Data updated: Jun 28, 2026
Rare Disease
Approved 2023-12-21
2
Indications
--
Phase 3 Trials
2
Years on Market
Details
- Status
- Prescription
- First Approved
- 2023-12-21
- Patent Cliff
- 2034
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
WAINUA (AUTOINJECTOR) Approval History
2024
2025
2026
Original
New Indication
New Form
Label Update
5 FDA actions from 2023 to 2026 · 1 indication expansions
What WAINUA (AUTOINJECTOR) Treats
2 FDA approvalsOriginally approved for its first indication in 2023 . Covers 2 distinct patient populations.
- Other (2)
AstraZeneca's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
BEYFORTUS
2023 NIRSEVIMAB-ALIP
1 designation
TRUQAP
2023 CAPIVASERTIB
3 designations
IMJUDO
2022 TREMELIMUMAB-ACTL
1 designation
SAPHNELO
2021 ANIFROLUMAB-FNIA
2 designations
TEZSPIRE
2021 TEZEPELUMAB-EKKO
2 designations
KOSELUGO
2020 SELUMETINIB
4 designations
LOKELMA
2018 SODIUM ZIRCONIUM CYCLOSILICATE
CALQUENCE
2017 ACALABRUTINIB
4 designations
IMFINZI
2017 DURVALUMAB
3 designations
FASENRA
2017 BENRALIZUMAB
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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
View full patent landscape →
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
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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
Data sourced from official FDA and NIH databases. Click links to verify on original sources.