TheraRadar
Data updated: May 26, 2026

NEURACEQ (florbetaben f-18)

Positron Emitting Activity
CNS Approved 2014-03-19

NEURACEQ (florbetaben F-18) is a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment. It is used to assist in the evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline, and to identify patients who are candidates for amyloid beta-directed therapies.

Source: FDA Label • LANTHEUS • Radioactive Diagnostic Agent

How NEURACEQ Works

Florbetaben F-18 is a radiopharmaceutical that binds to β-amyloid plaques in the brain. The Fluorine-18 isotope decays by positron emission; the resulting photons (gamma rays) are detected by a PET scanner. The intensity of the signal correlates with the density of amyloid beta neuritic plaques in the brain, allowing for visual and quantitative assessment of plaque burden.

2
Indications
--
Phase 3 Trials
12
Years on Market

Details

Status
Prescription
First Approved
2014-03-19
Patent Cliff
2032

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Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

Active Ingredient: FLORBETABEN F-18

NEURACEQ Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
19 FDA actions from 2014 to 2025
Jun 2025 SUPPL
Label · Labeling
Oct 2023 SUPPL
Label · Labeling
Jun 2022 SUPPL
Mfg · Manufacturing (CMC)

What NEURACEQ Treats

2 indications

NEURACEQ is approved for 2 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Alzheimer's Disease
  • Cognitive Decline
Source: FDA Label

NEURACEQ Competitive Set

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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 NEURACEQ

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

AMYVID
FLORBETAPIR F-18
2 shared
AVID RADIOPHARMS INC
Shared indications:
Alzheimer's DiseaseCognitive Decline
VIZAMYL
FLUTEMETAMOL F-18
2 shared
GE HEALTHCARE
Shared indications:
Alzheimer's DiseaseCognitive Decline
ARICEPT
DONEPEZIL HYDROCHLORIDE
1 shared
EISAI INC
Shared indications:
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Active Pipeline

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Key Completed Trials

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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.

NEURACEQ FDA Label Details

Indications & Usage

FDA Label (PDF)

NEURACEQ is indicated for the treatment of Alzheimer's Disease; Cognitive Decline.

View full patent landscape →
2 OB patents · 2 families · 80 international docs across 30 countries

NEURACEQ Patents & Exclusivity

Latest Patent: Jul 2032

Patents (2 active)

US9308284 Expires Jul 14, 2032
US7807135 Expires Mar 18, 2029
Source: FDA Orange Book

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Patent Timeline

  • Cliff: 2032
  • 2 active patents

Trial Analysis

  • Clinical trial tracking
  • Development stage analysis

Competitive Landscape

  • 10 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.