TheraRadar
Data updated: May 26, 2026

UKONIQ (umbralisib tosylate)

Orphan Drug Breakthrough Therapy Priority Review Accelerated Approval
Oncology Approved 2021-02-05
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
5
Years on Market

Details

Status
Discontinued
First Approved
2021-02-05
Patent Cliff
2035

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Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET

Companies

TG THERAPS
Active Ingredient: UMBRALISIB TOSYLATE

UKONIQ Approval History

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

What UKONIQ Treats

1 FDA approvals

Originally approved for its first indication in 2021 .

  • 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.

UKONIQ FDA Label Details

View full patent landscape →
8 OB patents · 2 families · 116 international docs across 33 countries

UKONIQ Patents & Exclusivity

Latest Patent: May 2035
Exclusivity: Feb 2026

Patents (8 active)

US9969740 Expires May 26, 2035
US10414773 Expires May 26, 2035
US10947244 Expires May 26, 2035
US10072013 Expires Jul 2, 2033
US10570142 Expires Jul 2, 2033
US9669033 Expires Jul 2, 2033
US10981919 Expires Jul 2, 2033
US9150579 Expires Jul 2, 2033

Exclusivity

NCE Until Feb 2026
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2035
  • • 15 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: NDA213176 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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