TheraRadar
Data updated: May 26, 2026

BYDUREON BCISE (exenatide synthetic)

Metabolic Approved 2017-10-20
Jump to: Indications Approvals Trials Competitors Safety Patents
4
Indications
--
Phase 3 Trials
1
Priority Reviews
8
Years on Market

Details

Status
Discontinued
First Approved
2017-10-20
Patent Cliff
2031

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Patent cliff and revenue data

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Routes
SUBCUTANEOUS
Dosage Forms
SUSPENSION, EXTENDED RELEASE

Companies

AstraZeneca
Active Ingredient: EXENATIDE SYNTHETIC

BYDUREON BCISE Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
18 FDA actions from 2017 to 2025 · 3 indication expansions
May 2025 SUPPL
Label · Labeling
FDA Letter Label
Nov 2024 SUPPL
Label · Labeling
FDA Letter Label
Mar 2024 SUPPL
Label · Labeling
FDA Letter Label

What BYDUREON BCISE Treats

4 FDA approvals

Originally approved for its first indication in 2017 . Covers 4 distinct patient populations.

  • Other (4)
🔬

Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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 BCISE FDA Label Details

View full patent landscape →
14 OB patents · 5 families · 414 international docs across 47 countries

BYDUREON BCISE Patents & Exclusivity

Latest Patent: Apr 2031

Patents (14 active)

US8895033*PED Expires Apr 4, 2031
US8895033 Expires Oct 4, 2030
US8361972*PED Expires Sep 21, 2028
US8361972 Expires Mar 21, 2028
US8501698*PED Expires Dec 20, 2027
US8501698 Expires Jun 20, 2027
US8906851*PED Expires Feb 18, 2027
US8329648*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

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2031
  • • 47 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA209210 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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