Florbetaben
As of the edition of 20 October 2026, Florbetaben is a small molecule: marketed, first approved in 2014 (EU); US protection ends in 2029.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Neuraceq
- First approved
- 20 February 2014 (EU)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Lantheus Biosciences; 2 holders in all
- Registered trials
- 31, 2 stopped early
- Disease areas
- Nervous system; Mental health; Nutrition and metabolism; Inherited and neonatal; Cancer; Immune system
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 Lantheus Biosciences.
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.
See the exact date and the 1 listing behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 9 | 7 | 2 | 0 |
| Phase 1 | 11 | 4 | 6 | 1 |
| Phase 2 | 8 | 4 | 3 | 1 |
| Phase 3 | 2 | 2 | 0 | 0 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 31 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Lantheus Biosciences | Acquired holder and Lead sponsor of trials | 2008 to now |
| Lantheus | Applicant and Lead sponsor of trials | 2014 to now |
| Piramal Imaging | Applicant and Lead sponsor of trials | 2014 to now |