TheraRadar
Data updated: May 26, 2026

IMMPHENTIV (phenylephrine hydrochloride)

Pain Approved 2012-12-20

IMMPHENTIV is indicated for the treatment of Cough; Nasal Congestion; Pain; Sore Throat; Headache; Runny Nose; Sneezing; Fever.

Source: FDA Label • Hikma
1
Indication
--
Phase 3 Trials
13
Years on Market

Details

Status
Prescription
First Approved
2012-12-20
Patent Cliff
2036

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Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

Active Ingredient: PHENYLEPHRINE HYDROCHLORIDE

IMMPHENTIV Approval History

2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
16 FDA actions from 2012 to 2023
Mar 2023 SUPPL
Label · Labeling
Jun 2019 SUPPL
Mfg · Manufacturing (CMC)
Dec 2016 SUPPL
Mfg · Manufacturing (CMC)

What IMMPHENTIV Treats

8 indications

IMMPHENTIV is approved for 8 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Cough
  • Nasal Congestion
  • Pain
  • Sore Throat
  • Headache
  • Runny Nose
  • Sneezing
  • Fever
Source: FDA Label

IMMPHENTIV Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

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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.

Drugs Similar to IMMPHENTIV

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDE
8 shared
Hikma
Shared indications:
CoughNasal CongestionPain +5 more
PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
PHENYLEPHRINE HYDROCHLORIDE
8 shared
Dr. Reddy's
Shared indications:
CoughNasal CongestionPain +5 more
PROMETHAZINE W/ DEXTROMETHORPHAN
DEXTROMETHORPHAN HYDROBROMIDE
5 shared
PHARMOBEDIENT
Shared indications:
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Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT05997732 STARS Pro00126600 Ph 4 recruiting Sympathetic Neurovascular Transduction: Role of Adrenergic Receptors and Sex Differences
NCT03098680 PRIME PRIME (A094136) Ph 1 terminated A Study of the Pharmacokinetic and Pharmacodynamic Responses in Healthy and Altered Human Cardiovascular Systems
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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

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.

IMMPHENTIV FDA Label Details

Indications & Usage

FDA Label (PDF)

IMMPHENTIV is indicated for the treatment of Cough; Nasal Congestion; Pain; Sore Throat; Headache; Runny Nose; Sneezing; Fever.

View full patent landscape →
3 OB patents · 1 families · 6 international docs across 1 countries

IMMPHENTIV Patents & Exclusivity

Latest Patent: Sep 2036

Patents (3 active)

US11213480 Expires Sep 26, 2036
US12257342 Expires Sep 26, 2036
US11471400 Expires Aug 5, 2036
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for IMMPHENTIV

Revenue Insights

  • Quarterly revenue tracking
  • Historical trend analysis

Patent Timeline

  • Cliff: 2036
  • 12 active patents

Trial Analysis

  • Clinical trial tracking
  • Development stage analysis

Competitive Landscape

  • 20 similar drugs
  • 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.