Flibanserin
As of the edition of 20 October 2026, Flibanserin is a small molecule: marketed, first approved in 2015 (US); acts on HTR1A and HTR2A; US protection ends in 2028.
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
- Addyi
- First approved
- 18 August 2015 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Sprout Pharmaceuticals
- Registered trials
- 15, 5 stopped early
- Disease areas
- Mental health; Cancer; Skin and connective tissue
US protection
US protection ends in 2028.
The last listed US exclusivity ends in 2028. The application that gives this date is held by Sprout 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 product1 listing counts 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 Flibanserin.
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 | 2 | 2 | 0 | 0 |
| Phase 2 | 2 | 1 | 1 | 0 |
| Phase 3 | 10 | 6 | 0 | 4 |
| Phase 4 | 1 | 0 | 0 | 1 |
| All trials | 15 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sprout Pharmaceuticals | Originator and Lead sponsor of trials | 2006 to now |