TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

ENTECAVIR

ENTECAVIR
Approved 2014-08-26
Jump to: Indications Approvals Trials Competitors Safety Patents
18
Indications
--
Phase 3 Trials
11
Years on Market

Details

Status
Discontinued
First Approved
2014-08-26
Routes
ORAL
Dosage Forms
TABLET

Companies

SUNSHINE CONBA USA CHARTWELL RX AMNEAL PHARMS ZYDUS PHARMS PRINSTON INC HETERO LABS LTD V Aurobindo Pharma YUNG SHIN PHARM Cipla BRECKENRIDGE SWISS PHARM YAOPHARMA CO LTD BRIGHTGENE RISING Teva ACCORD HLTHCARE
Active Ingredient: ENTECAVIR

ENTECAVIR Approval History

Loading approval history...

What ENTECAVIR Treats

18 FDA approvals

Originally approved for its first indication in 2014 . Covers 18 distinct patient populations.

  • Other (18)
🔬

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.

ENTECAVIR FDA Label Details

Pro

Want competitive intelligence?

See who's developing similar drugs and track their progress

View Pipeline Dashboard

Data Sources

FDA Approval: ANDA211978 → Trials: ClinicalTrials.gov →

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