Betibeglogene autotemcel
As of the edition of 20 October 2026, Betibeglogene autotemcel is a gene: marketed, first approved in 2022 (US); US protection ends in 2034.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Gene
- Brand name
- Zynteglo
- First approved
- 17 August 2022 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Bluebird Bio
- Withdrawn from market
- 24 March 2022 (in some regions)
- Registered trials
- 1, 0 stopped early
- Disease areas
- Blood and lymph; Inherited and neonatal
US protection
US protection ends in 2034.
The reference-product exclusivity ends in 2034. The application that gives this date is held by Bluebird Bio.
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 2 | 1 | 1 | 0 | 0 |
| All trials | 1 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bluebird Bio | Originator, Applicant and Lead sponsor of trials | 2013 to now |