Data updated: May 26, 2026
GALLIUM GA 68 EDOTREOTIDE (gallium ga-68 edotreotide)
Oncology
Approved 2019-08-21
2
Indications
--
Phase 3 Trials
6
Years on Market
Details
- Status
- Prescription
- First Approved
- 2019-08-21
- Patent Cliff
- 2026
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
GALLIUM GA 68 EDOTREOTIDE Approval History
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2019 to 2025
Oct 2025 ORIGINAL
Update
What GALLIUM GA 68 EDOTREOTIDE Treats
2 FDA approvalsOriginally approved for its first indication in 2019 . Covers 2 distinct patient populations.
- Other (2)
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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.
GALLIUM GA 68 EDOTREOTIDE FDA Label Details
GALLIUM GA 68 EDOTREOTIDE Patents & Exclusivity
Exclusivity: Aug 2026
Exclusivity
ODE-383
Until Aug 2026
W
Until Aug 2026
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.