Nadofaragene firadenovec
As of the edition of 20 October 2026, Nadofaragene firadenovec 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 2026
- Kind
- Gene
- Brand name
- Adstiladrin
- First approved
- 16 December 2022 (US)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Ferring Pharmaceuticals; 2 holders in all
- Registered trials
- 11, 2 stopped early
- Disease areas
- Cancer; Pregnancy and women's health; Urinary and reproductive
US protection
US protection ends in 2034.
The reference-product exclusivity ends in 2034. The application that gives this date is held by Ferring Pharmaceuticals.
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 product1 listing counts 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 not stated | 1 | 0 | 0 | 1 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 3 | 1 | 2 | 0 |
| Phase 3 | 5 | 1 | 4 | 0 |
| Phase 4 | 1 | 0 | 0 | 1 |
| All trials | 11 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Ferring Pharmaceuticals | Originator, Applicant and Lead sponsor of trials | 2016 to now |