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Details for Generic Name: epinephrine

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Epinephrine is the generic ingredient in thirty-one branded drugs marketed by Sterling, Armstrong Pharms, Wyeth Cons, Forest Labs, Mylan Speclt, Par Sterile Products, Amedra Pharms, Sanofi Aventis Us, 3M, Astrazeneca, Dentsply Pharm, Deproco, Septodont Inc, Belcher Pharms Llc, Carlisle, Eastman Kodak, Eurohlth Intl Sarl, Graham Chem, Hospira, Abbott, Bel Mar, Dell Labs, Intl Medication, Watson Labs, Pharmaton, Septodont, Fresenius Kabi Usa, Vyteris, Iomed, and Empi, and is included in fifty-one NDAs. There are twenty-seven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and fifty-six patent family members in twenty-three countries.

There are sixteen drug master file entries for epinephrine. Twelve suppliers are listed for this compound.

Summary for Generic Name: epinephrine

Drug Master File Entries: see list16
Suppliers / Packaging: see list33
Therapeutic Class:Respiratory Tract Agents

Pharmacology for Ingredient: epinephrine

Clinical Trials for: epinephrine

A Study for Absorption of Intranasal Epinephrine Compared to Conventional Intramuscular Epinephrine
Status: Completed Condition: Anaphylaxis

Epinephrine Inhalation Aerosol USP, a HFA-MDI Study for Assessment of Pharmacokinetics
Status: Completed Condition: Asthma; Bronchospasm; Wheezing; Shortness of Breath

Pharmacokinetics (PK) Study of Epinephrine Inhalation Aerosol in Healthy Volunteers
Status: Completed Condition: Asthma

Make up for the Epinephrine Autoinjector
Status: Completed Condition: Anaphylaxis

The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine
Status: Completed Condition: Spinal Anesthesia

Does the Addition of Epinephrine Prolong the Duration of Spinal Anesthesia for Repeat Cesarean Section?
Status: Recruiting Condition: Spinal Anesthesia; Cesarean Section

The Effect and Safety of Low Dose Nebulized Epinephrine in Croup
Status: Not yet recruiting Condition: Croup; Epinephrine Neublizer Treatment

Trial of Vasopressin and Epinephrine to Epinephrine Only for In-Hospital Pediatric Cardiopulmonary Resuscitation
Status: Recruiting Condition: Cardiopulmonary Arrest; Cardiac Arrest

ED50 and ED95 of Intrathecal Bupivacaine With or Without Epinephrine for Total Knee Replacement Arthroplasty
Status: Completed Condition: Spinal Anesthesia; Total Knee Replacement Arthroplasty

Low-dose Epinephrine Infusion Tests in Adolescent and Pediatric Patients
Status: Terminated Condition: Congenital Disorders

Efficacy of Ropivacaine (With Epinephrine) in BABA Endoscopic and Robotic Thyroidectomy
Status: Recruiting Condition: Thyroid Neoplasm; Goiter

Post-Caesarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine
Status: Completed Condition: Pain, Postoperative

Comparative Study of Autologous Blood Injection Versus Diluted Epinephrine in Treating Actively Bleeding Gastroduodenal Ulcers
Status: Completed Condition: Blood, Injection, Injury Type Phobia; Gastrointestinal Ulcer Haemorrhage; Adverse Reaction to Epinephrine

Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext
Status: Completed Condition: Handling of Auto-injectors

Adrenal Scans With Radioiodine-Labeled Norcholesterol (NP-59)
Status: Completed Condition: Adrenal Tumors; Adrenal Malignancies; Abnormal Hormonal Secretions; Electrolytes Abnormalities

Epinephrine Inhalation Aerosol USP: For Evaluation Of Efficacy And Safety In Asthma Patients
Status: Completed Condition: Asthma

Intranasal Injection Versus Topical Administration of Epinephrin During Endoscopic Sinus Surgery
Status: Not yet recruiting Condition: Hypertension; Hypotension; Tachycardia; Bradycardia; Arrhythmia

Effect of Epinephrine on Systemic Absorption of Mepivacaine in Uremic Patients
Status: Terminated Condition: Renal Insufficiency, Chronic

Effects of Epinephrine and Intravenous (I.V.) Needle on Cardiopulmonary Resuscitation (CPR) Outcome
Status: Completed Condition: Cardiac Arrest

Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation
Status: Recruiting Condition: Asthma

