lidocaine
Trade name: xylocaine
Approved
Nov 19, 1948
Lidocaine is a local anesthetic and cardiac depressant used to numb tissue in a specific area and for management of cardiac arrhythmias, particularly those of ventricular origins, such as occur with acute myocardial infarction. Lidocaine alters signal conduction in neurons by blocking the fast voltage-gated Na+ channels in the neuronal cell membrane responsible for signal propagation. With sufficient blockage, the membrane of the postsynaptic neuron will not depolarize and will thus fail to transmit an action potential. This creates the anesthetic effect by not merely preventing pain signals from propagating to the brain, but by stopping them before they begin. Careful titration allows for a high degree of selectivity in the blockage of sensory neurons, whereas higher concentrations also affect other modalities of neuron signaling. Lidocaine exerts an antiarrhythmic effect by increasing the electrical stimulation threshold of the ventricle during diastole. In usual therapeutic doses, lidocaine hydrochloride produces no change in myocardial contractility, in systemic arterial pressure, or an absolute refractory period. The efficacy profile of lidocaine as a local anesthetic is characterized by a rapid onset of action and intermediate duration of efficacy. Therefore, lidocaine is suitable for infiltration, block, and surface anesthesia. Longer-acting substances such as bupivacaine are sometimes given preference for spinal and epidural anesthesias; lidocaine, though, has the advantage of a rapid onset of action. Lidocaine is also the most important class-1b antiarrhythmic drug; it is used intravenously for the treatment of ventricular arrhythmias (for acute myocardial infarction, digoxin poisoning, cardioversion, or cardiac catheterization) if amiodarone is not available or contraindicated. Lidocaine should be given for this indication after defibrillation, CPR, and vasopressors have been initiated. A routine preventative dose is no longer recommended after a myocardial infarction as the overall benefit is not convincing. Inhaled lidocaine can be used as a cough suppressor acting peripherally to reduce the cough reflex. This application can be implemented as a safety and comfort measure for patients who have to be intubated, as it reduces the incidence of coughing and any tracheal damage it might cause when emerging from anesthesia. Adverse drug reactions (ADRs) are rare when lidocaine is used as a local anesthetic and is administered correctly. Most ADRs associated with lidocaine for anesthesia relate to administration technique (resulting in systemic exposure) or pharmacological effects of anesthesia, and allergic reactions only rarely occur. Systemic exposure to excessive quantities of lidocaine mainly result in a central nervous system (CNS) and cardiovascular effects – CNS effects usually occur at lower blood plasma concentrations and additional cardiovascular effects present at higher concentrations, though cardiovascular collapse may also occur with low concentrations. — NCATS
Clinical trial activity
1,854 trials · 935 clinical orgs · 104 marketing orgs
Earliest trial started Jan 1, 1996 (NCT00152724)
Timeline
1940s
- Nov 19, 1948
Earliest FDA Approval
- Nov 19, 1948
Dentsply International — NDA Secondary Org
- Nov 19, 1948
Fresenius — NDA Secondary Org
1950s
- May 17, 1951
AstraZeneca — NDA Secondary Org
- Mar 12, 1953
Akorn, Inc. — Marketing Organization
1960s
1970s
- Jun 30, 1971
Belmora — Marketing Organization
- Dec 29, 1971
Fresenius — Marketing Organization
- Feb 14, 1972
West-Ward Pharmaceutical — Marketing Organization
- Feb 15, 1972
Abraxis — NDA Secondary Org
- Feb 15, 1972
Abraxis — Marketing Organization
- Apr 6, 1972
Hospira — NDA Secondary Org
- Apr 6, 1972
Hospira — Marketing Organization
- Jun 23, 1972
Lutipold — Marketing Organization
- Jun 23, 1972
Sankyo — Marketing Organization
- Dec 20, 1972
Abbott — NDA Secondary Org
- Dec 20, 1972
Abbott — Marketing Organization
- Dec 3, 1973
Belmar Pharmacy — Marketing Organization
- Feb 20, 1974
Watson Pharmaceuticals — Marketing Organization
- Apr 11, 1974
Bluepharma — Marketing Organization
- Apr 11, 1974
Bionpharma Inc — Marketing Organization
- Mar 18, 1975
Del Laboratories — Marketing Organization
- Mar 28, 1975
Meridien Medical Technologies, Inc. — NDA Secondary Org
- Apr 30, 1975
Elkins Sinn — Marketing Organization
- Aug 29, 1975
American Home Products — Marketing Organization
- Sep 17, 1975
International Medication — NDA Secondary Org
- Sep 17, 1975
International Medication — Marketing Organization
- Jul 29, 1976
Akorn, Inc. — NDA Secondary Org
- Jan 18, 1977
Carlisle — Marketing Organization
- Mar 14, 1977
Lyphomed, Inc. — Marketing Organization
1980s
- Apr 22, 1981
Baxalta — NDA Secondary Org
- Apr 22, 1981
Baxter — NDA Secondary Org
- Aug 17, 1981
Taro Pharmaceuticals — Marketing Organization
- Aug 9, 1982
G D Searle — Marketing Organization
- Nov 18, 1982
Wockhardt — Marketing Organization
- Jun 10, 1983
Kendall McGaw Laboratories — Marketing Organization
- Aug 17, 1983
Pharmaton — Marketing Organization
- Mar 30, 1984
B. Braun — NDA Secondary Org
- Dec 21, 1984
Roche — Marketing Organization
- Dec 21, 1984
Roche — NDA Secondary Org
