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Data updated: May 26, 2026

ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER (esmolol hydrochloride)

Cardiovascular Approved 2016-04-07

Esmolol hydrochloride is a short-acting medication used for the rapid control of heart rate in patients experiencing atrial fibrillation or atrial flutter. It also helps patients with noncompensatory sinus tachycardia when a physician determines the heart rate needs specific intervention. Additionally, it treats high blood pressure and rapid heart rate that can occur during or immediately after surgery, such as during intubation or while waking up from anesthesia.

Source: FDA Label • HQ SPCLT PHARMA

How ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER Works

This drug works by blocking beta 1 receptors located primarily in the heart muscle. By inhibiting these receptors, it slows the heart rate and lowers blood pressure with a very fast onset and a short duration of action. While it mainly targets the heart, higher doses can also affect receptors in the lungs and blood vessels.

1
Indication
--
Phase 3 Trials
10
Years on Market

Details

Status
Prescription
First Approved
2016-04-07
Patent Cliff
2033

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Active Ingredient: ESMOLOL HYDROCHLORIDE

ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER Approval History

2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2016 to 2024
May 2024 SUPPL
Label · Labeling
Apr 2016 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer

What ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER Treats

6 indications

ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER is approved for 6 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Supraventricular Tachycardia
  • Atrial Fibrillation
  • Atrial Flutter
  • Sinus Tachycardia
  • Tachycardia
  • Hypertension
Source: FDA Label

ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Clinical Trial Registry

5 trials
Trial Sponsor ID Phase Status Title
NCT06291363 ESMONOL 2024-3612 Ph 4 recruiting Impact of Administration of Esmolol on Nociception Level-guided Control of Nociception.
NCT01113515 results posted Novalead-Galnobax-0210 Ph 1, Ph 2 completed Clinical Investigation of Galnobax® for the Treatment of Diabetic Foot Ulcers
NCT03998436 results posted NG-A16 Ph 3 completed Phase 3 Study to Evaluate the Safety and Efficacy of Galnobax® in Treating Diabetic Foot Ulcers
NCT02967029 IstanbulUn Ph 4 completed Effect of Controlled Hypotension on Cerebral Oxygen Saturation
NCT01652898 AOP LDLA202.101 Ph 1 completed A Pharmacokinetic, Pharmacodynamic, Safety Study With AOP LDLA202, ONO LDL50 and Esmolol in Healthy Volunteers
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Trial Timeline

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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.

ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER FDA Label Details

Indications & Usage

FDA Label (PDF)

ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER is indicated for the treatment of Supraventricular Tachycardia; Atrial Fibrillation; Atrial Flutter; Sinus Tachycardia; Tachycardia; Hypertension.

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2 OB patents · 1 families · 13 international docs across 8 countries

ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER Patents & Exclusivity

Latest Patent: Mar 2033

Patents (2 active)

US8829054 Expires Mar 15, 2033
US8835505 Expires Mar 15, 2033
Source: FDA Orange Book

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  • Cliff: 2033
  • 4 active patents

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Data Sources

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