Gluing Lacerations Utilizing Epinephrine
Status: Completed Condition: Lacerations

Combined Vasopressin, Methylprednisolone, and Epinephrine for Inhospital Cardiac Arrest
Status: Completed Condition: Heart Arrest

Assessment and Evaluation of Pharmacokinetic Profile of E004 in Healthy Adults
Status: Terminated Condition: Asthma

Self-injection and Self-management
Status: Recruiting Condition: Food Allergy

Anesthesia With Epinephrine in Diabetes Patients is Safe and Effective
Status: Completed Condition: Type 2 Diabetes Mellitus; Coronary Disease

Local Effects of Epinephrine on Lactate, Glucose, Lipid and Protein Metabolism in Bilaterally Perfused Human Legs
Status: Completed Condition: Healthy

Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation
Status: Completed Condition: Adrenal Tumors

Lidocaine With Epinephrine vs. Bupivacaine With Epinephrine as Local Anesthetic Agents in Wide-awake Hand Surgery
Status: Recruiting Condition: Carpal Tunnel Syndrome

Epinephrine, Dexamethasone and Hypertonic Saline in Bronchiolitis
Status: Not yet recruiting Condition: Bronchiolitis

The Effects of Epinephrine in Endotoxemia in Normal Volunteers
Status: Completed Condition: Immune System

Epinephrine, Dexamethasone, and Hypertonic Saline in Bronchiolitis, Randomised Clinical Trial of Efficacy and Safety
Status: Completed Condition: Bronchiolitis

Study Comparing the Efficacy and Tolerability of Epinephrine and Norepinephrine in Cardiogenic Shock
Status: Recruiting Condition: Cardiogenic Shock

Study Comparing Peri-articular Injection of Bupivacaine With and Without Epinephrine
Status: Terminated Condition: Osteoarthritis

Vasopressin, Epinephrine, and Steroids for Cardiac Arrest
Status: Completed Condition: Cardiac Arrest

Hemodynamic Stability of Bupivacaine With and Without Adrenaline for Paracervical Block for Cervical Conization
Status: Recruiting Condition: Cervical Intraepithelial Neoplasia

Effect of Dexamethasone and Epinephrine on the Duration of Sciatic Nerve Blocks With Ropivacaine
Status: Recruiting Condition: Postoperative Pain

Diagnosis of Central Adrenal Insufficiency in Patients With Prader-Willi Syndrome
Status: Recruiting Condition: Prader Willi Syndrome; Adrenal Insufficiency

Visualization in Shoulder Arthroscopy With and Without Epinephrine
Status: Completed Condition: Visualization in Shoulder Arthroscopy

Randomized, Placebo/Active Crossover Dose-ranging Study for Safety and Efficacy in Asthma Patients.
Status: Terminated Condition: Asthma

Test Predicting Adrenal Insufficiency in Volunteers Under Prednisone Treatment
Status: Completed Condition: Adrenal Gland Hypofunction

Adrenal Suppression and Adrenal Recovery Induced by Megestrol Acetate
Status: Completed Condition: Adrenal Insufficiency

Safety and Efficacy Study of an Iontophoretic Patch Containing Lidocaine and Epinephrine for Venipuncture in Healthy Adult Volunteers
Status: Completed Condition: Local Anesthesia

Effect of Epinephrine/ Phenylephrine for Preventing the Postreperfusion Syndrome During Reperfusion in Liver Transplantation
Status: Completed Condition: Hypotension After Reperfusion in Liver Transplantation

Vasopressin Versus Epinephrine in Myomectomy
Status: Completed Condition: Uterine Myomas

Comparing Vasopressin and Adrenaline in Patients With Cardiac Arrest
Status: Completed Condition: Cardiac Arrest

Use of Local Analgesia With Epinephrine During Total Hip Arthroplasty (THA)
Status: Completed Condition: Arthroplasty, Replacement, Hip

The Influence of Inhaled Adrenalin Versus Decongestant as a Local Nasal Treatment in Bronchiolitis
Status: Completed Condition: Bronchiolitis

Cardiovascular Risk in Patients With Non-Functional Adrenal Incidentaloma
Status: Completed Condition: Adrenal Cortex Neoplasms

SPARTACUS: Subtyping Primary Aldosteronism: a Randomized Trial Comparing Adrenal Vein Sampling and Computed Tomography Scan.
Status: Completed Condition: Hyperaldosteronism

