Data updated: Mar 10, 2026
WAINUA (AUTOINJECTOR)
EPLONTERSEN SODIUM
Approved 2023-12-21
1
Indication
--
Phase 3 Trials
2
Years on Market
Details
- Status
- Prescription
- First Approved
- 2023-12-21
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
WAINUA (AUTOINJECTOR) Approval History
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What WAINUA (AUTOINJECTOR) Treats
1 FDA approvalsOriginally approved for its first indication in 2023 .
- Other (1)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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
ProWAINUA (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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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.