Trazodone
As of the edition of 20 October 2026, Trazodone is a small molecule: marketed, first approved in 1982 (US); acts on HTR2A and HTR2C; US protection ends in 2029.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1982
- Kind
- Small molecule
- Brand name
- Desyrel
- First approved
- 1 January 1982 (US)
- Approvals on record
- 7 in 1 region
- Holder of the most recent approval
- Kamat Pharmatech; 3 holders in all
- Registered trials
- 39, 7 stopped early
- Disease areas
- Mental health; Nervous system; Lungs and airways; Urinary and reproductive; Chemically induced; Hormones
US protection
US protection ends in 2029.
The last listed US drug-substance patent ends in 2029. The application that gives this date is held by Pragma 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 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
1 company-target row on route B because of this drug.
Companies on route B for this drug
In the product1 company-target row is on route B because of Trazodone.
See the 1 company-target row 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 | 7 | 4 | 1 | 1 |
| Phase 1 | 11 | 9 | 0 | 2 |
| Phase 2 | 7 | 4 | 3 | 0 |
| Phase 3 | 7 | 4 | 1 | 2 |
| Phase 4 | 7 | 3 | 2 | 2 |
| All trials | 39 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Labopharm | Later holder and Lead sponsor of trials | 2005 to now |
| Angelini Pharma | Acquired holder | 2013 to now |
| Pragma Pharmaceuticals | Acquired holder | 2015 to now |
| Kamat Pharmatech | Later holder | 2024 to now |
| Bristol Myers Squibb | Earlier holder |