TheraRadar
Data updated: May 26, 2026

DAWNZERA (AUTOINJECTOR) (donidalorsen sodium)

First-in-Class Orphan Drug
Rare Disease Approved 2025-08-21
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
Prescription
First Approved
2025-08-21
Patent Cliff
2035

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Patent cliff and revenue data

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Routes
SUBCUTANEOUS
Dosage Forms
SOLUTION

Companies

IONIS PHARMS INC
Active Ingredient: DONIDALORSEN SODIUM

DAWNZERA (AUTOINJECTOR) Approval History

2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2025 to 2025
Aug 2025 ORIGINAL
New Drug · Type 1 - New Molecular Entity
FDA Letter Label

What DAWNZERA (AUTOINJECTOR) Treats

1 FDA approvals

Originally approved for its first indication in 2025 .

  • Other (1)
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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

DAWNZERA (AUTOINJECTOR) FDA Label Details

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5 OB patents · 4 families · 467 international docs across 41 countries

DAWNZERA (AUTOINJECTOR) Patents & Exclusivity

Latest Patent: May 2035

Patents (5 active)

US10294477 Expires May 1, 2035
US9670492 Expires Aug 28, 2034
US9127276 Expires May 1, 2034
US9181549 Expires May 1, 2034
US9315811 Expires Oct 21, 2032
Source: FDA Orange Book

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Revenue Insights

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Patent Timeline

  • • Cliff: 2035
  • • 5 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

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  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA219407 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.