Tolvaptan
As of the edition of 20 October 2026, Tolvaptan is a small molecule: marketed, first approved in 2009 (US); acts on AVPR2; US protection ended in 2026.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2016
- Kind
- Small molecule
- Brand name
- Samsca
- First approved
- 19 May 2009 (US)
- Approvals on record
- 26 in 5 regions
- Holder of the most recent approval
- Otsuka; 2 holders in all
- Registered trials
- 88, 11 stopped early
- Disease areas
- Pregnancy and women's health; Urinary and reproductive; Heart and blood vessels; Nutrition and metabolism; Inherited and neonatal; Hormones
US protection
US protection ended in 2026.
The last listed US drug-substance patent ended in 2026. The application that gives this date is held by Otsuka.
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 product8 listings count towards this date. The exact date and each listing are in the product.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| AVPR2 | Vasopressin V2 receptor | P30518 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 13 | 5 | 1 | 2 |
| Phase 1 | 10 | 10 | 0 | 0 |
| Phase 2 | 20 | 18 | 0 | 1 |
| Phase 3 | 32 | 25 | 1 | 5 |
| Phase 4 | 13 | 9 | 0 | 3 |
| All trials | 88 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Otsuka | Originator, Applicant and Lead sponsor of trials | 2002 to now |