acetaminophen
Trade name: tylenol
Approved
Jun 1, 1950
Acetaminophen, also known as paracetamol, is commonly used for its analgesic and antipyretic effects. Its therapeutic effects are similar to salicylates, but it lacks anti-inflammatory, antiplatelet, and gastric ulcerative effects. Acetaminophen (USAN) or Paracetamol (INN) is a widely used analgesic and antipyretic drug that is used for the relief of fever, headaches, and other minor aches and pains. It is a major ingredient in numerous cold and flu medications and many prescription analgesics. It is extremely safe in standard doses, but because of its wide availability, deliberate or accidental overdoses are not uncommon. Acetaminophen, unlike other common analgesics such as aspirin and ibuprofen, has no anti-inflammatory properties or effects on platelet function, and it is not a member of the class of drugs known as non-steroidal anti-inflammatory drugs or NSAIDs. At therapeutic doses, acetaminophen does not irritate the lining of the stomach nor affect blood coagulation, kidney function, or the fetal ductus arteriosus (as NSAIDs can). Acetaminophen is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Unlike NSAIDs, acetaminophen does not inhibit cyclooxygenase in peripheral tissues and, thus, has no peripheral anti-inflammatory affects. Acetaminophen indirectly blocks COX, and that this blockade is ineffective in the presence of peroxides. This might explain why acetaminophen is effective in the central nervous system and in endothelial cells but not in platelets and immune cells, which have high levels of peroxides. Studies also report data suggesting that acetaminophen selectively blocks a variant of the COX enzyme that is different from the known variants COX-1 and COX-2. This enzyme is now referred to as COX-3. Its exact mechanism of action is still poorly understood, but future research may provide further insight into how it works. The antipyretic properties of acetaminophen are likely due to direct effects on the heat-regulating centers of the hypothalamus resulting in peripheral vasodilation, sweating and hence heat dissipation. — NCATS
Clinical trial activity
1,256 trials · 788 clinical orgs · 155 marketing orgs
Earliest trial started Sep 1, 1994 (NCT00429624)
Timeline
1950s
- Jun 1, 1950
Earliest FDA Approval
1960s
- Nov 7, 1968
Polymedica — NDA Secondary Org
1970s
- Oct 18, 1972
AAIPharma — Marketing Organization
- Oct 18, 1972
AAIPharma — NDA Secondary Org
- Dec 19, 1972
Xanodyne Pharmaceuticals — Marketing Organization
- Dec 19, 1972
Xanodyne Pharmaceuticals — NDA Secondary Org
- May 31, 1974
Carnrick Laboratories — Marketing Organization
- Oct 25, 1974
Mylan — Marketing Organization
- Jul 22, 1975
AH Robins — Marketing Organization
- May 10, 1976
Roxane Laboratories — Marketing Organization
- May 26, 1976
Johnson and Johnson — NDA Secondary Org
- Jul 9, 1976
Johnson and Johnson — Marketing Organization
- Sep 3, 1976
Caraco Pharmaceutical Laboratories — Marketing Organization
- Feb 10, 1977
Sandoz — Marketing Organization
- Aug 23, 1977
Lumara Health — Marketing Organization
- Oct 25, 1977
