Epinephrine Patent Expiration

Epinephrine was first introduced by Sterling Health Div Sterling Winthrop Inc in its drug Bronkaid Mist on Approved Prior to Jan 1, 1982. Other drugs containing Epinephrine are Epi E Z Pen Jr, Epipen E Z Pen, Adrenaclick, Sus-Phrine Sulfite Free, Epipen Jr., Twinject, Adrenalin, Auvi-Q, Primatene Mist, Epipen, Neffy, Symjepi, Epinephrine. 21 different companies have introduced drugs containing Epinephrine.


Epinephrine Patents

Given below is the list of patents protecting Epinephrine, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Epinephrine US12539283 Jan 17, 2045 Fresenius Kabi Usa
Adrenalin US10653646 Epinephrine compositions and containers Mar 21, 2039 Ph Health
Adrenalin US11083698 Epinephrine compositions and containers Mar 21, 2039 Ph Health
Adrenalin US11207280 Epinephrine compositions and containers Mar 21, 2039 Ph Health
Adrenalin US12133837 Epinephrine compositions and containers Mar 21, 2039 Ph Health
Neffy US10682414 Intranasal epinephrine formulations and methods for the treatment of disease Feb 06, 2039 Ars Pharms Operation
Neffy US11191838 Intranasal epinephrine formulations and methods for the treatment of disease Feb 06, 2039 Ars Pharms Operation
Neffy US11717571 Intranasal epinephrine formulations and methods for the treatment of disease Feb 06, 2039 Ars Pharms Operation
Neffy US11744895 Intranasal epinephrine formulations and methods for the treatment of disease Feb 06, 2039 Ars Pharms Operation
Neffy US11918655 Intranasal epinephrine formulations and methods for the treatment of disease Feb 06, 2039 Ars Pharms Operation
Neffy US12324838 Intranasal epinephrine formulations and methods for the treatment of disease Feb 06, 2039 Ars Pharms Operation
Neffy US10576156 Compositions for drug administration Feb 06, 2038 Ars Pharms Operation
Neffy US11173209 Compositions for drug administration Feb 06, 2038 Ars Pharms Operation
Auvi-q US10688244 Medicament delivery device and methods for delivering drugs to infants and children Dec 21, 2037 Kaleo Inc
Auvi-q US10842938 Medicament delivery device and methods for delivering drugs to infants and children Dec 21, 2037 Kaleo Inc
Auvi-q US11771830 Medicament delivery device and methods for delivering drugs to infants and children Dec 21, 2037 Kaleo Inc
Symjepi US11141540 Syringe devices Oct 20, 2036 Adamis Pharms Corp
Adrenalin US10130592 Epinephrine formulations Mar 13, 2035 Ph Health
Adrenalin US12280024 Epinephrine formulations Mar 13, 2035 Ph Health
Adrenalin US9119876 Epinephrine formulations Mar 13, 2035 Ph Health
Adrenalin US9295657 Epinephrine formulations Mar 13, 2035 Ph Health
Epinephrine US9283197 More potent and less toxic formulations of epinephrine and methods of medical use Aug 15, 2034 Bpi Labs
Epinephrine US10004700 More potent and less toxic formulations of epinephrine and methods of medical use Aug 14, 2034 Bpi Labs
Epinephrine US10039728 More potent and less toxic formulations of epinephrine and methods of medical use Aug 14, 2034 Bpi Labs
Auvi-q US8021344 Medicament delivery device configured to produce an audible output Nov 02, 2029 Kaleo Inc
Auvi-q US8226610 Medical injector with compliance tracking and monitoring Apr 10, 2029 Kaleo Inc
Auvi-q US8231573 Medicament delivery device having an electronic circuit system Nov 25, 2028 Kaleo Inc
Auvi-q US7749194 Devices, systems, and methods for medicament delivery Oct 30, 2028 Kaleo Inc
Auvi-q US7947017 Devices, systems and methods for medicament delivery Mar 12, 2028 Kaleo Inc
Auvi-q US9724471 Devices, systems, and methods for medicament delivery May 23, 2027 Kaleo Inc
Adrenaclick US7905352 Kits containing medicine injection devices and containers Apr 12, 2027 Impax
Auvi-q US8206360 Devices, systems and methods for medicament delivery Feb 27, 2027 Kaleo Inc
Auvi-q US9238108 Medicament delivery device having an electronic circuit system Feb 20, 2027 Kaleo Inc
Auvi-q US11590286 Devices, systems and methods for medicament delivery Dec 12, 2026 Kaleo Inc
Auvi-q US10960155 Devices, systems and methods for medicament delivery Jun 25, 2026