- Jan 22, 1985
Deproco — Marketing Organization
- Apr 3, 1985
Hikma — Marketing Organization
- Jun 30, 1989
Paco — Marketing Organization
- Jun 30, 1989
R.P. Scherer — Marketing Organization
1990s
- Dec 30, 1992
Actavis — Marketing Organization
- Dec 30, 1992
Teva — NDA Secondary Org
- Feb 26, 1993
Kodak — Marketing Organization
- Apr 29, 1993
Cosette — Marketing Organization
- Dec 21, 1995
iOMEDICO AG — Marketing Organization
- Dec 21, 1995
iOMEDICO AG — NDA Secondary Org
- May 21, 1996
Noven Therapeutics — NDA Secondary Org
- Mar 19, 1999
Teikoku Pharma USA, Inc. — NDA Secondary Org
2000s
- Jan 1, 2002
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2002
Earliest Phase 3 Sponsor(trial)
- Feb 12, 2003
SENTISS — Marketing Organization
- May 23, 2003
Amphastar Pharmaceuticals — Marketing Organization
- May 23, 2003
Amphastar Pharmaceuticals — NDA Secondary Org
- Aug 18, 2003
Fougera — Marketing Organization
- Aug 27, 2003
Tolmar Inc. — Marketing Organization
- Aug 27, 2003
Encube Ethicals Pvt. Ltd. — Marketing Organization
- Sep 25, 2003
Hi Tech Pharmaceuticals — Marketing Organization
- Dec 19, 2003
Dentsply International — Marketing Organization
- Jan 1, 2004
Earliest Phase 1 Sponsor(trial)
- May 6, 2004
Vyteris — Marketing Organization
- May 6, 2004
Vyteris — NDA Secondary Org
- Oct 26, 2004
Empi — Marketing Organization
- Oct 26, 2004
Empi — NDA Secondary Org
- Jun 23, 2005
Galen — Marketing Organization
- Jun 23, 2005
Warner Chilcott — NDA Secondary Org
- Jun 29, 2006
Taro Pharmaceuticals — NDA Secondary Org
- Feb 27, 2007
Lannett Company, Inc. — Marketing Organization
- Feb 27, 2007
Chartwell Pharmaceuticals — Marketing Organization
- Aug 16, 2007
Powder Pharmaceuticals — NDA Secondary Org
- Oct 7, 2008
Thea Pharma — Marketing Organization
- Oct 7, 2008
Thea Pharma — NDA Secondary Org
2010s
- May 23, 2011
Septodont — Marketing Organization
- Mar 14, 2013
Aurobindo Pharma — Marketing Organization
- Mar 14, 2013
Eugia Pharma — Marketing Organization
- Mar 12, 2014
Pharmaceutical Associates — Marketing Organization
- Apr 28, 2014
Sagent Pharmaceuticals, Inc. — Marketing Organization
- Aug 7, 2015
Amneal Pharmaceuticals — Marketing Organization
- Aug 7, 2015
Mylan — Marketing Organization
- Aug 14, 2015
Daiichi Sankyo — Marketing Organization
- Feb 1, 2016
Teligent Pharmaceuticals — Marketing Organization
- Sep 9, 2016
Glenmark Pharmaceuticals — Marketing Organization
- Mar 10, 2017
Alkem Labs Ltd — Marketing Organization
- Sep 20, 2017
Novast Labs — Marketing Organization
- Sep 20, 2017
Rising Pharmaceuticals — Marketing Organization
- Sep 20, 2017
RiconPharma — Marketing Organization
- Sep 25, 2017
Vitruvias Therapeutics — Marketing Organization
- Jan 16, 2018
Teva — Marketing Organization
- Feb 28, 2018
Scilex Pharms Inc — NDA Secondary Org
- Feb 28, 2018
Scilex Pharms Inc — Marketing Organization
- Feb 28, 2018
Sorrento Therapeutics, Inc. — NDA Secondary Org
- Apr 18, 2018
Spectra Medical Devices — Marketing Organization
- Aug 3, 2018
B. Braun — Marketing Organization
- Nov 23, 2018
Alembic — Marketing Organization
- Dec 11, 2018
Strides Pharma Science — Marketing Organization
- Dec 12, 2018
ACP Nimble — Marketing Organization
- Dec 12, 2018
G & W Laboratories Inc. — Marketing Organization
- Oct 17, 2019
Praxgen Pharma — Marketing Organization
- Oct 17, 2019
Geneyork Pharmaceuticals — Marketing Organization
2020s
- Mar 16, 2020
Macleods Pharmaceuticals, Ltd — Marketing Organization
- Mar 16, 2020
Neogen — Marketing Organization
- Apr 30, 2020
Rhodes Pharmaceuticals, L.P. — Marketing Organization
- Apr 30, 2020
IBSA Institut Biochimique SA — Marketing Organization
- May 7, 2020
Huons Co.,Ltd. — Marketing Organization
- Dec 1, 2020
Noven Therapeutics — Marketing Organization
- Dec 1, 2020
Hisamitsu Pharmaceutical Co., Inc. — Marketing Organization
- Jan 5, 2021
Dr. Reddy's Laboratories — Marketing Organization
- Apr 20, 2021
Quagen Pharma — Marketing Organization
- Apr 29, 2021
NAL Pharmaceuticals — Marketing Organization
- Jul 27, 2021
Acrux Ltd — Marketing Organization
- Jul 27, 2021
Padagis Us — Marketing Organization
- Nov 8, 2021
Aspiro — Marketing Organization
- Mar 23, 2022
Novitium Pharma — Marketing Organization
- Mar 23, 2022
Ani Pharmaceuticals — Marketing Organization
- May 5, 2022
Sintetica SA — Marketing Organization
- Jun 9, 2022
AFAXYS — Marketing Organization
- Mar 28, 2023
Rubicon Research — Marketing Organization
- Jun 16, 2023
Mankind Pharma — Marketing Organization
Indications
Approved for
Studied for
- Abdominal Injuries · Phase 4
- Abdominal Neoplasms · Phase 4
- Abdominal Pain · Phase 4
- Abortion, Induced · Phase 3
- Abortion, Missed · Phase 3
- Abortion, Spontaneous · Phase 3
- Abscess · Phase 4
- Achilles Tendon · Phase 4
- Acne Vulgaris · Phase 4
- Acute Lung Injury · Phase 4
- Acute Pain · Phase 4
- Adenoids · Phase 4
- Adjuvants, Anesthesia · Phase 4
- Aged · Phase 4
- Allergy and Immunology · Phase 3
- Alopecia · Phase 4
- Alopecia Areata · Phase 4
- alpha 1-Antitrypsin Deficiency · Phase 1
- Amputation, Surgical · Phase 4
- Amyotrophic Lateral Sclerosis · Phase 1
- Analgesia · Phase 4
- Analgesics · Phase 4
- Analgesics, Opioid · Phase 4
- Anemia, Sickle Cell · Phase 2
- Anesthesia · Phase 4
- Anesthesia and Analgesia · Phase 4
