TheraRadar
Data updated: May 26, 2026

BYDUREON PEN (exenatide synthetic)

Metabolic Approved 2012-01-27
Jump to: Indications Approvals Trials Competitors Safety Patents
6
Indications
--
Phase 3 Trials
1
Priority Reviews
14
Years on Market

Details

Status
Discontinued
First Approved
2012-01-27
Patent Cliff
2028

Pro Metrics

Patent cliff and revenue data

Unlock with Pro
Routes
SUBCUTANEOUS
Dosage Forms
FOR SUSPENSION, EXTENDED RELEASE

Companies

AstraZeneca
Active Ingredient: EXENATIDE SYNTHETIC

BYDUREON PEN Approval History

2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
31 FDA actions from 2012 to 2025 · 5 indication expansions
May 2025 SUPPL
Label · Labeling
FDA Letter Label
Nov 2024 SUPPL
Label · Labeling
FDA Letter Label
Dec 2022 SUPPL
Label · Labeling
FDA Letter Label

What BYDUREON PEN Treats

6 FDA approvals

Originally approved for its first indication in 2012 . Covers 6 distinct patient populations.

  • Other (6)
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
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

View full patent landscape →
12 OB patents · 4 families · 361 international docs across 46 countries

BYDUREON PEN Patents & Exclusivity

Latest Patent: Sep 2028

Patents (12 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
US6515117*PED Expires Apr 4, 2026
US6515117 Expires Oct 4, 2025
Source: FDA Orange Book

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
Unlock Full Intelligence

Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA022200 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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