Bristol-Myers Squibb — Marketing Organization
- Dec 19, 1977
Whiteworth Towne Paulsen — Marketing Organization
- Jan 20, 1978
Mutual Pharmaceutical — Marketing Organization
- Feb 9, 1978
ACP Nimble — NDA Secondary Org
- Feb 9, 1978
Cosette — Marketing Organization
- Feb 9, 1978
Cosette — NDA Secondary Org
- Mar 14, 1978
Warner Chilcott — Marketing Organization
- Mar 17, 1978
Everylife Foundation for Rare Diseases — Marketing Organization
- May 10, 1978
R.P. Scherer — Marketing Organization
- Nov 6, 1978
Sun Pharmaceuticals — Marketing Organization
- Mar 27, 1979
ACI Limited — Marketing Organization
1980s
- Feb 25, 1980
West-Ward Pharmaceutical — Marketing Organization
- Apr 22, 1980
Taro Pharmaceuticals — NDA Secondary Org
- Apr 22, 1980
Taro Pharmaceuticals — Marketing Organization
- Aug 21, 1981
Pharmaceutical Associates — Marketing Organization
- Nov 2, 1981
Barr Laboratories — Marketing Organization
- May 3, 1982
Ascher — Marketing Organization
- May 3, 1982
UCB — Marketing Organization
- May 26, 1982
Watson Pharmaceuticals — Marketing Organization
- Jul 8, 1982
Avon Products — Marketing Organization
- Sep 23, 1982
Sanofi-Aventis — Marketing Organization
- Sep 23, 1982
Sanofi-Aventis — NDA Secondary Org
- Nov 3, 1982
Lederle — Marketing Organization
- Nov 3, 1982
American Cyanamid — Marketing Organization
- Dec 10, 1982
Puracap Pharmaceutical — Marketing Organization
- Jan 7, 1983
AbbVie — Marketing Organization
- Mar 17, 1983
Forest Laboratories — Marketing Organization
- Dec 7, 1983
Specgx Llc — Marketing Organization
- Dec 29, 1983
Teva — Marketing Organization
- Feb 6, 1984
Duramed Research — Marketing Organization
- Mar 20, 1984
Vanguard — Marketing Organization
- May 25, 1984
Abbott — Marketing Organization
- Mar 27, 1985
Century Pharmaceuticals — Marketing Organization
- Mar 27, 1985
Graham Dm — Marketing Organization
- Jun 19, 1985
Bausch Health Companies — Marketing Organization
- Oct 17, 1985
Mayrand — Marketing Organization
- Oct 18, 1985
Superpharm — Marketing Organization
- Feb 21, 1986
Mikart — Marketing Organization
- Mar 4, 1986
Pharmaceutical Research Associates, Inc. (PRA) — Marketing Organization
- Mar 17, 1986
Mayne Pharma — Marketing Organization
- Mar 17, 1986
Dr. Reddy's Laboratories — Marketing Organization
- May 14, 1986
Leitner Pharms — Marketing Organization
- May 15, 1986
Abana — Marketing Organization
- Oct 1, 1986
Shire — Marketing Organization
- Jan 2, 1987
Actavis — Marketing Organization
- Mar 3, 1987
Am Therap — Marketing Organization
- Apr 23, 1987
International Minerals and Chemical Corporation — Marketing Organization
- May 12, 1987
Acino — Marketing Organization
- May 22, 1987
Schering-Plough — Marketing Organization
- May 22, 1987
Schering-Plough — NDA Secondary Org
- Jul 2, 1987
Dunhall Pharmaceuticals — Marketing Organization
- Feb 10, 1988
Rhodes Pharmaceuticals, L.P. — Marketing Organization
- Apr 21, 1988
Ivax — Marketing Organization
- May 13, 1988
Halsey — Marketing Organization
- Sep 30, 1988
Vintage — Marketing Organization
- Jan 12, 1989
Boehringer Ingelheim — Marketing Organization
1990s
- Mar 27, 1992
G & W Laboratories Inc. — Marketing Organization