Norepinephrine Plus Dobutamine Versus Epinephrine Alone for the Management of Septic Shock
Status: Completed Condition: Septic Shock; Severe Sepsis; Infections

Adrenal Venous Sampling in Patients With Overt or Subclinical Cushings Syndrome, and Bilateral Adrenal Tumors
Status: Recruiting Condition: Cushing Syndrome

Efficacy of Nebulised Hypertonic Saline (3%) Among Children With Bronchiolitis.
Status: Completed Condition: Bronchiolitis

Vasopressin and Epinephrine Versus Epinephrine Alone in Cardiac Arrest
Status: Completed Condition: Cardiac Arrest

Trial of Epinephrine and Albuterol in Bronchiolitis
Status: Active, not recruiting Condition: Bronchiolitis

Influence of Synacthen Infusion on the Results of Adrenal Venous Sampling in Patient With Primary Aldosteronism
Status: Recruiting Condition: Primary Aldosteronism

Plasma Concentrations of Levobupivacaine With and Without Epinephrine in Transversus Abdominis Plane Blocks
Status: Completed Condition: Transversus Abdominis Plane Block

Combined FDG-PET and 123I-Iodometomidate Imaging for Adrenal Neoplasia
Status: Not yet recruiting Condition: Adrenal Gland Neoplasms

Study of Intracameral Adrenaline for Pupil Dilation Without Topical Mydriatics in Refractive Cataract Surgery
Status: Completed Condition: Cataract

Surgery of Subclinical Cortisol Secreting Adrenal Incidentalomas
Status: Recruiting Condition: Adrenal Incidentalomas

Comparison of Perfusion Index, T Wave Amplitude, Systolic Blood Pressure and Heart Rate
Status: Recruiting Condition: Injections, Intravenous

Comparison of Epinephrine-lidocaine Solution and Dexmedetomidine -Lidocaine Solution
Status: Completed Condition: Craniotomy

A Randomized Trial of Rectal Indomethacin and Papillary Spray of Epinephrine Versus Rectal Indomethacin to Prevent Post-ERCP Pancreatitis in High Risk Patients
Status: Recruiting Condition: Post-ERCP Acute Pancreatitis

Hydrocortisone Versus Hydrocortisone Plus Fludrocortisone for the Treatment of Adrenal Insufficiency in Severe Sepsis
Status: Withdrawn Condition: Sepsis; Adrenal Insufficiency

Encouraging Allergic Young Adults to Carry Epinephrine
Status: Completed Condition: Adherence; Food Allergy

Comparison Between Epinephrine and Exercise Test in QT Long Syndrome Patients
Status: Recruiting Condition: Long QT Syndrome Type 1 or 2

Bupivacaine Injections Into Uterosacral Ligaments During Robotic Assisted Total Hysterectomies
Status: Not yet recruiting Condition: Pain

Comparison of Preincisional Infiltrated Dexmedetomidine and Lidocaine Plus Adrenaline for Nasal Sephoplasty Surgery.
Status: Completed Condition: Surgery; Pain

Status: Completed Condition: Asthma

Performance of 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in the Diagnosis of Indeterminate Adrenal Tumors on Conventional Imaging: A French Prospective Multicentric Study
Status: Active, not recruiting Condition: Adrenal Tumors

The RESTORE-SIRIO Randomized Controlled Trial
Status: Not yet recruiting Condition: Percutaneous Coronary Intervention; No-reflow Phenomen; Acute ST-segment Elevation Myocardial Infarction

Adrenal Insufficiency in Septic Shock
Status: Terminated Condition: Septic Shock; Acute Adrenal Insufficiency

Safety of Epidural Fentanyl and Adrenalin During Childbirth
Status: Recruiting Condition: Pregnancy; Pain

Acoustic Assessment of Nebulized Epinephrine Versus Albuterol for RSV Bronchiolitis- a Double Blind Study
Status: Terminated Condition: Rsv Bronchiolitis

Comparison of Topical Vasoconstriction in Endoscopic Sinus Surgery
Status: Recruiting Condition: Chronic Sinusitis

Effect of Sufentanil on the Rate of Anesthesia
Status: Completed Condition: Irreversible Pulpitis

The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery
Status: Not yet recruiting Condition: Chronic Sinusitis

Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q4
Status: Withdrawn Condition: Type 1 Diabetes

Evaluation of Molecular Markers in Adrenal Tumors
Status: Recruiting Condition: Adrenal Gland Neoplasms

