Prescription medicine
Dasatinib Brand names: Sprycel, Phyrago
Dasatinib (Sprycel) is a prescription medicine with an FDA approval on record since 2006. FDA's NDC Directory lists it from 14 generic labelers, and pharmacies paid $26.46 per dasatinib 100 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the dasatinib FDA label on DailyMed (effective November 12, 2025, Alembic Pharmaceuticals Limited); the NDA 22072 record on Drugs@FDA; every dasatinib label on DailyMed.
Highlights of the record
FDA label of November 12, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageDasatinib tablet is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
Forms and strengths
- 20 mg
- 50 mg
- 70 mg
- 80 mg
- 100 mg
- 140 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- June 28, 2006 Sprycel, Bristol Myers Squibb; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 10 first June 10, 2016; 10 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 17 of which 14 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- September 28, 2026 Sprycel tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $26.46 per tablet Dasatinib 100 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 9,103 through July 30, 2026
What is dasatinib used for?
From the label: indications and usageDasatinib tablet is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablet is indicated for the treatment of pediatric patients 1 year of age and older with
Ph+ CML in chronic phase. Additional pediatric use information is approved for Bristol-Myers Squibb Company’s Sprycel (dasatinib) tablets. […]
Conditions named in the indications of dasatinib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (DASATINIB), Alembic Pharmaceuticals Limited, effective November 12, 2025 (SPL set 645fcf26-1b2f-40c5-881b-8effe02defbd), via openFDA; the full label on DailyMed
Is there a generic for dasatinib (Sprycel)?
The FDA approved the first generic dasatinib on June 10, 2016. 10 generic applications are approved; 10 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 dasatinib from 14 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 1 patent for Sprycel tablets: the compound patent runs to March 28, 2026 (pediatric exclusivity to September 28, 2026); a patent listed only for Phyrago tablets runs to January 22, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2006 earliest approval on file
- 2016 first generic approved
- 2026 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for dasatinib (Sprycel)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $26.46 per Dasatinib 100 mg tablet, down 86% from $191.74 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. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.
- Dasatinib 100 mg tablet (generic)
- Sprycel 100 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Dasatinib 100 mg tablet | Generic | $26.46 per tablet | $793.70 | -86% |
| Sprycel 100 mg tablet | Brand | $591.18 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $17,735.44 | +0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the dasatinib label say about other medicines?
The dasatinib label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 24 other medicines name dasatinib. 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 | After 5 years of follow-up in the randomized newly diagnosed chronic phase CML trial in adults (n=258), the following cardiac adverse reactions occurred: cardiac ischemic events (3.9% dasatinib vs 1.6% imatinib), cardiac-related fluid retention (8.5% dasatinib vs 3.9% imatinib), and conduction system abnormalities … |
Other labels that name dasatinib
Source: FDA drug label (DASATINIB), Alembic Pharmaceuticals Limited, effective November 12, 2025 (SPL set 645fcf26-1b2f-40c5-881b-8effe02defbd), via openFDA; the full label on DailyMed
What do FAERS reports show for dasatinib?
The FDA Adverse Event Reporting System holds 9,103 reports that list dasatinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,338 are coded as a death and 2,784 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 dasatinib?
37 other medicines are given the same way (oral) and in the same FDA class as dasatinib 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 |
|---|---|---|---|---|
| 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 |
| 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 dasatinib compare with medicines for the same use?
3 side-by-side pages set dasatinib beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to dasatinib
- 37 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Dasatinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other