(Expired)

Kaleo Inc
Auvi-q US7731686 Devices, systems and methods for medicament delivery Jun 01, 2026

(Expired)

Kaleo Inc
Auvi-q US8926594 Devices, systems and methods for medicament delivery Mar 31, 2026

(Expired)

Kaleo Inc
Auvi-q US9259539 Devices, systems and methods for medicament delivery Feb 01, 2026

(Expired)

Kaleo Inc
Auvi-q US9278182 Devices, systems and methods for medicament delivery Feb 01, 2026

(Expired)

Kaleo Inc
Primatene Mist US8367734 Stable epinephrine suspension formulation with high inhalation delivery efficiency Jan 26, 2026

(Expired)

Armstrong Pharms
Epipen US7449012 Automatic injector Sep 11, 2025

(Expired)

Viatris
Epipen US7794432 Automatic injector with kickback attenuation Sep 11, 2025

(Expired)

Viatris
Epipen US8048035 Automatic injector with needle cover Sep 11, 2025

(Expired)

Viatris
Epipen US8870827 Automatic injector Sep 11, 2025

(Expired)

Viatris
Epipen US9586010 Automatic injector with needle cover Sep 11, 2025

(Expired)

Viatris
Epipen Jr. US7449012 Automatic injector Sep 11, 2025

(Expired)

Viatris
Epipen Jr. US7794432 Automatic injector with kickback attenuation Sep 11, 2025

(Expired)

Viatris
Epipen Jr. US8048035 Automatic injector with needle cover Sep 11, 2025

(Expired)

Viatris
Epipen Jr. US8870827 Automatic injector Sep 11, 2025

(Expired)

Viatris
Epipen Jr. US9586010 Automatic injector with needle cover Sep 11, 2025

(Expired)

Viatris
Auvi-q US9149579 Devices, systems and methods for medicament delivery Jul 19, 2025

(Expired)

Kaleo Inc
Auvi-q US10335549 Devices, systems and methods for medicament delivery Apr 30, 2025

(Expired)

Kaleo Inc
Auvi-q US8016788 Devices, systems and methods for medicament delivery Mar 21, 2025

(Expired)

Kaleo Inc
Twinject US7621891 Method and apparatus for delivering epinephrine Feb 04, 2025

(Expired)

Impax
Adrenaclick US10166334 Medicine injection apparatuses Jan 21, 2025

(Expired)

Impax
Adrenaclick US10166344 Injection needle assembly Jan 21, 2025

(Expired)

Impax
Twinject US7297136 Medicine injection devices and methods Jan 18, 2025

(Expired)

Impax
Auvi-q US7731690 Devices, systems and methods for medicament delivery Jan 15, 2025

(Expired)

Kaleo Inc
Auvi-q US10314977 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Auvi-q US10737028 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Auvi-q US7918823 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Auvi-q US8313466 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Auvi-q US8361029 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Auvi-q US8425462 Devices, systems, and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Auvi-q US8608698 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Auvi-q US8920377 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Auvi-q US9056170 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Auvi-q US9737669 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Auvi-q US9833573 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Adrenaclick US5665071 Reloadable automatic or manual emergency injection system May 27, 2013

(Expired)

Impax



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Epinephrine's patents.

Given below is the list recent legal activities going on the following patents of Epinephrine.

Activity Date Patent Number
Patent litigations
Recordation of Patent Grant Mailed 10 Feb, 2026 US12539283
Mail Patent eGrant Notification 03 Feb, 2026 US12539283
Email Notification 03 Feb, 2026 US12539283
Recordation of Patent eGrant 03 Feb, 2026 US12539283
Patent Issue Date Used in PTA Calculation 03 Feb, 2026 US12539283
Patent eGrant Notification 03 Feb, 2026 US12539283
Email Notification 22 Jan, 2026 US12539283
Issue Notification Mailed 21 Jan, 2026 US12539283
Dispatch to FDC 12 Jan, 2026 US12539283
Email Notification 07 Jan, 2026 US12539283


