TheraRadar
Data updated: Mar 29, 2026

SITAVIG

ACYCLOVIR
Approved 2013-04-12
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
12
Years on Market

Details

Status
Discontinued
First Approved
2013-04-12
Routes
BUCCAL
Dosage Forms
TABLET

Companies

LIGAND PHARMS
Active Ingredient: ACYCLOVIR

SITAVIG Approval History

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What SITAVIG Treats

1 FDA approvals

Originally approved for its first indication in 2013 .

  • Other (1)
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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.

SITAVIG FDA Label Details

Pro

SITAVIG Patents & Exclusivity

Latest Patent: Jun 2030

Patents (3 active)

US8592434 Expires Jun 16, 2030
US8747896 Expires Jun 3, 2027
US8791127 Expires Mar 23, 2027
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA203791 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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