TheraRadar
Data updated: May 26, 2026

PYLARIFY TRUVU (piflufolastat f-18)

Approved 2026-03-06
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
Prescription
First Approved
2026-03-06
Patent Cliff
2037

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Patent cliff and revenue data

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Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

APHELION
Active Ingredient: PIFLUFOLASTAT F-18

PYLARIFY TRUVU Approval History

Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
Mar 2026 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer
Label

What PYLARIFY TRUVU Treats

1 FDA approvals

Originally approved for its first indication in 2026 .

  • Other (1)
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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.

PYLARIFY TRUVU FDA Label Details

PYLARIFY TRUVU Patents & Exclusivity

Latest Patent: Jun 2037
Exclusivity: May 2026

Patents (6 active)

US11851407 Expires Jun 9, 2037
US10947197 Expires Jun 9, 2037
US8778305 Expires Sep 21, 2030
US12070513 Expires Jul 31, 2029
US9861713 Expires Jul 31, 2029
US8487129 Expires Nov 7, 2027

Exclusivity

NCE Until May 2026
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2037
  • • 6 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: NDA220089 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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