TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

IMMPHENTIV

PHENYLEPHRINE HYDROCHLORIDE
Approved 2012-12-20
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
13
Years on Market

Details

Status
Prescription
First Approved
2012-12-20
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

Hikma
Active Ingredient: PHENYLEPHRINE HYDROCHLORIDE

IMMPHENTIV Approval History

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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 Competitors

Pro

7 other drugs also target alpha-1 adrenergic receptor. Compare mechanisms, indications, and trial activity.

CARVEDILOL
Aurobindo Pharma
SILODOSIN
CHARTWELL RX
PHENYLEPHRINE HYDROCHLORIDE
Hikma
RYZUMVI
FAMYGEN LIFE SCI
COREG
WAYLIS THERAP
COREG CR
WAYLIS THERAP
TONMYA
TONIX
Drug = Competitor name Company = Manufacturer N indic. = FDA-approved indications → Date = Patent/exclusivity expiry

Competitors share the same molecular target (alpha-1 adrenergic receptor). Earlier expiry dates signal biosimilar/generic opportunities.

Drugs Similar to IMMPHENTIV

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

PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDE
8 shared
GENUS
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:
Nasal CongestionCoughHeadache +2 more
ADVAIR DISKUS 100/50
FLUTICASONE PROPIONATE
3 shared
GSK
Shared indications:
Nasal CongestionRunny NoseSneezing
ADVAIR DISKUS 250/50
FLUTICASONE PROPIONATE
3 shared
GSK
Shared indications:
Nasal CongestionRunny NoseSneezing
ADVAIR DISKUS 500/50
FLUTICASONE PROPIONATE
3 shared
GSK
Shared indications:
Nasal CongestionRunny NoseSneezing
ASTEPRO
AZELASTINE HYDROCHRLORIDE
3 shared
MEDA PHARMS
Shared indications:
Nasal CongestionRunny NoseSneezing
BREZTRI AEROSPHERE
BUDESONIDE
3 shared
AstraZeneca
Shared indications:
Nasal CongestionRunny NoseSneezing
BUDESONIDE
BUDESONIDE
3 shared
Teva
Shared indications:
Nasal CongestionRunny NoseSneezing
ENTOCORT EC
BUDESONIDE
3 shared
PADAGIS US
Shared indications:
Nasal CongestionRunny NoseSneezing
FLOVENT DISKUS 100
FLUTICASONE PROPIONATE
3 shared
GSK
Shared indications:
Nasal CongestionRunny NoseSneezing
FLOVENT DISKUS 250
FLUTICASONE PROPIONATE
3 shared
GSK
Shared indications:
Nasal CongestionRunny NoseSneezing
FLOVENT DISKUS 50
FLUTICASONE PROPIONATE
3 shared
GSK
Shared indications:
Nasal CongestionRunny NoseSneezing
FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATE
3 shared
ENCUBE
Shared indications:
Nasal CongestionRunny NoseSneezing
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
FLUTICASONE PROPIONATE
3 shared
Teva
Shared indications:
Nasal CongestionRunny NoseSneezing
RHINOCORT
BUDESONIDE
3 shared
KENVUE BRANDS
Shared indications:
Nasal CongestionRunny NoseSneezing
SYMBICORT AEROSPHERE
BUDESONIDE
3 shared
AstraZeneca
Shared indications:
Nasal CongestionRunny NoseSneezing
ALLZITAL
ACETAMINOPHEN
2 shared
PHARMOBEDIENT
Shared indications:
HeadacheFever
ANAPROX DS
NAPROXEN SODIUM
2 shared
ATNAHS PHARMA US
Shared indications:
HeadacheFever
ANEXSIA 5/325
ACETAMINOPHEN
2 shared
SPECGX LLC
Shared indications:
HeadacheFever
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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.

IMMPHENTIV FDA Label Details

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Indications & Usage

FDA Label (PDF)

Uses temporarily relieves these common cold and flu symptoms: cough nasal congestion minor aches and pains sore throat headache runny nose sneezing temporarily reduces fever controls cough to help your child get to sleep

IMMPHENTIV Patents & Exclusivity

Latest Patent: Sep 2036

Patents (12 active)

US11213480 Expires Sep 26, 2036
US12257342 Expires Sep 26, 2036
US11471400 Expires Aug 5, 2036
+ 2 more patents
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA203826 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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