TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

OXBRYTA

VOXELOTOR
Approved 2019-11-25
2
Indications
--
Phase 3 Trials
2
Priority Reviews
6
Years on Market

Details

Status
Discontinued
First Approved
2019-11-25
Routes
ORAL
Dosage Forms
TABLET, FOR SUSPENSION, TABLET

Companies

Active Ingredient: VOXELOTOR

OXBRYTA Approval History

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What OXBRYTA Treats

2 FDA approvals

Originally approved for its first indication in 2019 . Covers 2 distinct patient populations.

  • Other (2)
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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

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.

OXBRYTA FDA Label Details

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OXBRYTA Patents & Exclusivity

Latest Patent: Oct 2037
Exclusivity: Dec 2028

Patents (76 active)

US10493035 Expires Oct 12, 2037
US11020382 Expires Dec 2, 2036
US11944612 Expires Dec 2, 2036
US11452720 Expires Feb 6, 2035
US10722502 Expires Feb 6, 2035
US9447071 Expires Feb 6, 2035
US9248199 Expires Jan 29, 2034
US9018210 Expires Nov 25, 2033
US10034879 Expires Dec 28, 2032
US10017491 Expires Dec 28, 2032
+ 66 more patents

Exclusivity

ODE* Until Nov 2026
ODE-394 Until Dec 2028
ODE* Until Nov 2026
ODE-394 Until Dec 2028
ODE-281 Until Nov 2026
Source: FDA Orange Book

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Data Sources

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