- Jul 16, 1992
Fosun — Marketing Organization
- Jul 30, 1992
Actavis — NDA Secondary Org
- Oct 27, 1992
ANDA Repository — Marketing Organization
- Jan 1, 1996
Earliest Phase 3 Sponsor(trial)
- Apr 26, 1996
Hi Tech Pharmaceuticals — Marketing Organization
- Apr 26, 1996
Akorn, Inc. — Marketing Organization
- Sep 20, 1996
DAVA Pharmaceuticals — Marketing Organization
- Jan 1, 1997
Earliest Phase 2 Sponsor(trial)
- Feb 14, 1997
Allergan — Marketing Organization
- Feb 14, 1997
SmithKline Beecham — Marketing Organization
- Jan 1, 1998
Earliest Phase 1 Sponsor(trial)
- Jan 14, 1998
GlaxoSmithKline — Marketing Organization
2000s
- Feb 25, 2000
Perrigo — Marketing Organization
- Mar 1, 2001
Novartis — Marketing Organization
- Mar 1, 2001
Novartis — NDA Secondary Org
- Mar 23, 2001
Hikma — Marketing Organization
- Jul 11, 2001
Able Laboratories — Marketing Organization
- Jan 23, 2002
Nesher Pharms — Marketing Organization
- Mar 19, 2002
Ohm Laboratories, Inc. — Marketing Organization
- Aug 2, 2002
Gavis Pharmaceuticals — Marketing Organization
- Aug 29, 2003
Mallinckrodt — Marketing Organization
- May 7, 2004
Rafael Pharmaceuticals Inc. — Marketing Organization
- Jun 10, 2004
LGM Pharma — Marketing Organization
- Apr 21, 2005
Par Pharmaceuticals — Marketing Organization
- Jul 26, 2006
Shijiazhuang Pharma Group (CSPC) — Marketing Organization
- Jul 26, 2006
Graviti Pharmaceuticals — Marketing Organization
- Jul 26, 2006
Rising Pharmaceuticals — Marketing Organization
- Mar 16, 2007
Wockhardt — Marketing Organization
- Apr 3, 2007
Boca Pharmacal — Marketing Organization
- Apr 3, 2007
Wraser Pharmaceuticals — Marketing Organization
- Aug 16, 2007
Ranbaxy — Marketing Organization
- Nov 27, 2007
Amneal Pharmaceuticals — Marketing Organization
- Feb 11, 2008
Mirror Pharms — Marketing Organization
- Dec 1, 2008
Novast Labs — Marketing Organization
- Nov 16, 2009
Nexgen Pharma, Inc — Marketing Organization
2010s
- Nov 2, 2010
International Minerals and Chemical Corporation — NDA Secondary Org
- Jan 24, 2011
Apax Partners — Marketing Organization
- Jul 19, 2011
Genus Oncology, LLC — Marketing Organization
- Nov 10, 2011
Lannett Company, Inc. — Marketing Organization
- Jan 25, 2012
VistaPharm, Inc. — Marketing Organization
- Mar 30, 2012
Alkem Labs Ltd — Marketing Organization
- Jul 26, 2012
Alvogen — Marketing Organization
- Sep 6, 2012
Zydus Discovery DMCC — Marketing Organization
- Dec 14, 2012
Micro Labs Ltd India — Marketing Organization
- Mar 27, 2013
Tris Pharma, Inc. — Marketing Organization
- Apr 7, 2014
Apotex — Marketing Organization
- Oct 28, 2015
Fresenius — NDA Secondary Org
- Oct 30, 2015
County Line — Marketing Organization
- Dec 4, 2015
Larken Labs Inc — Marketing Organization
- Apr 14, 2016
Cypress Pharmaceutical — Marketing Organization
- Apr 14, 2016
Pernix — Marketing Organization
- Jun 2, 2016
Allergan PLC (2015) — Marketing Organization
- Jun 13, 2016
Custopharm Inc — Marketing Organization
- Oct 28, 2016
Nuvo Research Inc. — Marketing Organization
- Nov 9, 2016
Aurobindo Pharma — Marketing Organization
- Nov 14, 2016
Novel Anti-Infective Technologies, LLC — Marketing Organization
