Prescription medicine
Capmatinib Brand names: Tabrecta
Capmatinib (Tabrecta) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the capmatinib FDA label on DailyMed (effective December 15, 2025, Novartis Pharmaceuticals Corporation); the NDA 213591 record on Drugs@FDA; every capmatinib label on DailyMed.
Highlights of the record
FDA label of December 15, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageTABRECTA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
Forms and strengths
- 150 mg
- 200 mg
Film-coated tablet.
On the market
- Earliest approval on file
- May 6, 2020 Tabrecta, Novartis Pharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- July 22, 2035 Tabrecta 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
- 2,345 through July 30, 2026
What is capmatinib used for?
From the label: indications and usageTABRECTA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. TABRECTA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
Conditions named in the indications of capmatinib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (TABRECTA), Novartis Pharmaceuticals Corporation, effective December 15, 2025 (SPL set 455892c3-d144-4ba8-9ab4-79cabff9876d), via openFDA; the full label on DailyMed
What does the patient leaflet for capmatinib 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 TABRECTA?Your skin may be sensitive to the sun (photosensitivity) during treatment with TABRECTA. Use sunscreen or wear clothes that cover your skin during your treatment with TABRECTA to limit direct sunlight exposure.
From the patient leaflet: How should I store TABRECTA?Store TABRECTA at room temperature between 68°F to 77°F (20°C to 25°C). Store TABRECTA in the original package with the drying agent (desiccant) cartridge. Protect TABRECTA from moisture. Throw away (discard) any unused TABRECTA you have left after 6 weeks of first opening the bottle. Keep TABRECTA and all medicines out of the reach of children.
Source: FDA drug label (TABRECTA), Novartis Pharmaceuticals Corporation, effective December 15, 2025 (SPL set 455892c3-d144-4ba8-9ab4-79cabff9876d), via openFDA; the full label on DailyMed
Is there a generic for capmatinib (Tabrecta)?
No generic capmatinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 7 patents for Tabrecta tablets: the compound patent runs to November 19, 2032, and the last listed entry to July 22, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2035 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the capmatinib label say about other medicines?
The capmatinib label names no other medicine on this site. The labels of 1 other medicine name capmatinib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name capmatinib
Source: FDA drug label (TABRECTA), Novartis Pharmaceuticals Corporation, effective December 15, 2025 (SPL set 455892c3-d144-4ba8-9ab4-79cabff9876d), via openFDA; the full label on DailyMed
What do FAERS reports show for capmatinib?
The FDA Adverse Event Reporting System holds 2,345 reports that list capmatinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 566 are coded as a death and 391 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 capmatinib?
26 other medicines are given the same way (oral) and in the same FDA class as capmatinib or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 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 |
|---|---|---|---|---|
| Erlotinib | Lung cancer | 10 labelers | n/a | No current entry |
| Afatinib | Lung cancer | 1 labeler | n/a | No current entry |
| Selpercatinib | Lung cancer | none listed | n/a | No current entry |
| Crizotinib | Lung cancer | none listed | n/a | No current entry |
| Gefitinib | Lung cancer | 4 labelers | n/a | No current entry |
| Brigatinib | Lung cancer | none listed | n/a | No current entry |
| Dabrafenib | Lung cancer | none listed | n/a | No current entry |
| Lorlatinib | Lung cancer | none listed | n/a | A presentation being discontinued |
Every medicine labeled for the same conditions as capmatinib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to capmatinib
- 26 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Capmatinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other