TheraRadar
Data updated: May 26, 2026

NETSPOT (gallium dotatate ga-68)

Oncology Approved 2016-06-01

NETSPOT is a radioactive diagnostic tool used during PET imaging to help locate neuroendocrine tumors in both adult and pediatric patients. It helps clinicians identify specific malignant cells that express somatostatin receptors on their surface. This agent is used to visualize the presence and position of these tumors throughout the body.

Source: FDA Label • AAA USA INC

How NETSPOT Works

This agent works by binding to somatostatin receptors, particularly subtype 2, which are often found in high concentrations on the surface of neuroendocrine tumor cells. Once attached, the gallium-68 isotope emits signals that are captured during a PET scan. This process allows for the precise localization of malignant cells that overexpress these specific receptors.

1
Indication
--
Phase 3 Trials
1
Priority Reviews
9
Years on Market

Details

Status
Prescription
First Approved
2016-06-01
Patent Cliff
2032

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Routes
INTRAVENOUS
Dosage Forms
POWDER

Companies

Active Ingredient: GALLIUM DOTATATE GA-68

NETSPOT Approval History

2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
11 FDA actions from 2016 to 2023
Oct 2023 SUPPL
Label · Labeling
Dec 2021 SUPPL
Label · Labeling
Jun 2021 SUPPL
Label · Labeling

What NETSPOT Treats

1 indications

NETSPOT is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Neuroendocrine Tumors
Source: FDA Label

NETSPOT Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

2

Same target(s) AND same indication — head-to-head.

MoA expansion candidates

2

Same target(s), different indications — where else is this mechanism being explored?

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to NETSPOT

3 of 4

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

AFINITOR
EVEROLIMUS
1 shared
Novartis
Shared indications:
Neuroendocrine Tumors
AFINITOR DISPERZ
EVEROLIMUS
1 shared
Novartis
Shared indications:
Neuroendocrine Tumors
DETECTNET
COPPER CU-64 DOTATATE
1 shared
CURIUM
Shared indications:
Neuroendocrine Tumors
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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

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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.

NETSPOT FDA Label Details

Indications & Usage

FDA Label (PDF)

NETSPOT is indicated for the treatment of Neuroendocrine Tumors.

View full patent landscape →
1 OB patents · 1 families · 49 international docs across 20 countries

NETSPOT Patents & Exclusivity

Latest Patent: Aug 2032

Patents (1 active)

US9375498 Expires Aug 10, 2032
Source: FDA Orange Book

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Patent Timeline

  • Cliff: 2032
  • 1 active patents

Trial Analysis

  • Clinical trial tracking
  • Development stage analysis

Competitive Landscape

  • 4 similar drugs
  • 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.