TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

BRUKINSA

ZANUBRUTINIB
Approved 2019-11-14
Jump to: Indications Approvals Trials Competitors Safety Patents
7
Indications
--
Phase 3 Trials
2
Priority Reviews
6
Years on Market

Details

Status
Discontinued
First Approved
2019-11-14
Routes
ORAL
Dosage Forms
CAPSULE, TABLET

Companies

BEONE MEDICINES USA
Active Ingredient: ZANUBRUTINIB

BRUKINSA Approval History

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What BRUKINSA Treats

7 FDA approvals

Originally approved for its first indication in 2019 . Covers 7 distinct patient populations.

  • Other (7)
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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.

BRUKINSA FDA Label Details

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BRUKINSA Patents & Exclusivity

Latest Patent: Jan 2043
Exclusivity: Mar 2031

Patents (206 active)

US11911386 Expires Jan 19, 2043
US11786531 Expires Jan 19, 2043
US11896596 Expires Jan 19, 2043
US12233069 Expires Jun 10, 2040
US11701357 Expires Jun 24, 2039
US11884674 Expires Aug 15, 2037
US11591340 Expires Aug 15, 2037
US11970500 Expires Aug 15, 2037
US11851437 Expires Aug 15, 2037
US10927117 Expires Aug 15, 2037
+ 196 more patents

Exclusivity

I-817 Until Jan 2026
I-936 Until Mar 2027
ODE-274 Until Jan 2030
ODE-276 Until Nov 2026
ODE-370 Until Sep 2028
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA213217 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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