- Anesthesia, Conduction · Phase 4
- Anesthesia, Dental · Phase 4
- Anesthesia, Epidural · Phase 4
- Anesthesia, General · Phase 4
- Anesthesia, Intravenous · Phase 4
- Anesthesia, Local · Phase 4
- Anesthesia, Obstetrical · Phase 1
- Anesthesia Recovery Period · Phase 3
- Anesthesia, Spinal · Phase 4
- Anesthetics, Local · Phase 4
- Angina Pectoris · Phase 4
- Ankle Injuries · Phase 3
- Anxiety · Phase 4
- Anxiety Disorders · Phase 3
- Aorta · Phase 4
- Aortic Aneurysm, Abdominal · Phase 4
- Appendicitis · Phase 4
- Arthritis · Phase 4
- Arthritis, Juvenile · Phase 3
- Arthropathy, Neurogenic · Phase 4
- Arthroplasty, Replacement, Hip · Phase 3
- Arthroplasty, Replacement, Knee · Phase 4
- Attention Deficit Disorder with Hyperactivity · Early Phase 1
- Back Pain · Phase 4
- Bacteremia · Phase 4
- Bariatric Surgery · Phase 4
- Behavior · Phase 4
- beta-Thalassemia · Phase 2
- Blood Gas Analysis · Phase 4
- Blood Pressure · Phase 4
- Body Fat Distribution · Phase 1/Phase 2
- Bone Marrow Diseases · Phase 3
- Bowen's Disease · Phase 1
- Brachial Plexus Block · Phase 4
- Brain Concussion · Phase 2
- Brain Injuries, Traumatic · Phase 4
- Brain Neoplasms · Phase 1
- Breast Neoplasms · Phase 4
- Bronchiectasis · Phase 3
- Bronchoscopy · Phase 3
- Bundle-Branch Block · Phase 2
- Buprenorphine · Phase 4
- Burns · Phase 4
- Bursitis · Phase 4
- Calculi · Phase 3
- Cancer Pain · Phase 2/Phase 3
- Carcinoma, Non-Small-Cell Lung · Phase 3
- Carcinoma, Squamous Cell · Phase 1
- Cardiac Catheterization · Phase 2/Phase 3
- Cardiotoxicity · Phase 1
- Cardiovascular Diseases · Phase 4
- Carpal Tunnel Syndrome · Phase 4
- Cataract · Phase 3
- Catheter-Related Infections · Phase 4
- Catheters · Phase 4
- Central Nervous System Depressants · Phase 4
- Cerebral Palsy · Phase 4
- Cerebrospinal Fluid Leak · Phase 4
- Cervix Uteri · Phase 4
- Cesarean Section · Phase 4
- Child · Phase 3
- Cholecystectomy, Laparoscopic · Phase 4
- Cholecystitis · Phase 2/Phase 3
- Cholecystitis, Acute · Phase 4
- Cholecystolithiasis · Phase 4
- Cholelithiasis · Phase 4
- Chronic Pain · Phase 4
- Cicatrix · Phase 4
- Cicatrix, Hypertrophic · Phase 4
- Clubfoot · Phase 4
- Cocaine-Related Disorders · Phase 2
- Cognition · Phase 1
- Cognition Disorders · Phase 4
- Cognitive Dysfunction · Phase 1/Phase 2
- Colles' Fracture · Phase 3
- Colonic Neoplasms · Phase 4
- Colonic Polyps · Early Phase 1
- Colonoscopy · Phase 4
- Colorectal Neoplasms · Phase 4
- Colorectal Surgery · Phase 3
- Common Cold · Phase 3
- Complex Regional Pain Syndromes · Phase 4
- Constipation · Phase 4
- Consumer Behavior · Phase 4
- Contraception · Phase 4
- Contusions · Phase 4
- Corneal Endothelial Cell Loss · Phase 3
- Coronary Artery Disease · Phase 4
- Coronavirus Infections · Phase 3
- Cough · Phase 4
- COVID-19 · Phase 3
- Craniotomy · Phase 2
- Critical Illness · Phase 4
- Cystitis, Interstitial · Phase 2
- Cystocele · Phase 4
- Cystoscopy · Phase 4
- Defecation · Phase 2
- Deglutition Disorders · Phase 2
- Dental Anxiety · Phase 4
- Dental Pulp Diseases · Phase 4
- Dermatologic Surgical Procedures · Phase 2/Phase 3
- Dermatology · Phase 4
- Dexmedetomidine · Phase 4
- Diabetes Mellitus · Phase 4
- Diabetic Neuropathies · Phase 4
- Digestive System Diseases · Phase 3
- Dilatation · Phase 4
- Diverticulitis · Phase 2
- Diverticulitis, Colonic · Phase 4
- Dizziness · Phase 4
- Drug Delivery Systems · Phase 1
- Drug Interactions · Phase 2/Phase 3
- Drug Misuse · Phase 4
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Drugs, Investigational · Phase 4
- Dyslexia · Phase 4
- Dysmenorrhea · Phase 2
- Dyspareunia · Phase 3
- Dyspepsia · Phase 3
- Dysuria · Phase 3
- Ecchymosis · Phase 4
- Ecthyma · Phase 2
- Eczema · Phase 4
- Edema · Phase 4
- Ehlers-Danlos Syndrome · Phase 4
- Elbow · Phase 4
- Elective Surgical Procedures · Phase 2/Phase 3
- Emergencies · Phase 3
- Endometrial Neoplasms · Phase 2
- Endometriosis · Phase 2
- Endophthalmitis · Phase 4
- Endoscopy · Phase 4
- Endoscopy, Digestive System · Phase 4
- Enhanced Recovery After Surgery · Phase 4
- Epidermal Cells · Phase 4
- Epilepsy · Phase 4
- Epiretinal Membrane · Phase 4
- Epistaxis · Early Phase 1
- Esophagitis · Phase 2
- Exercise · Phase 1/Phase 2
- Eye Diseases · Phase 4
- Eye Diseases, Hereditary · Phase 4
- Eyelid Diseases · Phase 4
- Eyelids · Phase 4
- Facial Injuries · Phase 3
- Facial Neuralgia · Phase 3
- Facial Pain · Phase 4
- Facial Paralysis · Phase 4
- Family Planning Services · Phase 4
- Fasciitis, Plantar · Phase 4
- Fatigue · Phase 3
- Fatigue Syndrome, Chronic · Phase 2
- Fecal Incontinence · Phase 2
- Feeding and Eating Disorders · Phase 2
- Fentanyl · Phase 4
- Fetus · Phase 3
- Fibroins · Phase 4
- Fibromyalgia · Phase 3
- Fibrosis · Phase 4
- Filtration · Phase 3
- Fissure in Ano · Phase 4
- Fracture Dislocation · Phase 3
- Fractures, Bone · Phase 4
- Fractures, Closed · Phase 4
- Gabapentin · Phase 3
- Gallstones · Phase 4
- Gastroesophageal Reflux · Phase 3
- Gastrointestinal Microbiome · Phase 2
- General Surgery · Phase 4
- Genital Diseases, Female · Phase 4
- Genital Neoplasms, Female · Phase 4
- Geographic Atrophy · Phase 2
- Glaucoma · Phase 1/Phase 2
- Glioblastoma · Phase 1
- Glycogen Storage Disease Type II · Phase 1
- Granuloma Annulare · Phase 4
