Prescription medicine
Asciminib Brand names: Scemblix
Asciminib (Scemblix) is a prescription medicine with an FDA approval on record since 2021. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the asciminib FDA label on DailyMed (effective November 25, 2025, Novartis Pharmaceuticals Corporation); the NDA 215358 record on Drugs@FDA; every asciminib label on DailyMed.
Highlights of the record
FDA label of November 25, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageSCEMBLIX is indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
Forms and strengths
- 20 mg
- 40 mg
- 100 mg
Film-coated tablet.
On the market
- Earliest approval on file
- October 29, 2021 Scemblix, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- May 17, 2040 Scemblix 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 asciminib used for?
From the label: indications and usageSCEMBLIX is indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). Previously treated Ph+ CML in CP. Ph+ CML in CP with the T315I mutation. SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). […]
Conditions named in the indications of asciminib's FDA labels, with every medicine labeled for each:
Source: FDA drug label (SCEMBLIX), Novartis Pharmaceuticals Corporation, effective November 25, 2025 (SPL set e33001e7-3650-42b1-ae56-cddb5c43aa2b), via openFDA; the full label on DailyMed
Is there a generic for asciminib (Scemblix)?
No generic asciminib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Scemblix tablets: the compound patent runs to May 14, 2040, and the last listed entry to May 17, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2021 earliest approval on file
- 2040 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the asciminib label say about other medicines?
The asciminib label names 2 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Itraconazole | drug interactions | DRUG INTERACTIONS Strong CYP3A4 Inhibitors: Closely monitor for adverse reactions during concomitant use of SCEMBLIX at 200 mg twice daily. ( 7.1 ) Itraconazole Oral Solution Containing Hydroxypropyl-β-cyclodextrin: |
| Rosuvastatin | drug interactions | Avoid concomitant use with rosuvastatin at all recommended doses. |
Source: FDA drug label (SCEMBLIX), Novartis Pharmaceuticals Corporation, effective November 25, 2025 (SPL set e33001e7-3650-42b1-ae56-cddb5c43aa2b), via openFDA; the full label on DailyMed
What else is labeled for the same conditions as asciminib?
37 other medicines are given the same way (oral) and in the same FDA class as asciminib 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 |
|---|---|---|---|---|
| Lenalidomide | Leukemia, lymphoma and myeloma | 18 labelers | n/a | No current entry |
| Dasatinib | Leukemia, lymphoma and myeloma | 14 labelers | $26.46 per tablet 100 mg tablet | No current entry |
| Pomalidomide | Leukemia, lymphoma and myeloma | 11 labelers | n/a | No current entry |
| Imatinib | Leukemia, lymphoma and myeloma | 20 labelers | $0.624 per tablet 100 mg tablet | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | none listed | n/a | A presentation being discontinued |
| Nilotinib | Leukemia, lymphoma and myeloma | 6 labelers | n/a | No current entry |
| Hydroxyurea | Leukemia, lymphoma and myeloma | 10 labelers | $0.184 per capsule 500 mg capsule | No current entry |
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 4 labelers | $1.67 per capsule 50 mg capsule | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Check an interaction
- what two or more labels say about each other