TheraRadar
Data updated: May 26, 2026

LEVITRA (vardenafil hydrochloride)

Urology Approved 2003-08-19
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
22
Years on Market

Details

Status
Discontinued
First Approved
2003-08-19
Patent Cliff
2027

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Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET

Companies

Bayer
Active Ingredient: VARDENAFIL HYDROCHLORIDE

LEVITRA Approval History

2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
56 FDA actions from 2003 to 2023 · 1 indication expansions
Mar 2023 SUPPL
Label · Labeling
Label
Aug 2017 SUPPL
Label · Labeling
FDA Letter Label
Sep 2015 SUPPL
Label · Labeling
FDA Letter Label

What LEVITRA Treats

2 FDA approvals

Originally approved for its first indication in 2003 . Covers 2 distinct patient populations.

  • Other (2)
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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.

LEVITRA FDA Label Details

View full patent landscape →
1 OB patents · 1 families · 67 international docs across 32 countries

LEVITRA Patents & Exclusivity

Latest Patent: Jul 2027

Patents (1 active)

US8273876 Expires Jul 23, 2027
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2027
  • • 16 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: NDA021400 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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