- Dec 13, 2016
Exeltis — Marketing Organization
- Dec 13, 2016
Cerovene — Marketing Organization
- Mar 22, 2017
Ascent Pharmahealth — Marketing Organization
- Mar 24, 2017
Upsher-Smith Laboratories — Marketing Organization
- May 2, 2017
Macleods Pharmaceuticals, Ltd — Marketing Organization
- May 2, 2017
Neogen — Marketing Organization
- Jun 21, 2017
Abhai LLC — Marketing Organization
- Aug 4, 2017
Xspire Pharma — Marketing Organization
- Oct 30, 2017
Wes Pharma Inc — Marketing Organization
- Dec 14, 2017
Aclaris Therapeutics, Inc. — NDA Secondary Org
- Feb 23, 2018
Kvk Tech Inc — Marketing Organization
- Feb 23, 2018
Zevra Therapeutics — NDA Secondary Org
- Mar 30, 2018
Epic Pharma Llc — Marketing Organization
- May 31, 2018
Heritage Pharma — Marketing Organization
- May 31, 2018
Emcure — Marketing Organization
- Jul 2, 2018
Elite Laboratories, Inc — Marketing Organization
- Jul 2, 2018
Nostrum Laboratories — Marketing Organization
- Nov 27, 2018
Nautic Partners — Marketing Organization
- Apr 16, 2019
Granules India — Marketing Organization
- Jun 27, 2019
Eywa Pharma — Marketing Organization
- Aug 15, 2019
Chartwell Pharmaceuticals — Marketing Organization
2020s
- Feb 28, 2020
Pfizer — NDA Secondary Org
- Feb 28, 2020
GlaxoSmithKline — NDA Secondary Org
- Jul 8, 2020
Strides Pharma Science — Marketing Organization
- Oct 21, 2020
Eugia Pharma — Marketing Organization
- Jan 15, 2021
Rising Pharmaceuticals — NDA Secondary Org
- Feb 18, 2021
B. Braun — Marketing Organization
- Feb 18, 2021
B. Braun — NDA Secondary Org
- Aug 13, 2021
Senores Pharms — Marketing Organization
- Aug 25, 2021
Marksans Pharma — Marketing Organization
- Sep 17, 2021
Baxalta — Marketing Organization
- Sep 17, 2021
Takeda — Marketing Organization
- Nov 17, 2021
RiconPharma — Marketing Organization
- Dec 30, 2021
Prinston Inc — Marketing Organization
- Jun 3, 2022
Hikma — NDA Secondary Org
- Jul 27, 2022
Aspiro — Marketing Organization
- Aug 16, 2022
AACE PHARMS — Marketing Organization
- Mar 1, 2023
AFT PHARMS LTD — NDA Secondary Org
- May 3, 2023
Hq Speciality Pharma — Marketing Organization
- Aug 1, 2023
Bionpharma Inc — Marketing Organization
Indications
Approved for
Studied for
- Abdomen, Acute · Phase 3
- Abdominal Pain · Phase 3
- Abortion, Induced · Phase 4
- Acetaminophen · Phase 4
- Acupressure · Phase 1
- Acute Coronary Syndrome · Phase 4
- Acute Kidney Injury · Phase 3
- Acute Pain · Phase 4
- Adenoidectomy · Phase 4
- Adenoids · Phase 2
- Administration, Intranasal · Phase 3
- Administration, Oral · Phase 1
- Aged · Phase 4
- Airway Obstruction · Phase 4
- Alcoholism · Phase 4
- Alcohol-Related Disorders · Phase 4
- Allergy and Immunology · Phase 3
- alpha 1-Antitrypsin Deficiency · Phase 1
- Alzheimer Disease · Phase 4
- Ambulatory Surgical Procedures · Phase 3
- Analgesia · Phase 4
- Analgesia, Epidural · Phase 4
- Analgesia, Obstetrical · Phase 2
- Analgesia, Patient-Controlled · Phase 4
- Analgesics · Phase 4
- Analgesics, Non-Narcotic · Phase 1
- Analgesics, Opioid · Phase 4
- Anemia, Sickle Cell · Phase 4
- Anesthesia · Phase 4
- Anesthesia and Analgesia · Phase 4
