Tepotinib
As of the edition of 20 October 2026, Tepotinib is a small molecule: marketed, first approved in 2020 (JP); acts on MET; US protection ends in 2030.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Tepmetko
- First approved
- 25 March 2020 (JP)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- Merck KGaA; 4 holders in all
- Registered trials
- 29, 3 stopped early
- Disease areas
- Cancer; Lungs and airways; Digestive system; Blood and lymph; Nervous system; Skin and connective tissue
US protection
US protection ends in 2030.
The last listed US drug-substance patent ends in 2030. The application that gives this date is held by Merck KGaA.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product5 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 5 listings behind itRequest access. Nothing is shown until you do.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Tepotinib.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| MET | Hepatocyte growth factor receptor | P08581 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 13 | 10 | 2 | 1 |
| Phase 2 | 15 | 4 | 6 | 2 |
| Phase 3 | 1 | 0 | 1 | 0 |
| All trials | 29 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck KGaA | Originator, Applicant and Lead sponsor of trials | 2009 to now |