TheraRadar
Data updated: May 26, 2026

VYLEESI (AUTOINJECTOR) (bremelanotide acetate)

First-in-Class
Women's Health Approved 2019-06-21
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
6
Years on Market

Details

Status
Prescription
First Approved
2019-06-21
Patent Cliff
2041

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Patent cliff and revenue data

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Routes
SUBCUTANEOUS
Dosage Forms
SOLUTION

Companies

COSETTE
Active Ingredient: BREMELANOTIDE ACETATE

VYLEESI (AUTOINJECTOR) Approval History

2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2019 to 2020
Oct 2020 SUPPL
Label · Labeling
FDA Letter Label
Jun 2019 ORIGINAL
New Drug · Type 1 - New Molecular Entity
FDA Letter Label

What VYLEESI (AUTOINJECTOR) Treats

1 FDA approvals

Originally approved for its first indication in 2019 .

  • Other (1)
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Active Pipeline

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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.

VYLEESI (AUTOINJECTOR) FDA Label Details

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4 OB patents · 2 families · 55 international docs across 24 countries

VYLEESI (AUTOINJECTOR) Patents & Exclusivity

Latest Patent: Apr 2041

Patents (4 active)

US11590209 Expires Apr 29, 2041
US9352013 Expires Nov 5, 2033
US9700592 Expires Nov 5, 2033
US10286034 Expires Nov 5, 2033
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2041
  • • 4 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: NDA210557 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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