- Anesthesia, General · Phase 3
- Anesthesia, Local · Phase 4
- Anesthesia Recovery Period · Phase 4
- Anesthesia, Spinal · Phase 4
- Anesthetics, Local · Phase 4
- Ankle Fractures · Early Phase 1
- Ankle Injuries · Phase 4
- Anterior Cruciate Ligament Injuries · Phase 3
- Anterior Cruciate Ligament Reconstruction · Phase 4
- Anti-Inflammatory Agents, Non-Steroidal · Phase 4
- Antiphospholipid Syndrome · Phase 4
- Anxiety · Phase 2/Phase 3
- Aortic Aneurysm, Abdominal · Phase 3
- Appendicitis · Phase 1/Phase 2
- Arnold-Chiari Malformation · Phase 2
- Arrhythmias, Cardiac · Phase 1/Phase 2
- Arteries · Phase 2/Phase 3
- Arthralgia · Phase 4
- Arthritis · Phase 4
- Arthritis, Rheumatoid · Phase 4
- Arthropathy, Neurogenic · Phase 4
- Arthroplasty · Phase 4
- Arthroplasty, Replacement, Hip · Phase 4
- Arthroplasty, Replacement, Knee · Phase 3
- Arthroscopy · Phase 4
- Asthma · Phase 4
- Atrial Fibrillation · Phase 4
- Automobile Driving · Phase 4
- Back Pain · Phase 4
- Balanitis · Phase 2
- Bariatric Surgery · Phase 4
- Behavior · Phase 2
- Blood Pressure · Phase 4
- Blood Protein Disorders · Phase 2
- Body Temperature · Phase 2/Phase 3
- Body Weight Changes · Phase 4
- Borderline Personality Disorder · Phase 2
- Brachial Plexus Block · Phase 3
- Brain Concussion · Phase 2
- Brain Injuries · Phase 4
- Brain Injuries, Traumatic · Phase 4
- Breast Diseases · Phase 3
- Breast Neoplasms · Phase 4
- Breech Presentation · Phase 3
- Bronchopulmonary Dysplasia · Phase 2
- Bunion · Phase 3
- Caffeine · Phase 3
- Cancer Pain · Phase 4
- Carcinoma, Intraductal, Noninfiltrating · Phase 4
- Carcinoma, Non-Small-Cell Lung · Phase 3
- Carotid Artery Diseases · Phase 4
- Carpal Tunnel Syndrome · Phase 4
- Catheters · Phase 4
- Celiac Disease · Phase 4
- Central Nervous System Diseases · Phase 1
- Cerebral Hemorrhage · Phase 1/Phase 2
- Cerebral Palsy · Phase 4
- Cervix Uteri · Phase 4
- Cesarean Section · Phase 4
- Chemical and Drug Induced Liver Injury · Phase 4
- Child · Phase 4
- Cholecystectomy · Phase 3
- Cholecystectomy, Laparoscopic · Phase 4
- Cholecystitis · Phase 4
- Cholelithiasis · Phase 4
- Chorioamnionitis · Phase 4
- Chronic Pain · Phase 4
- Circumcision, Male · Phase 4
- Cleft Palate · Phase 2
- Cognition · Phase 1/Phase 2
- Cognition Disorders · Phase 2
- Cognitive Aging · Phase 3
- Cognitive Dysfunction · Phase 4
- Cold Temperature · Phase 3
- Colonic Neoplasms · Phase 4
- Colorectal Surgery · Phase 4
- Coma · Phase 2
- Common Cold · Phase 4
- Communication · Phase 2
- Conjunctivitis · Phase 3
- Consciousness Disorders · Phase 2
- Constipation · Phase 4
- Corneal Diseases · Phase 1
- Coronary Artery Disease · Phase 4
- Coronavirus · Phase 3
- COVID-19 · Phase 3
- Craniotomy · Phase 4
- Critical Illness · Phase 4
- Crohn Disease · Phase 1/Phase 2
- Cystectomy · Phase 4
- Delirium · Phase 4
- Dementia · Phase 4
- Dementia, Vascular · Phase 4
- Dental Implantation, Endosseous · Phase 4
- Dental Implants · Phase 4
- Dentin Sensitivity · Phase 4
- Depression · Phase 4
- De Quervain Disease · Phase 4
- Dexmedetomidine · Phase 3
- Diabetes Mellitus · Phase 1
- Diabetes Mellitus, Type 1 · Phase 2