- Hallux Valgus · Phase 4
- Hand Injuries · Phase 4
- Headache · Phase 4
- Headache Disorders · Phase 4
- Head and Neck Neoplasms · Phase 2
- Healthy Volunteers · Phase 4
- Heart Arrest · Phase 3
- Heart Defects, Congenital · Phase 4
- Heart Diseases · Phase 4
- Heart Failure · Phase 1/Phase 2
- Heart Valve Diseases · Phase 2
- Heating · Early Phase 1
- Hematocele · Phase 3
- Hematoma · Phase 4
- Hematuria · Phase 3
- Hemodynamics · Phase 4
- Hemorrhage · Phase 4
- Hemorrhoidectomy · Phase 2/Phase 3
- Hemorrhoids · Phase 4
- Hernia, Hiatal · Phase 4
- Hernia, Inguinal · Phase 3
- Herpes Labialis · Phase 2
- Hidradenitis Suppurativa · Early Phase 1
- Hip Dislocation · Phase 4
- Hip Fractures · Phase 4
- HIV Infections · Phase 4
- Human papillomavirus 16 · Phase 4
- Humeral Fractures · Early Phase 1
- Hunger · Phase 4
- Hydrocephalus · Phase 4
- Hyperalgesia · Phase 2
- Hypertension · Phase 4
- Hypertension, Pulmonary · Phase 1
- Hyperthermia · Phase 1/Phase 2
- Hypesthesia · Phase 4
- Hypotension · Phase 4
- Hysterectomy · Phase 4
- Hysteroscopy · Phase 4
- Ileus · Phase 4
- Infant, Premature · Phase 1
- Infertility · Phase 2
- Infertility, Female · Phase 4
- Inflammation · Phase 3
- Inflammatory Bowel Diseases · Phase 2
- Inhalation · Phase 4
- Injections, Intravenous · Phase 4
- Injections, Spinal · Phase 4
- Intensive Care Units · Phase 3
- Intestinal Diseases · Phase 4
- Intestinal Neoplasms · Phase 4
- Intestinal Pseudo-Obstruction · Phase 4
- Intestine, Large · Phase 4
- Intraocular Pressure · Phase 4
- Intraoperative Awareness · Phase 4
- Intrauterine Devices · Phase 4
- Intubation · Phase 4
- Intubation, Intratracheal · Phase 4
- Irritable Bowel Syndrome · Phase 2
- Ischemic Stroke · Phase 2
- Joint Diseases · Phase 4
- Keloid · Phase 4
- Keratoacanthoma · Phase 4
- Keratosis, Actinic · Phase 4
- Ketamine · Phase 3
- Kidney Diseases · Phase 3
- Kidney Neoplasms · Phase 4
- Kidney Transplantation · Phase 4
- Knee Injuries · Phase 3
- Labor Pain · Phase 4
- Lacerations · Phase 4
- Laminaria · Phase 4
- Laminectomy · Phase 4
- Laparoscopy · Phase 4
- Laryngoscopy · Phase 4
- Latency Period, Psychological · Phase 2
- Leg Ulcer · Phase 2
- Leiomyoma · Phase 4
- Leukemia · Phase 4
- Lichen Planus · Phase 4
- Lidocaine · Phase 4
- Limb Deformities, Congenital · Phase 4
- Linear Energy Transfer · Phase 4
- Lip Diseases · Phase 3
- Lipectomy · Phase 4
- Live Birth · Phase 4
- Liver Cirrhosis · Phase 1
- Liver Neoplasms · Phase 2/Phase 3
- Low Back Pain · Phase 4
- Lumbar Vertebrae · Phase 2
- Lung Diseases · Phase 4
- Lung Diseases, Interstitial · Phase 2/Phase 3
- Lung Neoplasms · Phase 4
- Lymphadenopathy · Phase 3
- Lymphoma · Phase 4
- Lymphoma, Non-Hodgkin · Phase 4
- Magnesium Sulfate · Phase 4
- Magnetic Resonance Imaging · Phase 3
- Malabsorption Syndromes · Phase 3
- Malnutrition · Phase 3
- Mammaplasty · Phase 3
- Mandibular Nerve Injuries · Phase 1
- Mastectomy · Phase 4
- Mastectomy, Radical · Phase 1/Phase 2
- Mastectomy, Segmental · Phase 4
- Mastodynia · Phase 4
- Memory Disorders · Phase 1/Phase 2
- Menopause · Phase 3
- Migraine Disorders · Phase 4
- Migraine with Aura · Phase 1/Phase 2
- Molar, Third · Phase 4
- Monitoring, Intraoperative · Phase 4
- Morphine · Phase 4
- Morton Neuroma · Phase 1
- Motor Activity · Phase 2
- Mucositis · Phase 3
- Multiple Sclerosis · Phase 4
- Muscle Fatigue · Phase 3
- Musculoskeletal Diseases · Phase 4
- Musculoskeletal Pain · Phase 4
- Mydriasis · Phase 3
- Myoclonus · Phase 4
- Myofascial Pain Syndromes · Phase 4
- Narcotics · Phase 4
- Nasal Surgical Procedures · Phase 4
- Nasolabial Fold · Phase 4
- Nausea · Phase 4
- Neck Pain · Phase 4
- Neisseria gonorrhoeae · Phase 4
- Neoplasm Metastasis · Phase 2/Phase 3
- Neoplasms · Phase 4
- Neoplasms, Adnexal and Skin Appendage · Phase 2
- Neoplasms, Cystic, Mucinous, and Serous · Phase 1
- Nephrostomy, Percutaneous · Phase 4
- Nerve Block · Phase 4
- Nerve Compression Syndromes · Phase 4
- Nerve Degeneration · Phase 4
- Nerve Fibers · Phase 4
- Neuralgia · Phase 4
- Neuralgia, Postherpetic · Phase 4
- Neurodermatitis · Phase 4
- Neurofibromatoses · Phase 4
- Neuromuscular Blockade · Phase 4
- Neurosurgery · Phase 4
- Nociceptive Pain · Phase 1
- Nose Deformities, Acquired · Phase 4
- Obesity · Phase 4
- Obesity, Morbid · Phase 3
- Obstetric Labor Complications · Phase 2/Phase 3
- Only Child · Phase 4
- Ophthalmology · Phase 4
- Opioid-Related Disorders · Phase 4
- Oral Hemorrhage · Phase 4
- Oral Surgical Procedures · Phase 3
- Oropharyngeal Neoplasms · Phase 1
- Orthopedic Procedures · Phase 4
- Osteoarthritis, Hip · Phase 4
- Osteoarthritis, Knee · Phase 4
- Osteoporosis, Postmenopausal · Phase 3
- Otitis Media · Phase 3
- Oximetry · Phase 3
- Paget Disease, Extramammary · Phase 3
- Pain Management · Phase 4
- Pain Perception · Phase 4
- Pancreatectomy · Phase 4
- Pancreatic Neoplasms · Phase 2
- Pancreatitis, Chronic · Phase 2
- Papillomaviridae · Phase 1
- Parathyroid Diseases · Phase 3
- Parathyroid Neoplasms · Phase 4
- Parturition · Phase 4
- Pathologic Processes · Phase 3
- Patient Satisfaction · Phase 4
- Pediatric Dentistry · Phase 4
- Pediatrics · Phase 4
- Pelvic Floor Disorders · Phase 4
- Pelvic Neoplasms · Phase 1
- Pelvic Organ Prolapse · Phase 4
