Afamitresgene autoleucel
As of the edition of 20 October 2026, Afamitresgene autoleucel is a gene: marketed, first approved in 2024 (US); acts on MAGEA4; 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
- tecelra
- First approved
- 1 August 2024 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- Uswm Ct
US protection
US protection ends in 2036.
The reference-product exclusivity ends in 2036. The application that gives this date is held by Uswm Ct.
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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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Afamitresgene autoleucel.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| MAGEA4 | Melanoma-associated antigen 4 | P43358 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Uswm Ct | Acquired holder | 2026 to now |
| Adaptimmune | Originator | 2024 to 2026 |