Lemborexant
As of the edition of 20 October 2026, Lemborexant is a small molecule: marketed, first approved in 2020 (JP); acts on HCRTR1 and HCRTR2; US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Dayvigo
- First approved
- 23 January 2020 (JP)
- Approvals on record
- 6 in 3 regions
- Holder of the most recent approval
- Eisai
- Registered trials
- 49, 2 stopped early
- Disease areas
- Nervous system; Mental health; Lungs and airways; Chemically induced; Nutrition and metabolism; Digestive system
US protection
US protection ends in 2031.
The last listed US drug-substance patent ends in 2031. 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 product4 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
2 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Lemborexant.
See the 2 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 | 5 | 1 | 3 | 0 |
| Phase 1 | 18 | 18 | 0 | 0 |
| Phase 2 | 16 | 5 | 9 | 2 |
| Phase 3 | 5 | 4 | 0 | 0 |
| Phase 4 | 5 | 2 | 3 | 0 |
| All trials | 49 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Eisai | Applicant and Lead sponsor of trials | 2011 to now |