TheraRadar
Data updated: May 26, 2026

LEXETTE (halobetasol propionate)

Dermatology Approved 2018-05-24
2
Indications
--
Phase 3 Trials
8
Years on Market

Details

Status
Discontinued
First Approved
2018-05-24
Patent Cliff
2037

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Patent cliff and revenue data

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Routes
TOPICAL
Dosage Forms
AEROSOL, FOAM

Companies

Active Ingredient: HALOBETASOL PROPIONATE

LEXETTE Approval History

2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
5 FDA actions from 2018 to 2022 · 1 indication expansions
Jul 2022 SUPPL
Label · Labeling
Aug 2021 SUPPL
Efficacy
Apr 2020 SUPPL
Label · Labeling

What LEXETTE Treats

2 FDA approvals

Originally approved for its first indication in 2018 . Covers 2 distinct patient populations.

  • Other (2)
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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT03298581 71542610 Ph 2 withdrawn Multiple-Dose Pharmacokinetics and Potential for Adrenal Suppression Following Treatment With Halobetasol Spray in Patients With Plaque Psoriasis
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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

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.

LEXETTE FDA Label Details

View full patent landscape →
3 OB patents · 2 families · 42 international docs across 16 countries

LEXETTE Patents & Exclusivity

Latest Patent: May 2037

Patents (3 active)

US10857159*PED Expires May 30, 2037
US11020407 Expires Nov 30, 2036
US10857159 Expires Nov 30, 2036
Source: FDA Orange Book

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Revenue Insights

  • Quarterly revenue tracking
  • Historical trend analysis

Patent Timeline

  • Cliff: 2037
  • 3 active patents

Trial Analysis

  • Clinical trial tracking
  • Development stage analysis

Competitive Landscape

  • Competitor tracking
  • Same target/indication analysis
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Data Sources

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