NDAINTRAMUSCULARINJECTABLE1 Generic Approved
Approved
Dec 1987
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
20
Data completeness
5/8 — Partial
EPI E Z PEN JR (epinephrine) by Viatris is adrenergic alpha-agonists [moa]. Approved for alpha-adrenergic agonist [epc]. First approved in 1987.
Drug data last refreshed 7h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EPI E Z PEN JR is an intramuscular injectable epinephrine auto-injector approved in 1987 for pediatric emergency treatment of anaphylaxis and severe allergic reactions. It works as an alpha-adrenergic agonist, rapidly stimulating sympathetic nervous system receptors to reverse life-threatening allergic symptoms. This junior-dosed formulation is designed for children and smaller patients requiring lower epinephrine doses than adult versions.
LOE Approaching
With LOE approaching and moderate competitive pressure (45/100), expect consolidation of brand team focus toward generic transition and portfolio optimization rather than growth initiatives.
Mechanism of Action
Adrenergic alpha-Agonists
Pharmacologic Class:
alpha-Adrenergic Agonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Pharmacokinetics and Safety of a Single Dose of Epinephrine Nasal Spray in Paediatric Allergy Patients
Started Sep 2026
44 enrolled
EpinephrineHypersensitivity, ImmediateAnaphylaxis
Continuous Versus Bolus Norepinephrine Administration to Treat Postinduction Hypotension
Started May 2026
446 enrolled
Postinduction Hypotension
Study Comparing Glycerin With 1% Lidocaine and Epinephrine Versus Glycerin With 1% Lidocaine Without Epinephrine for the Sclerotherapy of Leg Telangiectasias
Started Feb 2026
20 enrolled
Leg Veins
Hemodynamic Effects of Norepinephrine Reduction on Critical Closing Pressure in Distributive Shock
Started Sep 2025
30 enrolled
Distributive ShockHemodynamic AssessmentCritical Illness
Pneumatic Leg Compression and Norepinephrine Requirements in Patients Having Non-cardiac Surgery
Started May 2025
238 enrolled
Hypotension During Surgery
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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.