TheraRadar
Data updated: May 26, 2026

PRESTALIA (amlodipine besylate)

Cardiovascular Approved 2015-01-21
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
11
Years on Market

Details

Status
Discontinued
First Approved
2015-01-21
Patent Cliff
2029

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Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET

Companies

ADHERA
Active Ingredient: AMLODIPINE BESYLATE , PERINDOPRIL ARGININE

PRESTALIA Approval History

2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
12 FDA actions from 2015 to 2017
Sep 2017 SUPPL
Label · Labeling
FDA Letter Label
Nov 2016 SUPPL
Label · Labeling
FDA Letter Label
Aug 2015 SUPPL
Label · Labeling
FDA Letter Label

What PRESTALIA Treats

1 FDA approvals

Originally approved for its first indication in 2015 .

  • Other (1)
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Clinical Trial Registry

8 trials
Trial Sponsor ID Phase Status Title
NCT04434664 BLOCK HFpEF results posted 833517 Ph 4 completed BLOCKade of Calcium Channels and Beta Adrenergic Receptors for the Treatment of Hypertension in HFpEF
NCT04974138 CSPPT2-CC/CT CSPPT2-CC/CT_2020 Ph 4 recruiting China Stroke Primary Prevention Trial 2 for Participants With H-type Hypertension and MTHFR 677 CC/CT Genotype (CSPPT2-CC/CT)
NCT04974151 CSPPT2-TT CSPPT2-TT_2020 Ph 4 recruiting China Stroke Primary Prevention Trial 2 for Participants With Hypertension and MTHFR 677 TT Genotype
NCT05275907 STU00215781 1R56HL155093-01 Ph 4 withdrawn Mechanism of Hypertension Treatments in Liver Transplant Recipients (BLOCK LTR-HTN)
NCT02940548 NARRAS 2016PHB013-02 Ph 4 terminated Nifedipine GITS and Amlodipine Besylate on Recovery of Blood Pressure Rhythm and Arterial Stiffness
NCT01302691 results posted 0954E-357 Ph 3 completed MK-0954E Study in Participants With Hypertension (MK-0954E-357)
NCT02353806 results posted 042014-059 UL1TR001105 Ph 4 completed Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation
NCT01556997 PATH results posted X985400 Ph 3 completed Perindopril Amlodipine for the Treatment of Hypertension
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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.

PRESTALIA FDA Label Details

View full patent landscape →
1 OB patents · 1 families · 39 international docs across 28 countries

PRESTALIA Patents & Exclusivity

Latest Patent: Oct 2029

Patents (1 active)

US7846961 Expires Oct 5, 2029
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2029
  • • 9 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: NDA205003 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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