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
OXBRYTA Approval History
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What OXBRYTA Treats
2 FDA approvalsOriginally approved for its first indication in 2019 . Covers 2 distinct patient populations.
- Other (2)
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
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
ProOXBRYTA 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.