Prescription medicine
Donidalorsen Brand names: Dawnzera; first approved as Dawnzera (Autoinjector)
Donidalorsen (Dawnzera) is a prescription medicine with an FDA approval on record since 2025. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the donidalorsen FDA label on DailyMed (effective September 24, 2025, Ionis Pharmaceuticals Inc.); the NDA 219407 record on Drugs@FDA; every donidalorsen label on DailyMed.
Highlights of the record
FDA label of September 24, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageDAWNZERA™ is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older.
Forms and strengths
- 80 mg/.8ml
Injection (solution).
On the market
- Earliest approval on file
- August 21, 2025 Dawnzera (Autoinjector), Ionis Pharms Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- May 1, 2035 Dawnzera injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 302 through July 30, 2026
What is donidalorsen used for?
From the label: indications and usageDAWNZERA™ is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. DAWNZERA is a prekallikrein directed antisense oligonucleotide indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older.
Source: FDA drug label (DAWNZERA), Ionis Pharmaceuticals Inc., effective September 24, 2025 (SPL set 3ff501e0-f75f-07da-e063-6294a90a0cb7), via openFDA; the full label on DailyMed
Is there a generic for donidalorsen (Dawnzera)?
No generic donidalorsen is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 5 patents for Dawnzera injection: the compound patent runs to May 1, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2025 earliest approval on file
- 2035 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for donidalorsen?
The FDA Adverse Event Reporting System holds 302 reports that list donidalorsen among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 15 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Donidalorsen side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other