Twinject Patent Expiration

Twinject is a drug owned by Impax Laboratories Llc. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 04, 2025. Details of Twinject's patents and their expiration are given in the table below.

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Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7621891 Method and apparatus for delivering epinephrine
Feb, 2025

(1 year, 7 months ago)

Expired
US7297136 Medicine injection devices and methods
Jan, 2025

(1 year, 8 months ago)

Expired


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 Twinject's patents.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 18 Dec, 2020 US7621891
Payment of Maintenance Fee, 12th Year, Large Entity 17 May, 2019 US7297136
Entity Status Set To Undiscounted (Initial Default Setting or Status Change) 31 May, 2011 US7297136
Change in Power of Attorney (May Include Associate POA) 20 Apr, 2010 US7621891
Change in Power of Attorney (May Include Associate POA) 20 Apr, 2010 US7297136
Correspondence Address Change 16 Apr, 2010 US7297136
Correspondence Address Change 16 Apr, 2010 US7621891
Patent Issue Date Used in PTA Calculation 24 Nov, 2009 US7621891
Recordation of Patent Grant Mailed 24 Nov, 2009 US7621891
Issue Notification Mailed 04 Nov, 2009 US7621891

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US patents provide insights into the exclusivity only within the United States, but Twinject is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Twinject's family patents as well as insights into ongoing legal events on those patents.

Twinject's Family Patents

Twinject has patent protection in a total of 15 countries. It's US patent count contributes only to 34.0% of its total global patent coverage. 7 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Twinject.

Family Patents

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Clinical Trials

Recent Clinical Trials on Twinject:

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




Generic Launch

Generic Release Date:

Twinject's generic launch date based on the expiry of its last outstanding patent is estimated to be Feb 04, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Twinject Generic API suppliers:

Epinephrine is the generic name for the brand Twinject. 9 different companies have already filed for the generic of Twinject, with Gland having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Twinject's generic

Alternative Brands for Twinject

There are several other brand drugs using the same active ingredient (Epinephrine) as Twinject. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.


Apart from brand drugs containing the same ingredient, some generics have also been filed for Epinephrine, Twinject's active ingredient. Check the complete list of approved generic manufacturers for Twinject





About Twinject

Twinject is a drug owned by Impax Laboratories Llc. Twinject uses Epinephrine as an active ingredient. Twinject was launched by Impax in 2009.

Approval Date:

Twinject was approved by FDA for market use on 25 November, 2009.

Active Ingredient:

Twinject uses Epinephrine as the active ingredient. Check out other Drugs and Companies using Epinephrine ingredient

Dosage:

Twinject is available in injectable form for intramuscular, subcutaneous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 0.3MG/DELIVERY INJECTABLE Discontinued INTRAMUSCULAR, SUBCUTANEOUS
EQ 0.15MG/DELIVERY INJECTABLE Discontinued INTRAMUSCULAR, SUBCUTANEOUS