Atidarsagene autotemcel
As of the edition of 20 October 2026, Atidarsagene autotemcel is a gene: marketed, first approved in 2024 (US); US protection ends in 2036.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Gene
- Brand name
- Lenmeldy
- First approved
- 18 March 2024 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Kyowa Kirin
US protection
US protection ends in 2036.
The reference-product exclusivity ends in 2036. The application that gives this date is held by Kyowa Kirin.
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 |
|---|---|---|
| Kyowa Kirin | Originator | 2024 to now |