- Pelvic Pain · Phase 4
- Periarthritis · Phase 3
- Perineum · Phase 4
- Periodontal Diseases · Phase 4
- Periodontitis · Phase 4
- Peripheral Nervous System Diseases · Phase 4
- Phantom Limb · Phase 4
- Pharmacokinetics · Phase 4
- Pharyngitis · Phase 4
- Pharynx · Phase 4
- Phlebotomy · Phase 2/Phase 3
- Phytotherapy · Phase 4
- Pilonidal Sinus · Phase 4
- Pleural Diseases · Phase 3
- Pleural Effusion · Phase 4
- Pleural Effusion, Malignant · Early Phase 1
- Pneumonia · Phase 4
- Pneumoperitoneum · Phase 4
- Polyps · Phase 4
- Post-Dural Puncture Headache · Phase 4
- Postoperative Cognitive Complications · Phase 2
- Postoperative Complications · Phase 4
- Postoperative Nausea and Vomiting · Phase 4
- Postoperative Pain · Phase 4
- Pre-Eclampsia · Phase 3
- Pregnancy · Phase 3
- Pregnancy Complications · Phase 4
- Pregnancy, Unwanted · Phase 3
- Premature Ejaculation · Phase 3
- Premenstrual Syndrome · Early Phase 1
- Pressoreceptors · Phase 4
- Procedural Pain · Phase 4
- Procedural Sedation · Phase 4
- Propofol · Phase 4
- Prostatectomy · Phase 4
- Prostatic Neoplasms · Phase 4
- Prostatitis · Phase 2
- Prurigo · Phase 4
- Pruritus · Phase 2
- Psoriasis · Phase 4
- Psychological Distress · Phase 4
- Pterygium · Phase 4
- Pudendal Neuralgia · Phase 4
- Pulmonary Arterial Hypertension · Phase 4
- Pulpitis · Phase 4
- Quality of Life · Phase 2/Phase 3
- Radial Artery · Phase 4
- Radiation Oncology · Phase 3
- Radiculopathy · Phase 4
- Rectal Diseases · Phase 2/Phase 3
- Rectal Fistula · Phase 4
- Rectal Neoplasms · Phase 4
- Renal Colic · Phase 4
- Respiratory Distress Syndrome · Phase 3
- Respiratory Insufficiency · Phase 3
- Respiratory Tract Infections · Phase 4
- Retinal Detachment · Phase 4
- Retinal Perforations · Phase 4
- Rhytidoplasty · Phase 4
- Rib Fractures · Phase 4
- Ropivacaine · Phase 3
- Rotator Cuff Injuries · Phase 4
- Sarcoidosis · Phase 2/Phase 3
- Sciatica · Phase 4
- Sciatic Neuropathy · Phase 4
- Scleroderma, Localized · Phase 4
- Scleroderma, Systemic · Phase 2/Phase 3
- Sclerosis · Phase 3
- Scoliosis · Phase 4
- Scrotum · Phase 3
- Sentinel Lymph Node · Phase 3
- Sexual Dysfunction, Physiological · Phase 4
- Shock, Septic · Phase 3
- Shoulder Dislocation · Phase 4
- Shoulder Impingement Syndrome · Phase 4
- Shoulder Pain · Phase 4
- Sinusitis · Phase 3
- Skin Neoplasms · Early Phase 1
- Sleep Apnea, Obstructive · Phase 3
- Sleep Apnea Syndromes · Phase 3
- Sleep Disorders, Intrinsic · Phase 4
- Snake Bites · Phase 2/Phase 3
- Spasm · Phase 2/Phase 3
- Spermatocele · Phase 3
- Sphenopalatine Ganglion Block · Phase 2
- Spinal Cord Injuries · Phase 4
- Spinal Diseases · Phase 4
- Spinal Fusion · Phase 4
- Spinal Injuries · Phase 4
- Spinal Stenosis · Phase 4
- Spine · Early Phase 1
- Spondylosis · Phase 4
- Sprains and Strains · Phase 4
- Squamous Cell Carcinoma of Head and Neck · Phase 3
- Stellate Ganglion · Phase 2
- Sternotomy · Phase 4
- Stomatitis · Phase 4
- Stress Disorders, Post-Traumatic · Early Phase 1
- Stroke · Phase 3
- Surgical Wound Infection · Phase 2/Phase 3
- Syphilis · Phase 3
- Tattooing · Phase 4
- Temporomandibular Joint Disorders · Phase 2/Phase 3
- Tendon Injuries · Phase 3
- Tennis Elbow · Phase 4
- Tenosynovitis · Phase 4
- Tension-Type Headache · Phase 2
- Term Birth · Phase 4
- Testicular Hydrocele · Phase 3
- Thermosensing · Phase 4
- Thoracic Surgery · Phase 4
- Thyroid Diseases · Phase 4
- Thyroidectomy · Phase 4
- Thyroid Gland · Early Phase 1
- Thyroid Neoplasms · Phase 4
- Tinnitus · Phase 4
- Tonsillectomy · Phase 3
- Tonsillitis · Phase 4
- Tooth · Phase 1/Phase 2
- Tooth Abnormalities · Phase 4
- Touch Perception · Phase 4
- Traumatology · Phase 4
- Trigeminal Neuralgia · Phase 4
- Trigger Finger Disorder · Phase 4
- Tuberculosis · Phase 2/Phase 3
- Ulcer · Phase 2
- Ureteral Diseases · Phase 3
- Ureteral Neoplasms · Phase 3
- Urethral Diseases · Phase 4
- Urethral Stricture · Phase 2
- Urinary Bladder · Phase 4
- Urinary Bladder Diseases · Phase 2
- Urinary Bladder Neoplasms · Phase 4
- Urinary Bladder, Neurogenic · Phase 4
- Urinary Bladder, Overactive · Phase 4
- Urinary Calculi · Early Phase 1
- Urinary Incontinence · Phase 4
- Urinary Incontinence, Stress · Phase 4
- Urinary Incontinence, Urge · Phase 4
- Urinary Tract Infections · Phase 3
- Urination Disorders · Phase 4
- Urolithiasis · Phase 4
- Urological Manifestations · Phase 3
- Uterine Cervical Dysplasia · Phase 2
- Uterine Diseases · Phase 4
- Uterine Myomectomy · Phase 2/Phase 3
- Uterine Neoplasms · Phase 4
- Uterine Prolapse · Phase 4
- Uterus · Phase 2
- Vagina · Phase 4
- Vaginal Discharge · Phase 3
- Vaginitis · Phase 4
- Vaginosis, Bacterial · Phase 4
- Varicella Zoster Virus Infection · Phase 2/Phase 3
- Varicose Ulcer · Phase 2
- Varicose Veins · Phase 4
- Vascular Diseases · Phase 4
- Venous Cutdown · Phase 4
- Venous Thromboembolism · Phase 2/Phase 3
- Vesico-Ureteral Reflux · Phase 3
- Vestibular Diseases · Phase 1
- Vision, Ocular · Phase 4
- Vitrectomy · Phase 4
- Vitreoretinal Surgery · Phase 4
- Vitreous Detachment · Phase 4
- Vitreous Hemorrhage · Phase 4
- Vomiting · Phase 4
- Vulvar Diseases · Phase 4
- Vulvar Vestibulitis · Phase 2
- Vulvodynia · Phase 3
- Vulvovaginitis · Phase 4
- Work of Breathing · Phase 4
