NDAINTRAVENOUSSOLUTION
Approved
Oct 2019
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
4/8 — Partial
BIORPHEN (phenylephrine hydrochloride) by Dr. Reddy's Laboratories is α-1 adrenergic receptor agonist. First approved in 2019.
Drug data last refreshed 4h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BIORPHEN is an intravenous solution of phenylephrine hydrochloride, an α-1 adrenergic receptor agonist approved in October 2019. It is used to treat hypotension in acute care settings by increasing peripheral vascular resistance and blood pressure. The drug is indicated for patients requiring rapid hemodynamic support in hospital or critical care environments.
Peak
Product is at peak lifecycle stage with low Part B ASP ($0.163), indicating mature market positioning with limited pricing power and likely stable but resource-constrained team investment.
Mechanism of Action
α-1 adrenergic receptor agonist.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu
Started Jul 2013
341 enrolled
Upper Respiratory Tract InfectionNasal CongestionRhinorrhea+1 more
Study to Find Out Whether Participants With a History of Stuffy Nose Due to Allergic Reactions in the Nose Would Intend to Buy Drug Phenylephrine Hydrochloride Extended Release Tablets After Receiving it Once in This Study
Started May 2012
347 enrolled
Nasal Congestion Due to Allergic Rhinitis
Safety of Phenylephrine Hydrochloride, Acetaminophen, Dimethindene Maleate Compared to Phenylephrine Hydrochloride Alone in Healthy Volunteers
Started Sep 2010
0Heart RateBlood PressureArrhythmias
Consumer Preference Study of Two Formulations of Phenylephrine Hydrochloride (Study CL2008-15)(P07530)(COMPLETED)
Started Aug 2009
331 enrolled
Vasomotor RhinitisSeasonal Allergic Rhinitis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.