Cerliponase alfa
As of the edition of 20 October 2026, Cerliponase alfa is an enzyme: marketed, first approved in 2017 (US); US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Enzyme
- Brand name
- Brineura
- First approved
- 27 April 2017 (US)
- Approvals on record
- 5 in 4 regions
- Holder of the most recent approval
- Amicus Therapeutics; 2 holders in all
- Registered trials
- 5, 0 stopped early
- Disease areas
- Inherited and neonatal; Nervous system; Nutrition and metabolism
US protection
US protection ends in 2031.
The orphan exclusivity ends in 2031 (it covers one use only). The application that gives this date is held by Amicus Therapeutics.
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 not stated | 1 | 0 | 1 | 0 |
| Phase 2 | 4 | 3 | 1 | 0 |
| All trials | 5 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Amicus Therapeutics | Applicant and Lead sponsor of trials | 2013 to now |