Data updated: Mar 10, 2026
BRAFTOVI
ENCORAFENIB
Approved 2018-06-27
9
Indications
--
Phase 3 Trials
2
Priority Reviews
7
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2018-06-27
- Routes
- ORAL
- Dosage Forms
- CAPSULE
BRAFTOVI Approval History
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What BRAFTOVI Treats
9 FDA approvalsOriginally approved for its first indication in 2018 . Covers 9 distinct patient populations.
- Other (9)
Other
(9 approvals)- • Approved indication (Jun 2018)Label Letter
- • Approved indication (Jan 2019)Label Letter
- • Approved indication (May 2019)Label Letter
- • Approved indication (Apr 2020) PriorityLabel Letter
- • Approved indication (Oct 2023)Label Letter
- • Approved indication (Sep 2024)Label Letter
- • Approved indication (Dec 2024) PriorityLabel Letter
- • Approved indication (Mar 2025) NewLabel Letter
- • Approved indication (Feb 2026) NewLabel
🔬
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.
BRAFTOVI FDA Label Details
ProBRAFTOVI Patents & Exclusivity
Latest Patent: Aug 2033
Exclusivity: Oct 2030
Patents (82 active)
US9474754
Expires Aug 5, 2033
US9763941
Expires Nov 21, 2032
US10258622
Expires Nov 21, 2032
US9387208
Expires Nov 21, 2032
US9314464
Expires Jul 4, 2031
US10005761
Expires Aug 27, 2030
US9850230
Expires Aug 27, 2030
US9850229
Expires Aug 27, 2030
US9593099
Expires Aug 27, 2030
US9593100
Expires Aug 27, 2030
+ 72 more patents
Exclusivity
I-928
Until Oct 2026
I-957
Until Dec 2027
ODE-445
Until Oct 2030
I-928
Until Oct 2026
I-957
Until Dec 2027
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.