Lenvatinib
As of the edition of 20 October 2026, Lenvatinib is a small molecule: marketed, first approved in 2015 (US); acts on FLT1, FLT4 and KDR; US protection ends in 2035.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2015
- Kind
- Small molecule
- Brand name
- Lenvima
- First approved
- 13 February 2015 (US)
- Approvals on record
- 20 in 5 regions
- Holder of the most recent approval
- Eisai
- Registered trials
- 483, 41 stopped early
- Disease areas
- Cancer; Digestive system; Urinary and reproductive; Pregnancy and women's health; Hormones; Skin and connective tissue
US protection
US protection ends in 2035.
The last listed US drug-substance patent ends in 2035. The application that gives this date is held by Eisai.
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 product18 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
3 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product3 company-target rows are on route B because of Lenvatinib.
See the 3 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 52 | 13 | 18 | 2 |
| Phase 1 | 51 | 28 | 11 | 4 |
| Phase 2 | 313 | 71 | 163 | 29 |
| Phase 3 | 58 | 19 | 25 | 6 |
| Phase 4 | 9 | 2 | 4 | 0 |
| All trials | 483 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Eisai | Originator and Lead sponsor of trials | 2009 to now |