BYDUREON PEN (exenatide synthetic) · AstraZeneca
BYDUREON PEN is FDA-approved to treat 1 condition (same as BYETTA).
Details
- Status
- Discontinued
- First Approved
- 2012-01-27
- Patent Cliff
- 2028
- Routes
- SUBCUTANEOUS
- Dosage Forms
- FOR SUSPENSION, EXTENDED RELEASE
BYDUREON PEN Approval History
What BYDUREON PEN Treats
1 indicationsBYDUREON PEN is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Type 2 diabetes mellitus
Same approved indications as BYETTA (same active ingredient).
AstraZeneca's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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
Indications & Usage
FDA Label (PDF)BYDUREON PEN is FDA-approved to treat 1 condition — same approved indications as BYETTA.
BYDUREON PEN Patents & Exclusivity
Patents (12 active)
Pro Intelligence Preview
Deep insights for BYDUREON PEN
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • 72 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.