AZFICEL-T
As of the edition of 20 October 2026, AZFICEL-T is a cell: marketed, first approved in 2011 (US); US protection ended in 2023.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Cell
- Brand name
- Laviv
- First approved
- 21 June 2011 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Fibrocell Technologies
- Registered trials
- 8, 1 stopped early
- Disease areas
- Bones, joints and muscles; Skin and connective tissue
US protection
US protection ended in 2023.
US protection ended in 2023, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Fibrocell Technologies. The date is computed, not published.
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 2 | 4 | 3 | 0 | 1 |
| Phase 3 | 3 | 3 | 0 | 0 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 8 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Fibrocell Technologies | Applicant | 2011 to now |