TheraRadar
Data updated: May 26, 2026

VELTASSA (patiromer sorbitex calcium)

Renal Approved 2015-10-21
Jump to: Indications Approvals Trials Competitors Safety Patents
3
Indications
--
Phase 3 Trials
10
Years on Market

Details

Status
Discontinued
First Approved
2015-10-21
Patent Cliff
2033

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
POWDER

Companies

VIFOR PHARMA
Active Ingredient: PATIROMER SORBITEX CALCIUM

VELTASSA Approval History

2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
44 FDA actions from 2015 to 2023 · 2 indication expansions
Oct 2023 SUPPL
Efficacy
Label
Mar 2023 SUPPL
Label · Labeling
FDA Letter Label
Dec 2021 SUPPL
Label · Labeling
FDA Letter Label

What VELTASSA Treats

3 FDA approvals

Originally approved for its first indication in 2015 . Covers 3 distinct patient populations.

  • Other (3)
🔬

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.

VELTASSA FDA Label Details

View full patent landscape →
7 OB patents · 4 families · 137 international docs across 15 countries

VELTASSA Patents & Exclusivity

Latest Patent: Oct 2033
Exclusivity: Oct 2026

Patents (7 active)

US9492476 Expires Oct 8, 2033
US9925212 Expires Oct 8, 2033
US11123363 Expires Oct 8, 2033
US8337824 Expires May 29, 2030
US8147873 Expires Jun 20, 2028
US8282913 Expires May 29, 2027
US8216560 Expires Mar 14, 2027

Exclusivity

NPP Until Oct 2026
NPP Until Oct 2026
NPP Until Oct 2026
NS Until Oct 2026
NPP Until Oct 2026
NPP Until Oct 2026
NPP Until Oct 2026
NS Until Oct 2026
NPP Until Oct 2026
NPP Until Oct 2026
NPP Until Oct 2026
NS Until Oct 2026
NPP Until Oct 2026
NPP Until Oct 2026
NPP Until Oct 2026
NS Until Oct 2026
Source: FDA Orange Book

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Deep insights for VELTASSA

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2033
  • • 112 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: NDA205739 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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