICA oral suspension within 60 days after first opening the bottle. Throw away (dispose of) any unused portion 60 days after opening. IMBRUVICA capsules and oral suspension come in a bottle with a child-resistant cap. Keep IMBRUVICA and all medicines out of the reach of children.
Source: FDA drug label (Imbruvica), Pharmacyclics LLC, effective October 21, 2025 (SPL set 0dfd0279-ff17-4ea9-89be-9803c71bab44), via openFDA; the full label on DailyMed
Is there a generic for ibrutinib (Imbruvica)?
The FDA approved the first generic ibrutinib on March 31, 2021. 2 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 6 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 38 patents for Imbruvica tablets: the compound patent runs to October 30, 2033 (pediatric exclusivity to April 30, 2034), and the last listed entry to September 3, 2036; a patent listed only for Imbruvica oral suspension runs to June 14, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2013 earliest approval on file
- 2021 first generic approved
- 2036 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the ibrutinib label say about other medicines?
The ibrutinib label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 8 other medicines name ibrutinib. 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 |
|---|---|---|
| Posaconazole | drug interactions | Dose modifications of IMBRUVICA are recommended when used concomitantly with posaconazole, voriconazole and moderate CYP3A inhibitors [see Dosage and Administration ( 2.3 )]. |
| Voriconazole | drug interactions | Dose modifications of IMBRUVICA are recommended when used concomitantly with posaconazole, voriconazole and moderate CYP3A inhibitors [see Dosage and Administration ( 2.3 )]. |
Other labels that name ibrutinib
Source: FDA drug label (Imbruvica), Pharmacyclics LLC, effective October 21, 2025 (SPL set 0dfd0279-ff17-4ea9-89be-9803c71bab44), via openFDA; the full label on DailyMed
What do FAERS reports show for ibrutinib?
The FDA Adverse Event Reporting System holds 80,310 reports that list ibrutinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 13,715 are coded as a death and 26,719 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ibrutinib?
37 other medicines are given the same way (oral) and in the same FDA class as ibrutinib or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 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 |
|---|---|---|---|---|
| Dasatinib | Leukemia, lymphoma and myeloma | 14 labelers | $26.46 per tablet 100 mg tablet | No current entry |
| Imatinib | Leukemia, lymphoma and myeloma | 20 labelers | $0.624 per tablet 100 mg tablet | No current entry |
| Nilotinib | Leukemia, lymphoma and myeloma | 6 labelers | n/a | No current entry |
| Bosutinib | Leukemia, lymphoma and myeloma | 3 labelers | n/a | No current entry |
| Ponatinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Acalabrutinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Pirtobrutinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Quizartinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to ibrutinib
- 37 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Ibrutinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other