Epinephrine's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Epinephrine:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants National Institute of Allergy and Infectious Diseases (NIAID) NA COMPLETED
(Sep 1, 2026)
PHASE3
Naloxone for Opioid Associated Out of Hospital Cardiac Arrest University of California, San Francisco NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2
An Outpatient Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria ARS Pharmaceuticals, Inc. NA RECRUITING
(Sep 1, 2026)
PHASE2
Combination Upper-Airway Electrical and Pharmacological Stimulation for Obstructive Sleep Apnea Brigham and Women's Hospital NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
Effects of Different Administration Routes of Dexmedetomidine on Postoperative Sleep Quality in Patients Undergoing Thyroidectomy The Second People's Hospital of Huai'an NA COMPLETED
(Sep 1, 2026)
PHASE1, PHASE2
Epicutaneous Immunotherapy in Peanut Allergy in Children Assistance Publique - Hôpitaux de Paris NA COMPLETED
(Aug 1, 2026)
PHASE2
CO2 Modulation in Endovascular Thrombectomy for Acute Ischemic Stroke University Hospital, Clermont-Ferrand NA RECRUITING
(Aug 1, 2026)
PHASE2
Tranexamic Acid in Nasal Mohs Reconstruction Vanderbilt University Medical Center NA RECRUITING
(Aug 1, 2026)
PHASE2
Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms Janssen Research & Development, LLC NA RECRUITING
(Aug 1, 2026)
PHASE3
Effects of Inhaled Epinephrine on Systemic Allergic Reactions During Allergy Testing, Immunotherapy or Oral Challenges Dr. George Luciuk NA RECRUITING
(Aug 1, 2026)
PHASE1
Pre-emptive Insulin to Prevent High Glucose After a Knee Steroid Injection in Adults With Type 2 Diabetes Shifa International Hospital NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
The Efficacy of a Pharmacological Treatment (Reboxetine Plus Ritalin) Versus Dog-Assisted Therapy in PTSD University of Haifa NA RECRUITING
(Aug 1, 2026)
PHASE2
A Study on the Application of NE Irrigation Fluid for Hemostasis in Flexible Ureteroscopic Lithotripsy: A Prospective Single-arm Interventional Study of Upper Urinary Tract Calculi.(NE: Norepinephrine) Geriatric Hospital of Nanjing Medical University NA RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Safety, Tolerability and Efficacy of Nefopam Cream in Burn Patients University of Alberta NA COMPLETED
(Jul 1, 2026)
PHASE2
Epinephrine in the Pediatric Intensive Care Unit: A Dose-Effect Trial Boston Children's Hospital NA TERMINATED
(Jul 1, 2026)
PHASE2
Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol Axsome Therapeutics, Inc. NA RECRUITING
(Jul 1, 2026)
PHASE3
Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN) Axsome Therapeutics, Inc. NA RECRUITING
(Jul 1, 2026)
PHASE3
Role of Folic Acid in the Management of Adjuvant Endocrine Therapy-Induced Hot Flashes in Breast Cancer Patients Future University in Egypt NA COMPLETED
(Jul 1, 2026)
PHASE3
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of DESF in Pediatric Subjects Aquestive Therapeutics NA COMPLETED
(Jul 1, 2026)
PHASE1
Intra-Prostatic Epinephrine Injection in Bipolar Transurethral Resection of Large Prostate: Exploring Its Role in Optimizing Surgical Outcomes Benha University NA RECRUITING
(Jul 1, 2026)
PHASE3
Effects of Mirtazapine on Appetite in Advanced Cancer Patients M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
Nicotinamide Riboside Supplementation for Treating Arterial Stiffness and Elevated Systolic Blood Pressure in Patients With Moderate to Severe CKD University of Colorado, Denver NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
Duloxetine and Neurofeedback Training for the Treatment of Chemotherapy Induced Peripheral Neuropathy M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
Twin Block, Pain Medications and Third Molar Extractions Rutgers, The State University of New Jersey NA RECRUITING
(Jun 1, 2026)
PHASE2
A Study to Test How Well Different Doses of BI 1569912 Are Tolerated and How Well They Work in People With Depression Who Take Anti-depressive Medication Boehringer Ingelheim NA COMPLETED
(Jun 1, 2026)
PHASE1
Effect of Preoperative Tramadol and Naproxen Sodium on Post Operative Pain Dow University of Health Sciences NA COMPLETED
(Jun 1, 2026)
PHASE2, PHASE3
REctus Sheath Trial Duke University NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE2
