Delandistrogene moxeparvovec
As of the edition of 20 October 2026, Delandistrogene moxeparvovec is a gene: marketed, first approved in 2023 (US); US protection ends in 2035.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Gene
- Brand name
- Elevidys
- First approved
- 22 June 2023 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Avi Biopharma
- Registered trials
- 1, 0 stopped early
- Disease areas
- Bones, joints and muscles; Inherited and neonatal; Nervous system
US protection
US protection ends in 2035.
The reference-product exclusivity ends in 2035. The application that gives this date is held by Avi Biopharma.
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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Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 1 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Avi Biopharma | Originator and Lead sponsor of trials | 2023 to now |