Elivaldogene autotemcel
As of the edition of 20 October 2026, Elivaldogene 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
- Skysona
- First approved
- 16 September 2022 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Bluebird Bio
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.
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Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bluebird Bio | Originator and Applicant | 2022 to now |