TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

AUVI-Q

EPINEPHRINE Adrenergic alpha-Agonists
Cardiovascular Approved 2012-08-10
2
Indications
--
Phase 3 Trials
1
Priority Reviews
13
Years on Market

Details

Status
Prescription
First Approved
2012-08-10
Routes
INTRAMUSCULAR, SUBCUTANEOUS
Dosage Forms
SOLUTION

Companies

Active Ingredient: EPINEPHRINE

AUVI-Q Approval History

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What AUVI-Q Treats

2 indications

AUVI-Q is approved for 2 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Anaphylaxis
  • Allergic Reaction
Source: FDA Label
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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.

AUVI-Q FDA Label Details

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Indications & Usage

FDA Label (PDF)

AUVI-Q® is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. AUVI-Q is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a histo...

AUVI-Q Patents & Exclusivity

Latest Patent: Dec 2037

Patents (72 active)

US10688244 Expires Dec 21, 2037
US10842938 Expires Dec 21, 2037
US11771830 Expires Dec 21, 2037
US8021344 Expires Nov 2, 2029
US8226610 Expires Apr 10, 2029
US8231573 Expires Nov 25, 2028
US7947017 Expires Mar 12, 2028
US8206360 Expires Feb 27, 2027
US11590286 Expires Dec 12, 2026
+ 62 more patents
Source: FDA Orange Book

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Data Sources

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