Donidalorsen sodium
As of the edition of 20 October 2026, Donidalorsen sodium is an oligonucleotide: marketed, first approved in 2025 (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 2025
- Kind
- Oligonucleotide
- Brand name
- Dawnzera (autoinjector)
- First approved
- 21 August 2025 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Akcea Therapeutics
US protection
US protection ends in 2035.
The last listed US drug-substance patent ends in 2035. The application that gives this date is held by Akcea 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
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Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Akcea Therapeutics | Originator | 2025 to now |