TheraRadar
Data updated: May 26, 2026

WAINUA (AUTOINJECTOR) (eplontersen sodium)

Orphan Drug
Rare Disease Approved 2023-12-21
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
2
Years on Market

Details

Status
Prescription
First Approved
2023-12-21
Patent Cliff
2034

Pro Metrics

Patent cliff and revenue data

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Routes
SUBCUTANEOUS
Dosage Forms
SOLUTION

Companies

AstraZeneca
Active Ingredient: EPLONTERSEN SODIUM

WAINUA (AUTOINJECTOR) Approval History

2024
2025
2026
Original
New Indication
New Form
Label Update
5 FDA actions from 2023 to 2026 · 1 indication expansions
Apr 2026 SUPPL
Efficacy
FDA Letter Label
Dec 2025 SUPPL
Label · Labeling
FDA Letter
Apr 2025 SUPPL
Label · Labeling
FDA Letter Label

What WAINUA (AUTOINJECTOR) Treats

2 FDA approvals

Originally approved for its first indication in 2023 . Covers 2 distinct patient populations.

  • Other (2)
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Active Pipeline

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Ongoing clinical trials by development phase

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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.

WAINUA (AUTOINJECTOR) FDA Label Details

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4 OB patents · 2 families · 390 international docs across 41 countries

WAINUA (AUTOINJECTOR) Patents & Exclusivity

Latest Patent: Aug 2034
Exclusivity: Dec 2030

Patents (4 active)

US10683499 Expires Aug 25, 2034
US9127276 Expires May 1, 2034
US9181549 Expires May 1, 2034
US8101743 Expires Apr 1, 2026

Exclusivity

NCE Until Dec 2028
ODE-461 Until Dec 2030
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2034
  • • 4 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA217388 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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