Prescription medicine
Tepotinib Brand names: Tepmetko
Tepotinib (Tepmetko) 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 tepotinib FDA label on DailyMed (effective April 17, 2025, EMD Serono, Inc.); the NDA 214096 record on Drugs@FDA; every tepotinib label on DailyMed.
Highlights of the record
FDA label of April 17, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageTEPMETKO is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping alterations.
Forms and strengths
- 225 mg
Tablet.
On the market
- Earliest approval on file
- February 3, 2021 Tepmetko, Emd Serono Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- March 19, 2030 Tepmetko 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
- 642 through July 30, 2026
What is tepotinib used for?
From the label: indications and usageTEPMETKO is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping alterations. TEPMETKO is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping alterations.
Conditions named in the indications of tepotinib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (TEPMETKO), EMD Serono, Inc., effective April 17, 2025 (SPL set 80a0f1b9-071a-47f5-9e67-32d638a669dc), via openFDA; the full label on DailyMed
What does the patient leaflet for tepotinib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about TEPMETKO?TEPMETKO may cause serious side effects, including: Lung problems. TEPMETKO may cause severe or life-threatening swelling (inflammation) of the lungs during treatment that can lead to death. Tell your healthcare provider right away if you develop any new or worsening symptoms of lung problems, including: trouble breathing shortness of breath cough fever See " What are possible side effects of TEPMETKO? " for more information about side effects.
From the patient leaflet: How should I store TEPMETKO?Store TEPMETKO at room temperature between 68°F to 77°F (20°C to 25°C). TEPMETKO tablets come in blister cards with a child-resistant blister foil. Store TEPMETKO in original package. Keep TEPMETKO and all medicines out of the reach of children.
Source: FDA drug label (TEPMETKO), EMD Serono, Inc., effective April 17, 2025 (SPL set 80a0f1b9-071a-47f5-9e67-32d638a669dc), via openFDA; the full label on DailyMed
Is there a generic for tepotinib (Tepmetko)?
No generic tepotinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 8 patents for Tepmetko tablets: the compound patent runs to March 19, 2030. 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
- 2030 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for tepotinib?
The FDA Adverse Event Reporting System holds 642 reports that list tepotinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 158 are coded as a death and 173 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 tepotinib?
26 other medicines are given the same way (oral) and in the same FDA class as tepotinib 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 |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to tepotinib
- 26 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Tepotinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other