TheraRadar
Data updated: May 26, 2026

LYMPHOSEEK KIT (technetium tc-99m tilmanocept)

Oncology Approved 2013-03-13
Jump to: Indications Approvals Trials Competitors Safety Patents
4
Indications
--
Phase 3 Trials
1
Priority Reviews
13
Years on Market

Details

Status
Prescription
First Approved
2013-03-13
Patent Cliff
2029

Pro Metrics

Patent cliff and revenue data

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Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

CARDINAL HEALTH 414
Active Ingredient: TECHNETIUM TC-99M TILMANOCEPT

LYMPHOSEEK KIT Approval History

2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
8 FDA actions from 2013 to 2021 · 3 indication expansions
May 2021 SUPPL
Efficacy
FDA Letter Label
Jul 2019 SUPPL
Label · Labeling
FDA Letter Label
Nov 2016 SUPPL
Mfg · Manufacturing (CMC)

What LYMPHOSEEK KIT Treats

4 FDA approvals

Originally approved for its first indication in 2013 . Covers 4 distinct patient populations.

  • Other (4)
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Active Pipeline

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Ongoing clinical trials by development phase

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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

ClinicalTrials.gov ↗ Pro

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.

LYMPHOSEEK KIT FDA Label Details

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1 OB patents · 1 families · 30 international docs across 9 countries

LYMPHOSEEK KIT Patents & Exclusivity

Latest Patent: Jan 2029

Patents (1 active)

US9439985 Expires Jan 30, 2029
Source: FDA Orange Book

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Deep insights for LYMPHOSEEK KIT

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2029
  • • 1 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA202207 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.