- Wound Healing · Phase 1
- Wounds and Injuries · Phase 4
Mechanism of action
- Sodium channel alpha subunitBLOCKER
Sodium channel alpha subunit blocker
- Sodium channel protein type 1 subunit alpha (SCN1A) ↗
- Sodium channel protein type 5 subunit alpha (SCN5A) ↗
- Sodium channel protein type 4 subunit alpha (SCN4A) ↗
- Sodium channel protein type 7 subunit alpha (SCN7A) ↗
- Sodium channel protein type 2 subunit alpha (SCN2A) ↗
- Sodium channel protein type 9 subunit alpha (SCN9A) ↗
- Sodium channel protein type 3 subunit alpha (SCN3A) ↗
- Sodium channel protein type 11 subunit alpha (SCN11A) ↗
- Sodium channel protein type 8 subunit alpha (SCN8A) ↗
- Sodium channel protein type 10 subunit alpha (SCN10A) ↗
- Sodium channel protein type I alpha subunit
- Sodium channel protein type V alpha subunit
- Sodium channel protein type IV alpha subunit
- Sodium channel protein type VII alpha subunit
- Sodium channel protein type IX alpha subunit
- Sodium channel protein type II alpha subunit
- Sodium channel protein type III alpha subunit
- Sodium channel protein type XI alpha subunit
- Sodium channel protein type VIII alpha subunit
- Sodium channel protein type X alpha subunit
- Sodium channel alpha subunits; brain (Types I, II, III)
- Unspecified targetUnclear
Unclear
Combination products
decadron w/ xylocaine
with dexamethasone
duocaine
with levobupivacaine
embolex
with heparin, dihydroergotamine
emla
with prilocaine
Also known as anesthetic neo, emla 1 hour, oraqix
lanabiotic
rocephin
with ceftriaxone
synera
with tetracaine
Also known as pliaglis
terramycin
with oxytetracycline
xylocaine dental with epinephrine
with epinephrine
Also known as alphacaine hydrochloride w/ epinephrine, iontocaine, lidocaton, lidosite topical system, lignospan forte, lignospan standar, octocaine, xylocaine w/ epinephrine
Approval history
- approvedNov 19, 1948
Chemistry & pharmacology
SMILES
CCN(CC)CC(=O)Nc1c(C)cccc1C- Mol. weight
- 234.34 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral, Parenteral, Topical
- Availability
- Prescription Only
Oral
Yes
Parenteral
Yes
Topical
Yes
Sources
- ChEMBLCHEMBL79 ↗
- WikipediaLidocaine ↗
- NCATS98PI200987 ↗
- ChEMBLCHEMBL541521 ↗
- ChEMBLCHEMBL2106004 ↗
- ChEMBLCHEMBL1200409 ↗
Also known as
- 2-(diethylamino)-2',6'-acetoxylidide
- 2-(diethylamino)-2',6'-acetoxylidide
- 2-(diethylamino)-n-(2,6-dimethylphenyl)acetamide
- 2-(diethylamino)-n-(2,6-dimethylphenyl)acetamide
- 2-(propylamino)-o-propionotoluidide
- 2-(propylamino)-o-propionotoluidide
- akten
- akten
- alphacaine
- alphacaine
- alphacaine hcl
- alphacaine hcl
- alpha-diethylamino-2,6-dimethylacetanilide
- alpha-diethylamino-2,6-dimethylacetanilide
- alpha-n-propylamino-2-methylpropionanilide
- alpha-n-propylamino-2-methylpropionanilide
- anestacon
- anestacon
- anodesyn
- benzoylmethylecgonine
- benzoylmethylecgonine
- benzoylmethylecgonine
- beta-cocain
- beta-cocain
- bismodyne
- bisoxatin acetate
- bisoxatin acetate
- bisoxatin acetate
- bisoxatin acetate
- bisoxatin acetate
- bisoxatin acetate
- bradosol plus
- bupivacaine / lidocaine
- calgel
- chlorhexidine gluconate - lidocaine
- chlorhexidine gluconate, lidocaine drug combination
- chlorhexidine gluconate-lidocaine hydrochloride
- co-phenylcaine fte
- dalcaine
- denela
- dentipatch
- dentipatch
- dequaspray
- d-gluconic acid, compd. with n,n''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediimidamide (2:1), mixt. with 2-(diethylamino)-n-(2,6-dimethylphenyl)acetamide monohydrochloride
- dihydroergotamine-heparin
- duncaine
- embolex
- embolex
- embolex
- emla
- emla
- emla
- emla
- esracaine
- eutectic lidocaine-prilocaine
- eutectic mixture of local anesthetics
- exodol
- germoloids
- germoloids complete
- hemocane
- hemocane
- heparin-dhe
- heparin-dihydergot
- heparin-dihydergot 2500
- heparin-dihydroergotamine
- iglu
- instillagel
- instillagel
- instillagel
- iontocaine
- iontocaine
- laryngojet
- laryng-o-jet kit
- laryng-o-jet kit
- laryngotracheal anesthesia kit
- laryngotracheal anesthesia kit
- lasotin
- laxonalin
- licocaine
- lidocaine
- lidocaine
- lidocaine
- lidocaine
- lidocaine
- lidocaine
- lidocaine
- lidocaine
- lidocaine
- lidocaine and tetracaine
- lidocaine hcl
- lidocaine hcl
- lidocaine hcl
- lidocaine hydrochloride
- lidocaine hydrochloride
- lidocaine hydrochloride
- lidocaine hydrochloride
- lidocaine hydrochloride anhydrous
- lidocaine hydrochloride hydrate
- lidocaine hydrochloride hydrate
- lidocaine hydrochloride hydrate
- lidocaine hydrochloride viscous
- lidocaine hydrochloride viscous
- lidocaine / prilocaine
- lidocaine / prilocaine
- lidocaine-prilocaine cream
- lidocaine viscous
- lidocaine viscous
- lidocaton
- lidocaton
- lidoderm
- lidoderm
- lidoderm
- lido hcl
- lidopen
- lidopen
- lignocaine
- lignocaine
- lignocaine
- lignocaine
- lignocaine
- lignocaine
- lignocaine
- lignocaine hcl
- lignocaine hcl
- lignokent
- lignospan special
- lignostab
- lignostab-a
- lignostab a 100
- lignostab n
- liposomal lidocaine
- lmx 4
- lta ii kit
- lta ii kit
- medijel
- mono-embolex nm
- nanocap
- octocaine
- octocaine
- oragard
- oraqix
- oraqix
- oraqix
- pediatric lta kit
- pediatric lta kit
- preparation h
- preparation-h
- psd502
- psd502
- psd502
- psd 502
- psd-502
- rmn3001
- solarcaine
