Asenapine
As of the edition of 20 October 2026, Asenapine is a small molecule: marketed, first approved in 2009 (US); acts on HTR2A; 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
- Saphris
- First approved
- 13 August 2009 (US)
- Approvals on record
- 9 in 4 regions
- Holder of the most recent approval
- Hisamitsu Pharmaceutical; 5 holders in all
- Registered trials
- 46, 2 stopped early
- Disease areas
- Mental health; Nervous system; Hormones; Inherited and neonatal; Pregnancy and women's health; Urinary and reproductive
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 AbbVie.
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 product15 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 15 listings behind itRequest access. Nothing is shown until you do.
Companies that need a new molecule because of this drug
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Asenapine.
See the 3 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| HTR2A | 5-hydroxytryptamine receptor 2A | P28223 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 2 | 0 | 1 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 2 | 1 | 0 | 1 |
| Phase 3 | 32 | 31 | 0 | 0 |
| Phase 4 | 7 | 5 | 1 | 0 |
| All trials | 46 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Organon | Originator, Applicant and Lead sponsor of trials | 2003 to now |
| Meiji Seika Pharma | Applicant | 2016 to now |
| Hisamitsu Pharmaceutical | Later holder | 2019 to now |
| AbbVie | Acquired holder | 2026 to now |