Tasimelteon
As of the edition of 20 October 2026, Tasimelteon is a small molecule: marketed, first approved in 2014 (US); acts on MTNR1A and MTNR1B; 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
- Hetlioz
- First approved
- 31 January 2014 (US)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Vanda Pharmaceuticals; 2 holders in all
- Registered trials
- 27, 1 stopped early
- Disease areas
- Mental health; Nervous system; Occupational diseases; Eye; Inherited and neonatal; Digestive system
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 Vanda Pharmaceuticals.
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 product12 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 Tasimelteon.
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 1 | 11 | 10 | 0 | 1 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 13 | 8 | 3 | 0 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 27 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Vanda Pharmaceuticals | Originator, Applicant and Lead sponsor of trials | 2004 to now |