TheraRadar
Data updated: Jun 28, 2026

STAXYN (vardenafil hydrochloride) · Bayer

Urology Approved 2010-06-17

STAXYN is FDA-approved to treat 1 condition (same as VARDENAFIL HYDROCHLORIDE).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
3
Indications
--
Phase 3 Trials
16
Years on Market

Details

Status
Discontinued
First Approved
2010-06-17
Patent Cliff
2028

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Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET, ORALLY DISINTEGRATING

Companies

Bayer
Active Ingredient: VARDENAFIL HYDROCHLORIDE

STAXYN Approval History

2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
7 FDA actions from 2010 to 2023 · 2 indication expansions
Apr 2023 SUPPL
Label · Labeling
FDA Letter Label
Aug 2017 SUPPL
Label · Labeling
FDA Letter Label
Aug 2017 SUPPL
Efficacy
FDA Letter Label

What STAXYN Treats

1 indications

STAXYN is approved for 1 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Erectile Dysfunction

Same approved indications as VARDENAFIL HYDROCHLORIDE (same active ingredient).

Source: FDA Label
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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.

STAXYN FDA Label Details

Indications & Usage

FDA Label (PDF)

STAXYN is FDA-approved to treat 1 condition — same approved indications as VARDENAFIL HYDROCHLORIDE.

View full patent landscape →
1 OB patents · 1 families · 63 international docs across 39 countries

STAXYN Patents & Exclusivity

Latest Patent: Dec 2028

Patents (1 active)

US8613950 Expires Dec 23, 2028
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2028
  • • 1 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: NDA200179 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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