- t2380
- tempe
- vagisil
- vagisil
- versatis
- versatis
- xylocain
- xylocaine
- xylocaine
- xylocaine
- xylocaine
- xylocaine dental
- xylocaine viscous
- xylocaine viscous
- xylodase
- xylotox
- xylotox
- xylotox e80
- zingo
- zingo
- α-diethylamino-2,6-dimethylacetanilide
- α-diethylamino-2,6-dimethylacetanilide
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07273006 | Phase 4 | Sep 1, 2026 | Jagiellonian University, Medical University of Warsaw, Universidad Complutense de Madrid, Universidad Francisco de Vitoria |
| NCT07224711 | Phase 4 | Jun 1, 2026 | Vanderbilt University |
| NCT07273916 | Phase 2 | Mar 31, 2026 | Hexsel Dermatology Clinic |
| NCT07267897 | N/A | Mar 15, 2026 | Sakarya University |
| NCT07274254 | Phase 3 | Mar 1, 2026 | University of Nantes |
| NCT07268118 | Phase 2 | Jan 31, 2026 | Harvard University |
| NCT07250867 | Phase 2 | Jan 31, 2026 | Assiut University |
| NCT07268924 | Phase 4 | Jan 31, 2026 | Assiut University |
| NCT07278323 | Phase 4 | Jan 1, 2026 | University of California, San Francisco |
| NCT07283874 | Phase 4 | Dec 31, 2025 | Assiut University |
| NCT07298746 | N/A | Dec 31, 2025 | Sohag University |
| NCT07294118 | Phase 2 | Dec 31, 2025 | University of Texas, Galveston |
| NCT07248202 | N/A | Dec 31, 2025 | Cairo University |
| NCT07262242 | N/A | Dec 31, 2025 | Cairo University |
| NCT07231614 | Phase 4 | Dec 20, 2025 | Universidad Austral de Chile |
| NCT07299630 | Phase 3 | Dec 20, 2025 | Ain Shams University |
| NCT07304206 | N/A | Dec 8, 2025 | Inonu University |
| NCT07203274 | N/A | Dec 1, 2025 | Aalborg University |
| NCT07296653 | Early Phase 1 (Phase 1) | Dec 1, 2025 | University of Athens |
| NCT07245121 | N/A | Nov 30, 2025 | University of Athens |
Organizations
Research & Development (935)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Cairo University | Academic/Hospital | 52 | 50 | 5 | 2014 |
| Assiut University | Academic/Hospital | 50 | 50 | 5 | 2013 |
| Ain Shams University | Academic/Hospital | 36 | 36 | 5 | 2011 |
| University of Copenhagen | Academic/Hospital | 24 | 21 | 5 | 2001 |
| Allina Health | Academic/Hospital | 23 | 1 | 2 | 2013 |
| Mayo Clinic | Academic/Hospital | 21 | 17 | 5 | 2004 |
| Northwestern University | Academic/Hospital | 21 | 18 | 4 | 2004 |
| Duke University | Academic/Hospital | 19 | 16 | 4 | 2007 |
| University of Sao Paulo | Academic/Hospital | 19 | 19 | 4 | 2004 |
| Harvard University | Academic/Hospital | 18 | 15 | 5 | 2003 |
| Stanford University | Academic/Hospital | 17 | 15 | 5 | 2005 |
| University of Toronto | Academic/Hospital | 17 | 16 | 4 | 2006 |
| Zars Pharma Inc. | For profit | 17 | 16 | 4 | 2005 |
| Endo Pharmaceuticals | For profit | 16 | 11 | 4 | 2002 |
| University of Texas at Houston | Academic/Hospital | 16 | 13 | 5 | 2006 |
| University of California, San Francisco | Academic/Hospital | 15 | 11 | 5 | 2003 |
| Oregon Health and Science University | Academic/Hospital | 14 | 10 | 4 | 2005 |
| Tanta University | Academic/Hospital | 14 | 14 | 2 | 2016 |
| United States Army | Government | 14 | 9 | 5 | 2002 |
| Yonsei University | Academic/Hospital | 14 | 14 | 1 | 2010 |
Marketing (137)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ACP Nimble | For profit | MKTG | Dec 12, 2018 |
| AFAXYS | For profit | MKTG | Jun 9, 2022 |
| Abbott | For profit | NDA2 | Dec 20, 1972 |
| Abbott | For profit | MKTG | Dec 20, 1972 |
| Abraxis | For profit | NDA2 | Feb 15, 1972 |
| Abraxis | For profit | MKTG | Feb 15, 1972 |
| Acrux Ltd | For profit | MKTG | Jul 27, 2021 |
| Actavis | For profit | MKTG | Dec 30, 1992 |
| Actavis | For profit | SYN | May 9, 1980 |
| Akorn, Inc. | For profit | NDA2 | Jul 29, 1976 |
| Akorn, Inc. | For profit | MKTG | Mar 12, 1953 |
| Alembic | For profit | MKTG | Nov 23, 2018 |
| Alembic | For profit | SYN | Nov 23, 2018 |
| Alkem Labs Ltd | For profit | MKTG | Mar 10, 2017 |
| American Home Products | For profit | MKTG | Aug 29, 1975 |
| Amneal Pharmaceuticals | For profit | MKTG | Aug 7, 2015 |
| Amneal Pharmaceuticals | For profit | SYN | Aug 24, 2020 |
| Amphastar Pharmaceuticals | For profit | MKTG | May 23, 2003 |
| Amphastar Pharmaceuticals | For profit | NDA2 | May 23, 2003 |
| Ani Pharmaceuticals | For profit | MKTG | Mar 23, 2022 |
| Aspiro | For profit | MKTG | Nov 8, 2021 |
| Astra | For profit | NDA | — |
| AstraZeneca | For profit | NDA2 | May 17, 1951 |
| Aurobindo Pharma | For profit | MKTG | Mar 14, 2013 |
| B. Braun | For profit | NDA2 | Mar 30, 1984 |
| B. Braun | For profit | MKTG | Aug 3, 2018 |
| Baxalta | For profit | NDA2 | Apr 22, 1981 |
| Baxter | For profit | NDA2 | Apr 22, 1981 |
| Belmar Pharmacy | For profit | MKTG | Dec 3, 1973 |
| Belmora | Academic/Hospital | MKTG | Jun 30, 1971 |
| Bionpharma Inc | For profit | MKTG | Apr 11, 1974 |
| Bionpharma Inc | For profit | SYN | Apr 11, 1974 |
| Bluepharma | For profit | MKTG | Apr 11, 1974 |
| Bristol-Myers Squibb | For profit | MKTG | — |
| Carlisle | For profit | MKTG | Jan 18, 1977 |
| Chartwell Pharmaceuticals | For profit | MKTG | Feb 27, 2007 |
| Cosette | For profit | MKTG | Apr 29, 1993 |
| Daiichi Sankyo | For profit | MKTG | Aug 14, 2015 |
| Del Laboratories | For profit | MKTG | Mar 18, 1975 |
| Dentsply International | For profit | NDA2 | Nov 19, 1948 |
