Fidanacogene elaparvovec
As of the edition of 20 October 2026, Fidanacogene elaparvovec 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
- Beqvez
- First approved
- 25 April 2024 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Pfizer
- Withdrawn from market
- 15 May 2025 (in some regions)
- Registered trials
- 4, 1 stopped early
- Disease areas
- Blood and lymph; Inherited and neonatal
US protection
US protection ends in 2036.
The reference-product exclusivity ends in 2036. The application that gives this date is held by Pfizer.
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 1 | 1 | 0 | 0 | 1 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 1 | 0 | 1 | 0 |
| All trials | 4 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Originator and Lead sponsor of trials | 2015 to now |