TheraRadar
Data updated: May 26, 2026

OMONTYS PRESERVATIVE FREE (peginesatide acetate)

Renal Approved 2012-03-27
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
14
Years on Market

Details

Status
Discontinued
First Approved
2012-03-27
Patent Cliff
2026

Pro Metrics

Patent cliff and revenue data

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Routes
INTRAVENOUS, SUBCUTANEOUS
Dosage Forms
SOLUTION

Companies

Takeda
Active Ingredient: PEGINESATIDE ACETATE

OMONTYS PRESERVATIVE FREE Approval History

2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
12 FDA actions from 2012 to 2012
Dec 2012 SUPPL
Label · Labeling
FDA Letter Label
Mar 2012 ORIGINAL
New Drug · Type 1 - New Molecular Entity
FDA Letter Label

What OMONTYS PRESERVATIVE FREE Treats

1 FDA approvals

Originally approved for its first indication in 2012 .

  • 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.

OMONTYS PRESERVATIVE FREE FDA Label Details

View full patent landscape →
2 OB patents · 2 families · 33 international docs across 20 countries

OMONTYS PRESERVATIVE FREE Patents & Exclusivity

Latest Patent: Jun 2026

Patents (2 active)

US7550433 Expires Jun 2, 2026
US7919461 Expires Jun 2, 2026
Source: FDA Orange Book

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Deep insights for OMONTYS PRESERVATIVE FREE

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2026
  • • 96 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA202799 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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