18F-mFBG Cardiac Uptake With Lewy Body Dementia Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) NA RECRUITING
(Jun 1, 2026)
PHASE2
Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury University of Manitoba NA RECRUITING
(May 1, 2026)
PHASE1
A Trial of Vitamin B12 in Septic Shock Medical College of Wisconsin NA COMPLETED
(May 1, 2026)
PHASE2
Role of Pharmacotherapy in Counteracting Weight Regain in Adolescents With Severe Obesity University of Minnesota NA COMPLETED
(May 1, 2026)
PHASE2
A Study of Aticaprant Plus an Antidepressant to Prevent Return of Depression Symptoms in Participants With Major Depressive Disorder Who Experience a Loss of Interest and Pleasure Janssen Research & Development, LLC NA TERMINATED
(May 1, 2026)
PHASE3
PK/PD Study of IN-001 Sublingual Spray in Healthy Adults Insignis Therapeutics, Inc. NA COMPLETED
(May 1, 2026)
PHASE1
Corticosteroids in Hyperinflammatory Phenotype of Critical Illness Bin Du NA RECRUITING
(May 1, 2026)
PHASE2
Beta-Blockers on the Efficacy of Neoadjuvant Immunotherapy for Gastric Cancer Nanfang Hospital, Southern Medical University NA NOT YET RECRUITING
(May 1, 2026)
PHASE2
Melissa Officinalis Aromatherapy for Dental Anxiety in Children Universidad Autonoma de San Luis Potosí NA NOT YET RECRUITING
(May 1, 2026)
PHASE2
Effect of Remimazolam Sedation on Outcomes of Mechanically Ventilated Patients in the ICU Southeast University, China NA RECRUITING
(May 1, 2026)
PHASE3
Feasibility and Safety of Targeting Neutral vs Liberal Fluid Balance in Traumatic Brain Injured Patients- LIMIT-TBI Trial Erasme University Hospital NA RECRUITING
(May 1, 2026)
PHASE2
Mechanisms of Hypoglycemia Associated Autonomic Failure Albert Einstein College of Medicine NA TERMINATED
(Apr 1, 2026)
PHASE2
Role of Microglial Activation and Norepinephrine Transporter Abnormalities in Pathogenesis of MS-related Fatigue Brigham and Women's Hospital NA COMPLETED
(Apr 1, 2026)
PHASE1, PHASE2
A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant and Long-term Safety Extension Treatment With Seltorexant Janssen Research & Development, LLC NA COMPLETED
(Apr 1, 2026)
PHASE3
Prevention of Atrial Fibrillation by Low-dose Landiolol Administration After Cardiac Surgery CMC Ambroise Paré NA COMPLETED
(Apr 1, 2026)
PHASE3
A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD) Janssen Research & Development, LLC NA TERMINATED
(Apr 1, 2026)
PHASE3
Vasopressin vs. Epinephrine During Neonatal Cardiopulmonary Resuscitation University of Alberta NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1
Can PLIA Reduce Early Post-operative Pain After PAO Surgery? Michael C Willey NA RECRUITING
(Apr 1, 2026)
PHASE2, PHASE3
Lipomas Treated With Subcutaneous Injections of Cooled or Warmed Sodium Chloride West Virginia University NA RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Efficacy of Early Argipressin in the Management of Intensive Care Patients With Norepinephrine-refractory Vasoplegic Shock Centre Hospitalier Universitaire Dijon NA RECRUITING
(Apr 1, 2026)
PHASE3
Exploring Sympathetic Nervous System Function in Individuals With Down Syndrome University of Colorado, Denver NA RECRUITING
(Apr 1, 2026)
PHASE3
Resuscitation Enhancement to Avoid Rearrest Through Evidence-based Strategies in Prehospital Post-resuscitation Care Siriraj Hospital NA RECRUITING
(Apr 1, 2026)
PHASE2, PHASE3
Efficacy of the Alpha 2 Agonist Dexmedetomidine for Sympathetic Deactivation in REfractory Septic Shock Hospices Civils de Lyon NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE3
Angiotensin II in Liver Transplantation University of California, San Francisco NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE2, PHASE3
Effect of Adding a Low-Dose Epinephrine Bolus Prior to Infusion on Maternal Hemodynamic Stability During Cesarean Section Cairo University NA COMPLETED
(Mar 1, 2026)
PHASE3
Venlafaxine as Adjunct Therapy in Rheumatoid Arthritis Ain Shams University NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE2


Epinephrine Generic API Manufacturers

Several generic applications have been filed for Epinephrine. The first generic version for Epinephrine was by Armstrong Pharmaceuticals Inc and was approved on May 23, 1984. And the latest generic version is by Deva Holding Anonim Sirketi and was approved on Jul 31, 2026.

Given below is the list of companies who have filed for Epinephrine generic, along with the locations of their manufacturing plants worldwide.