Lipid-poor Adrenal Masses: Evaluation With Chemical Shift MRI
Status: Completed Condition: Adrenal Gland Disease

Evaluation of the Duration of Bupivacaine Spinal Block in Orthopedic Procedures With and Without Epinephrine Wash
Status: Recruiting Condition: Arthropathy of Hip; Arthropathy of Knee

Dental Anesthesia in Pregnant Women With Rheumatic Heart Disease
Status: Completed Condition: Rheumatic Heart Disease; Pregnancy; Dental Caries

Sensitivity of ECG on Detection of Three Different Intravascular Applied Test Doses of Bupivacaine and Epinephrine
Status: Completed Condition: Anaesthesia; Toxicity

High Flow Therapy vs Hypertonic Saline in Bronchiolitis
Status: Completed Condition: Acute Viral Bronchiolitis

Comparison of Cortisol Pump With Standard Treatment for Congenital Adrenal Hyperplasia
Status: Active, not recruiting Condition: Adrenal Insufficiency; Excess Androgen; Congenital Adrenal Hyperplasia (CAH)

Analgesic Duration of Long Acting Local Anesthetics for Low Volume Ultrasound-guided Interscalene Brachial Plexus Block
Status: Not yet recruiting Condition: Brachial Plexus Block; Anesthetics, Local

Protracted Mixture of Local Anesthetics for Major Foot and Ankle Surgery
Status: Recruiting Condition: Postoperative Pain

A European Post-Authorisation Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency
Status: Recruiting Condition: Chronic Adrenal Insufficiency

The Effect of Administration of Low Dose Adrenaline During Surgery on Bleeding During Hip Surgery
Status: Completed Condition: Intraoperative Blood Loss

Adrenal Vein Sampling International Study (AVIS Study)
Status: Completed Condition: Hyperaldosteronism

Optimal Time Delay of Epinephrine Injection With "One-per-mil" Tumescent Solution
Status: Enrolling by invitation Condition: Ischemia

Dopexamine and Norepinephrine Compared With Epinephrine Alone in Septic Shock
Status: Completed Condition: Septic Shock

Adrenal Insufficiency in Critical Emergencies in Digestive Diseases
Status: Recruiting Condition: Digestive Diseases; Adrenal Insufficiency; Gastrointestinal Bleeding; Variceal Bleeding; Acute Pancreatitis

Pilot Study to Characterize and Examine the Pharmacokinetics and Efficacy of Chronocort® in Adults With CAH
Status: Completed Condition: Endocrine Disease; Adrenal Insufficiency; Congenital Adrenal Hyperplasia

Vasoactive Drugs in Intensive Care Unit
Status: Recruiting Condition: Shock

Adrenal Tumors - Pathogenesis and Therapy
Status: Recruiting Condition: Adrenal Tumors; Adrenocortical Carcinoma; Cushing Syndrome; Conn Syndrome; Pheochromocytoma

Nebulized Adrenalin and Oral Betamethasone in Children With Bronchiolitis Attending Pediatric Emergencies.
Status: Recruiting Condition: Children; Bronchiolitis

Study of UK Adults With Congenital Adrenal Hyperplasia.
Status: Completed Condition: Congenital Adrenal Hyperplasia

Effectiveness Study of Different Local Anesthetic Mixtures
Status: Completed Condition: Pain

A Comparison of Tumescence in Breast Reduction Surgery
Status: Active, not recruiting Condition: Pain, Postoperative; Postoperative Nausea and Vomiting

Adrenal Function in Critical Illness
Status: Completed Condition: Adrenal Insufficiency

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS201739-001Aug 10, 2012RXNo8,231,573<disabled>Y <disabled>
epinephrine; lidocaine hydrochloride
PATCH;IONTOPHORESIS, TOPICAL021504-001May 6, 2004DISCNNo6,635,045<disabled>YY <disabled>
epinephrine; lidocaine hydrochloride
SOLUTION;IONTOPHORESIS, TOPICAL021486-001Oct 26, 2004DISCNNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: epinephrine

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Amedra Pharms
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS020800-003Nov 25, 20095,665,071<disabled>
Amedra Pharms
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS020800-004Nov 25, 20095,665,071<disabled>
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International Patent Family for Ingredient: epinephrine

Country Document Number Publication Date
Canada2762072Aug 10, 2006
United Kingdom2434548Apr 08, 2009
Australia2012201481Jan 07, 2016
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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