TheraRadar
Data updated: May 26, 2026

VYNDAQEL (tafamidis meglumine)

First-in-Class Orphan Drug Breakthrough Therapy Priority Review Fast Track
Other Approved 2019-05-03
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
7
Years on Market

Details

Status
Discontinued
First Approved
2019-05-03
Patent Cliff
2026

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
CAPSULE

Companies

FOLDRX PHARMS
Active Ingredient: TAFAMIDIS MEGLUMINE

VYNDAQEL Approval History

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

What VYNDAQEL Treats

1 FDA approvals

Originally approved for its first indication in 2019 .

  • Other (1)
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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT04828993 results posted B3461078 Ph 4 completed The Effect Of Tafamidis Meglumine In Transthyretin Amyloid Polyneuropathy Patients
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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.

VYNDAQEL FDA Label Details

View full patent landscape →
2 OB patents · 1 families · 75 international docs across 20 countries

VYNDAQEL Patents & Exclusivity

Latest Patent: Dec 2026
Exclusivity: May 2026

Patents (2 active)

US7214696 Expires Dec 19, 2026
US7214695 Expires Dec 19, 2026

Exclusivity

ODE-237 Until May 2026
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2026
  • • 2 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: NDA211996 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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