Prescription medicine
Bosutinib Brand names: Bosulif
Bosutinib (Bosulif) is a prescription medicine with an FDA approval on record since 2012. FDA's NDC Directory lists it from 3 generic labelers.
- Generic listed
Check it at the source: the bosutinib FDA label on DailyMed (effective March 10, 2026, Pfizer Laboratories Div Pfizer Inc); the NDA 203341 record on Drugs@FDA; every bosutinib label on DailyMed.
Highlights of the record
FDA label of March 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageBOSULIF is indicated for the treatment of:
Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies ( 14.1 , 14.2 , 14.3 )].
Forms and strengths
- 50 mg
- 100 mg
- 400 mg
- 500 mg
Film-coated tablet; capsule.
On the market
- Earliest approval on file
- September 4, 2012 Bosulif, Pf Prism Cv; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first May 23, 2025; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 3 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- August 28, 2034 Bosulif 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
- 8,931 through July 30, 2026
What is bosutinib used for?
From the label: indications and usageBOSULIF is indicated for the treatment of:
Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies ( 14.1 , 14.2 , 14.3 )].
Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy [see Clinical Studies (14.2) ]. BOSULIF is a kinase inhibitor indicated for the treatment of
adult and pediatric patients 1 year of age and older with chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy. […]
Conditions named in the indications of bosutinib's FDA labels, with every medicine labeled for each:
From other bosutinib labelsLeukemia, lymphoma and myeloma: Bosutinib tablets are a kinase inhibitor indicated for the treatment of adult patients with chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy. …
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (BOSULIF), NDA203341 (Pf Prism Cv), as published by Pfizer Laboratories Div Pfizer Inc, effective March 10, 2026 (SPL set adc84ad5-a04d-4fee-9ba8-91f7abd928e3), via openFDA; the full label on DailyMed
Is there a generic for bosutinib (Bosulif)?
The FDA approved the first generic bosutinib on May 23, 2025. 2 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists bosutinib from 3 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 4 patents for Bosulif tablets: the compound patent runs to November 23, 2026 (pediatric exclusivity to May 23, 2027), and the last listed entry to August 28, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2012 earliest approval on file
- 2025 first generic approved
- 2034 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the bosutinib label say about other medicines?
The bosutinib label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 3 other medicines name bosutinib. 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 |
|---|---|---|
| Imatinib | warnings and precautions | In a randomized study of adult patients with newly diagnosed CML, cardiac failure occurred in 1.9% of patients treated with BOSULIF compared to 0.8% of patients treated with imatinib. |
Other labels that name bosutinib
Source: FDA drug label (BOSULIF), NDA203341 (Pf Prism Cv), as published by Pfizer Laboratories Div Pfizer Inc, effective March 10, 2026 (SPL set adc84ad5-a04d-4fee-9ba8-91f7abd928e3), via openFDA; the full label on DailyMed
What do FAERS reports show for bosutinib?
The FDA Adverse Event Reporting System holds 8,931 reports that list bosutinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 782 are coded as a death and 1,918 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 bosutinib?
37 other medicines are given the same way (oral) and in the same FDA class as bosutinib 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 |
| Ibrutinib | Leukemia, lymphoma and myeloma | none listed | 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)
How does bosutinib compare with medicines for the same use?
3 side-by-side pages set bosutinib beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to bosutinib
- 37 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Bosutinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other