Data updated: Mar 10, 2026
BYDUREON PEN
EXENATIDE SYNTHETIC
Approved 2012-01-27
6
Indications
--
Phase 3 Trials
1
Priority Reviews
14
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2012-01-27
- Routes
- SUBCUTANEOUS
- Dosage Forms
- FOR SUSPENSION, EXTENDED RELEASE
BYDUREON PEN Approval History
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What BYDUREON PEN Treats
6 FDA approvalsOriginally approved for its first indication in 2012 . Covers 6 distinct patient populations.
- Other (6)
Other
(6 approvals) 🔬
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.
BYDUREON PEN FDA Label Details
ProBYDUREON PEN Patents & Exclusivity
Latest Patent: Sep 2028
Patents (72 active)
US8361972*PED
Expires Sep 21, 2028
US8361972
Expires Mar 21, 2028
US8501698*PED
Expires Dec 20, 2027
US8501698
Expires Jun 20, 2027
US8329648*PED
Expires Feb 18, 2027
US8906851*PED
Expires Feb 18, 2027
US9884092*PED
Expires Feb 18, 2027
US8329648
Expires Aug 18, 2026
US8906851
Expires Aug 18, 2026
US9884092
Expires Aug 18, 2026
+ 62 more patents
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.