TheraRadar
Data updated: May 26, 2026

TRUSELTIQ (infigratinib phosphate)

Orphan Drug Priority Review Accelerated Approval Fast Track
Oncology Approved 2021-05-28
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
4
Years on Market

Details

Status
Discontinued
First Approved
2021-05-28
Patent Cliff
2034

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
CAPSULE

Companies

HELSINN HLTHCARE
Active Ingredient: INFIGRATINIB PHOSPHATE

TRUSELTIQ Approval History

2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2021 to 2021
May 2021 ORIGINAL Priority
New Drug · Type 1 - New Molecular Entity
FDA Letter Label

What TRUSELTIQ Treats

1 FDA approvals

Originally approved for its first indication in 2021 .

  • Other (1)
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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT05514912 STUDY00004206 NCI-2022-05975, STUDY00004206 Ph 2 withdrawn Preoperative Nab-paclitaxel, Cisplatin, and Gemcitabine Chemotherapy With or Without Infigratinib Targeted Therapy for the Treatment of Resectable Intrahepatic Cholangiocarcinoma, The OPTIC Trial
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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.

TRUSELTIQ FDA Label Details

View full patent landscape →
4 OB patents · 3 families · 164 international docs across 41 countries

TRUSELTIQ Patents & Exclusivity

Latest Patent: Dec 2034
Exclusivity: May 2028

Patents (4 active)

US10278969 Expires Dec 11, 2034
US11160804 Expires Dec 11, 2034
US8552002 Expires Aug 25, 2029
US9067896 Expires Aug 6, 2028

Exclusivity

NCE Until May 2026
ODE-353 Until May 2028
NCE Until May 2026
ODE-353 Until May 2028
NCE Until May 2026
ODE-353 Until May 2028
NCE Until May 2026
ODE-353 Until May 2028
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2034
  • • 16 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA214622 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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