Birch triterpenes
As of the edition of 20 October 2026, Birch triterpenes is a small molecule: marketed, first approved in 2022 (EU); US protection ends in 2030.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Small molecule
- Brand name
- Filsuvez
- First approved
- 21 June 2022 (EU)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Chiesi Farmaceutici
- Withdrawn from market
- 7 June 2022 (in some regions)
- Registered trials
- 5, 0 stopped early
- Disease areas
- Inherited and neonatal; Skin and connective tissue; Injuries
US protection
US protection ends in 2030.
The last listed US exclusivity ends in 2030. The application that gives this date is held by Chiesi Farmaceutici.
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 product2 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 2 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 1 | 0 |
| Phase 2 | 1 | 0 | 1 | 0 |
| Phase 3 | 3 | 3 | 0 | 0 |
| All trials | 5 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Chiesi Farmaceutici | Applicant | 2022 to now |