| Dentsply International | For profit | MKTG | Dec 19, 2003 |
| Deproco | For profit | MKTG | Jan 22, 1985 |
| Dr. Reddy's Laboratories | For profit | MKTG | Jan 5, 2021 |
| Elkins Sinn | For profit | MKTG | Apr 30, 1975 |
| Empi | For profit | MKTG | Oct 26, 2004 |
| Empi | For profit | NDA2 | Oct 26, 2004 |
| Encube Ethicals Pvt. Ltd. | For profit | MKTG | Aug 27, 2003 |
| Eugia Pharma | For profit | MKTG | Mar 14, 2013 |
| Fougera | For profit | MKTG | Aug 18, 2003 |
| Fougera | For profit | SYN | Jun 30, 1972 |
| Fresenius | For profit | NDA2 | Nov 19, 1948 |
| Fresenius | For profit | MKTG | Dec 29, 1971 |
| G & W Laboratories Inc. | For profit | MKTG | Dec 12, 2018 |
| G D Searle | For profit | MKTG | Aug 9, 1982 |
| Galen | For profit | MKTG | Jun 23, 2005 |
| Geneyork Pharmaceuticals | For profit | MKTG | Oct 17, 2019 |
| Glenmark Pharmaceuticals | For profit | MKTG | Sep 9, 2016 |
| Hi Tech Pharmaceuticals | For profit | MKTG | Sep 25, 2003 |
| Hikma | For profit | MKTG | Apr 3, 1985 |
| Hikma | For profit | MKTG | Apr 3, 1985 |
| Hisamitsu Pharmaceutical Co., Inc. | For profit | MKTG | Dec 1, 2020 |
| Hospira | For profit | NDA2 | Apr 6, 1972 |
| Hospira | For profit | MKTG | Apr 6, 1972 |
| Huons Co.,Ltd. | For profit | MKTG | May 7, 2020 |
| IBSA Institut Biochimique SA | For profit | MKTG | Apr 30, 2020 |
| International Medication | For profit | NDA2 | Sep 17, 1975 |
| International Medication | For profit | MKTG | Sep 17, 1975 |
| Kendall McGaw Laboratories | For profit | MKTG | Jun 10, 1983 |
| Kodak | For profit | MKTG | Feb 26, 1993 |
| Lannett Company, Inc. | For profit | MKTG | Feb 27, 2007 |
| Lutipold | For profit | MKTG | Jun 23, 1972 |
| Lyphomed, Inc. | For profit | MKTG | Mar 14, 1977 |
| Macleods Pharmaceuticals, Ltd | For profit | MKTG | Mar 16, 2020 |
| Mankind Pharma | For profit | MKTG | Jun 16, 2023 |
| Merck | For profit | MKTG | Jul 11, 1962 |
| Merck | For profit | NDA2 | Jul 11, 1962 |
| Meridien Medical Technologies, Inc. | For profit | NDA2 | Mar 28, 1975 |
| Miles | For profit | MKTG | — |
| Mylan | For profit | MKTG | Aug 7, 2015 |
| Mylan | For profit | SYN | Sep 27, 2010 |
| NAL Pharmaceuticals | For profit | MKTG | Apr 29, 2021 |
| Neogen | For profit | MKTG | Mar 16, 2020 |
| Novartis | For profit | NDA2 | — |
| Novast Labs | For profit | MKTG | Sep 20, 2017 |
| Noven Therapeutics | For profit | MKTG | Dec 1, 2020 |
| Noven Therapeutics | For profit | NDA2 | May 21, 1996 |
| Novitium Pharma | For profit | MKTG | Mar 23, 2022 |
| Paco | For profit | MKTG | Jun 30, 1989 |
| Padagis Us | For profit | MKTG | Jul 27, 2021 |
| Pfizer | For profit | MKTG | Sep 15, 1964 |
| Pharmaceutical Associates | For profit | MKTG | Mar 12, 2014 |
| Pharmaton | For profit | MKTG | Aug 17, 1983 |
| Powder Pharmaceuticals | For profit | NDA2 | Aug 16, 2007 |
| Praxgen Pharma | For profit | MKTG | Oct 17, 2019 |
| Quagen Pharma | For profit | MKTG | Apr 20, 2021 |
| R.P. Scherer | For profit | MKTG | Jun 30, 1989 |
| Rhodes Pharmaceuticals, L.P. | For profit | MKTG | Apr 30, 2020 |
| RiconPharma | For profit | MKTG | Sep 20, 2017 |
| Rising Pharmaceuticals | For profit | SYN | Apr 11, 2014 |
| Rising Pharmaceuticals | For profit | MKTG | Sep 20, 2017 |
| Roche | For profit | MKTG | Dec 21, 1984 |
| Roche | For profit | NDA2 | Dec 21, 1984 |
| Rubicon Research | For profit | MKTG | Mar 28, 2023 |
| SENTISS | For profit | MKTG | Feb 12, 2003 |
| Sagent Pharmaceuticals, Inc. | For profit | SYN | Apr 28, 2014 |
| Sagent Pharmaceuticals, Inc. | For profit | MKTG | Apr 28, 2014 |
| Sankyo | For profit | MKTG | Jun 23, 1972 |
| Scilex Pharms Inc | For profit | NDA2 | Feb 28, 2018 |
| Scilex Pharms Inc | For profit | MKTG | Feb 28, 2018 |
| Septodont | For profit | SYN | Sep 9, 1980 |
| Septodont | For profit | MKTG | May 23, 2011 |
| Sintetica SA | For profit | MKTG | May 5, 2022 |
| Sorrento Therapeutics, Inc. | For profit | NDA2 | Feb 28, 2018 |
| Spectra Medical Devices | For profit | MKTG | Apr 18, 2018 |
| Strides Pharma Science | For profit | MKTG | Dec 11, 2018 |
| Taro Pharmaceuticals | For profit | MKTG | Aug 17, 1981 |
| Taro Pharmaceuticals | For profit | SYN | Jun 29, 2006 |
| Taro Pharmaceuticals | For profit | NDA2 | Jun 29, 2006 |
| Teikoku Pharma USA, Inc. | For profit | NDA2 | Mar 19, 1999 |
| Teligent Pharmaceuticals | For profit | SYN | Mar 12, 2014 |
| Teligent Pharmaceuticals | For profit | MKTG | Feb 1, 2016 |
| Teva | For profit | MKTG | Jan 16, 2018 |
| Teva | For profit | SYN | Dec 30, 1992 |
| Teva | For profit | NDA2 | Dec 30, 1992 |
| Thea Pharma | For profit | MKTG | Oct 7, 2008 |
| Thea Pharma | For profit | NDA2 | Oct 7, 2008 |
| Tolmar Inc. | For profit | MKTG | Aug 27, 2003 |
| Vitruvias Therapeutics | For profit | MKTG | Sep 25, 2017 |
| Vyteris | For profit | MKTG | May 6, 2004 |
| Vyteris | For profit | NDA2 | May 6, 2004 |
| Warner Chilcott | For profit | NDA2 | Jun 23, 2005 |
| Watson Pharmaceuticals | For profit | MKTG | Feb 20, 1974 |
| Watson Pharmaceuticals | For profit | SYN | Mar 23, 2011 |
| West-Ward Pharmaceutical | For profit | MKTG | Feb 14, 1972 |
| Wockhardt | For profit | MKTG | Nov 18, 1982 |
| iOMEDICO AG | For profit | MKTG | Dec 21, 1995 |
| iOMEDICO AG | For profit | NDA2 | Dec 21, 1995 |