Prescription medicine
Imatinib Brand names: Gleevec, Imkeldi
Imatinib (Gleevec) is a prescription medicine with an FDA approval on record since 2001. FDA's NDC Directory lists it from 20 generic labelers, and pharmacies paid $0.624 per imatinib mesylate 100 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the imatinib FDA label on DailyMed (effective September 8, 2026, Apotex Corp); the NDA 21335 record on Drugs@FDA; every imatinib label on DailyMed.
Highlights of the record
FDA label of September 8, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageImatinib mesylate is a kinase inhibitor indicated for the treatment of:
Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase ( 1.1 )
Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy ( 1.2
Forms and strengths
- 100 mg
- 400 mg
- 80 mg/ml
Film-coated tablet; tablet; solution.
On the market
- Earliest approval on file
- May 10, 2001 Gleevec, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 16 first December 3, 2015; 12 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 22 of which 20 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- April 27, 2040 Imkeldi oral solution; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.624 per tablet Imatinib mesylate 100 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2018 0 Class I among all firms' recalls; latest February 17, 2021
- FAERS reports
- 41,417 through July 30, 2026
What is imatinib used for?
From the label: indications and usageImatinib mesylate is a kinase inhibitor indicated for the treatment of:
Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase ( 1.1 )
Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy ( 1.2 )
Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) ( 1.3 )
Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy ( 1.4 )
Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. […]
Conditions named in the indications of imatinib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (Imatinib Mesylate), Apotex Corp, effective September 8, 2026 (SPL set 0291eca5-7a1d-4a79-30be-252224d96509), via openFDA; the full label on DailyMed
Is there a generic for imatinib (Gleevec)?
The FDA approved the first generic imatinib on December 3, 2015. 16 generic applications are approved; 12 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists imatinib from 20 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 no patent for Gleevec tablets; a patent listed only for Imkeldi oral solution runs to April 27, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2001 earliest approval on file
- 2015 first generic approved
- 2040 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for imatinib (Gleevec)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.624 per Imatinib mesylate 100 mg tablet, down 32% from $0.925 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Imatinib mesylate 100 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Imatinib mesylate 100 mg tablet | Generic | $0.624 per tablet | $18.73 | -32% |
| Imatinib mesylate 400 mg tablet | Generic | $2.68 per tablet | $80.31 | -11% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has imatinib been recalled?
The FDA's Enforcement Report lists 4 recalls naming imatinib since 2018: 0 Class I (the most serious), 4 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 17, 2021 | Class II | Dr. Reddy's Laboratories, Inc. | Failed Dissolution Specifications |
| December 8, 2020 | Class II | Shilpa Medicare Limited | CGMP Deviations |
| April 3, 2018 | Class II | Kroger Specialty Pharmacy, Inc. | Lack of Processing Controls. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the imatinib label say about other medicines?
The imatinib label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 15 other medicines name imatinib. 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 |
|---|---|---|
| Heparin | drug interactions | … ( 7.3 , 7.4 , 12.3 ) Patients who require anticoagulation should receive low-molecular weight or standard heparin and not warfarin. ( 7.3 ) Imatinib mesylate tablets delay the clearance of methotrexate when methotrexate is used at high doses (> 500 mg/m 2 ). |
| Levothyroxine | warnings and precautions | Hypothyroidism has been reported in thyroidectomy patients undergoing levothyroxine replacement. |
| Methotrexate | drug interactions | … low-molecular weight or standard heparin and not warfarin. ( 7.3 ) Imatinib mesylate tablets delay the clearance of methotrexate when methotrexate is used at high doses (> 500 mg/m 2 ). |
| Nilotinib | warnings and precautions | In a randomized trial in patients with newly diagnosed Ph+CML in chronic phase comparing imatinib mesylate and nilotinib, severe (Grade 3 or 4) fluid retention occurred in 2.5% of patients receiving imatinib mesylate and in 3.9% of patients receiving nilotinib 300 mg twice daily. |
| Rifampin | drug interactions | CYP2D6 substrates: Consider alternative therapeutic agents with less enzyme induction potential in patients when rifampin or other strong CYP3A4 inducers are indicated for concomitant use with Imkeldi. |
| Warfarin | drug interactions | … 12.3 ) Patients who require anticoagulation should receive low-molecular weight or standard heparin and not warfarin. ( 7.3 ) Imatinib mesylate tablets delay the clearance of methotrexate when methotrexate is used at high doses (> 500 mg/m 2 ). |
Other labels that name imatinib
Source: FDA drug label (Imatinib Mesylate), Apotex Corp, effective September 8, 2026 (SPL set 0291eca5-7a1d-4a79-30be-252224d96509), via openFDA; the full label on DailyMed
What do FAERS reports show for imatinib?
The FDA Adverse Event Reporting System holds 41,417 reports that list imatinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 8,912 are coded as a death and 9,005 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 imatinib?
37 other medicines are given the same way (oral) and in the same FDA class as imatinib 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 |
| Nilotinib | Leukemia, lymphoma and myeloma | 6 labelers | n/a | No current entry |
| Bosutinib | Leukemia, lymphoma and myeloma | 3 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 imatinib compare with medicines for the same use?
3 side-by-side pages set imatinib beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to imatinib
- 37 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Imatinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other