TheraRadar
Data updated: Jun 28, 2026

TEKTURNA (aliskiren hemifumarate) · NODEN PHARMA

Cardiovascular Approved 2007-03-05

TEKTURNA is FDA-approved to treat 3 conditions (same as ALISKIREN HEMIFUMARATE).

2
Indications
--
Phase 3 Trials
1
Priority Reviews
19
Years on Market

Details

Status
Discontinued
First Approved
2007-03-05
Patent Cliff
2026

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
CAPSULE, PELLET, TABLET

Companies

Active Ingredient: ALISKIREN HEMIFUMARATE

TEKTURNA Approval History

2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
39 FDA actions from 2007 to 2020
Jun 2020 SUPPL
Label · Labeling
Nov 2017 ORIGINAL Priority
New Form · Type 3 - New Dosage Form
Nov 2016 SUPPL
Label · Labeling

What TEKTURNA Treats

3 indications

TEKTURNA is approved for 3 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as ALISKIREN HEMIFUMARATE (same active ingredient).

Source: FDA Label
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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

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.

TEKTURNA FDA Label Details

Indications & Usage

FDA Label (PDF)

TEKTURNA is FDA-approved to treat 3 conditions — same approved indications as ALISKIREN HEMIFUMARATE.

View full patent landscape →
2 OB patents · 1 families · 54 international docs across 24 countries

TEKTURNA Patents & Exclusivity

Latest Patent: Aug 2026

Patents (2 active)

US8617595*PED Expires Aug 19, 2026
US8617595 Expires Feb 19, 2026
Source: FDA Orange Book

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Revenue Insights

  • Quarterly revenue tracking
  • Historical trend analysis

Patent Timeline

  • Cliff: 2026
  • 8 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.