Amifampridine
As of the edition of 20 October 2026, Amifampridine is a small molecule: marketed, first approved in 2009 (EU); US protection ends in 2029.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Small molecule
- Brand name
- Firdapse
- First approved
- 23 December 2009 (EU)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- DyDo Pharma, Inc.; 4 holders in all
- Registered trials
- 14, 2 stopped early
- Disease areas
- Nervous system; Cancer; Immune system; Inherited and neonatal; Chemically induced; Ear, nose and throat
US protection
US protection ends in 2029.
The last listed US exclusivity ends in 2029. The application that gives this date is held by Angelini Pharma.
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 | 5 | 0 | 0 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 3 | 2 | 0 | 1 |
| Phase 3 | 5 | 4 | 0 | 1 |
| All trials | 14 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Serb | Applicant | 2009 to now |
| Angelini Pharma | Applicant and Lead sponsor of trials | 2016 to now |
| Jacobus Pharmaceutical | Later holder | 2019 to now |