- Diabetes Mellitus, Type 2 · Phase 4
- Diabetic Neuropathies · Phase 4
- Diverticulitis · Phase 4
- Diverticulitis, Colonic · Phase 4
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Drugs, Generic · Phase 1
- Dry Eye Syndromes · Phase 1
- Ductus Arteriosus, Patent · Phase 4
- Dysmenorrhea · Phase 4
- Eclampsia · Phase 4
- Electroconvulsive Therapy · Phase 2
- Emergence Delirium · Phase 4
- Emergency Medicine · Phase 4
- Empathy · Phase 1
- Endothelium · Phase 4
- Enhanced Recovery After Surgery · Phase 1
- Ependymoma · Phase 2
- Epilepsy · Phase 2
- Fabry Disease · Phase 4
- Facial Pain · Early Phase 1
- Fallopian Tube Neoplasms · Phase 3
- Fascia · Phase 4
- Fasting · Phase 4
- Femoral Fractures · Phase 4
- Fetal Development · Phase 1
- Fever · Phase 4
- Fibromyalgia · Phase 4
- Flank Pain · Phase 4
- Fractures, Bone · Phase 4
- Gabapentin · Phase 3
- Gallstones · Phase 4
- Ganglion Cysts · Phase 4
- Gastric Emptying · Phase 4
- Gastroenterology · Phase 4
- Gastrointestinal Diseases · Phase 2
- General Surgery · Phase 4
- Gingival Diseases · Phase 2
- Gingival Recession · Phase 4
- Glaucoma · Early Phase 1
- Glycogen Storage Disease Type II · Phase 1
- Graft Rejection · Phase 2
- Graft vs Host Disease · Phase 2
- Hamartoma · Phase 4
- Hand, Foot and Mouth Disease · Phase 2
- Headache · Phase 4
- Headache Disorders · Phase 1
- Head and Neck Neoplasms · Phase 2
- Healthy Volunteers · Phase 4
- Heart Diseases · Phase 3
- Heart Rate · Phase 1/Phase 2
- HELLP Syndrome · Phase 4
- Hematologic Diseases · Phase 2
- Hematoma, Subdural · Phase 1/Phase 2
- Hemorrhage · Phase 4
- Hepatitis · Phase 1
- Hernia · Phase 3
- Hernia, Abdominal · Phase 4
- Hernia, Inguinal · Phase 4
- Herpangina · Phase 2
- Hip Fractures · Phase 4
- HIV Infections · Phase 3
- Hodgkin Disease · Phase 2
- Homocystinuria · Phase 1/Phase 2
- Hospital Costs · Phase 4
- Humans · Phase 4
- Hyperalgesia · Phase 4
- Hyperopia · Phase 2
- Hyperplasia · Phase 4
- Hypertension · Phase 4
- Hypertension, Pregnancy-Induced · Phase 4
- Hypertrophy, Left Ventricular · Phase 3
- Hysterectomy · Phase 4
- Ibuprofen · Phase 4
- Ileus · Phase 4
- Immune System Diseases · Phase 4
- Immunization · Phase 1/Phase 2
- Immunoglobulin G4-Related Disease · Phase 2
- Infant · Phase 1
- Infant, Newborn · Phase 1
- Infant, Premature · Phase 4
- Infant, Premature, Diseases · Phase 2/Phase 3
- Infections · Phase 2/Phase 3
- Inflammation · Early Phase 1
- Influenza A virus · Phase 3
- Influenza, Human · Phase 4
- Infratentorial Neoplasms · Phase 3
- Intervertebral Disc Degeneration · Phase 1
- Intestinal Diseases · Phase 4
- Intestinal Neoplasms · Phase 4
- Intestinal Pseudo-Obstruction · Phase 4
- Ischemic Attack, Transient · Phase 3
- Ischemic Stroke · Phase 1/Phase 2
- Joint Diseases · Phase 3
- Ketamine · Phase 3
- Ketorolac · Phase 3
- Kidney Calculi · Phase 4
- Kidney Diseases · Phase 3
- Kidney Failure, Chronic · Phase 2
- Kidney Neoplasms · Phase 2
- Kidney Transplantation · Phase 2
- Knee Injuries · Phase 4
- Labor Pain · Phase 4
- Laparoscopy · Phase 3
- Length of Stay · Phase 4
- Leukemia · Phase 2
- Leukemia, Hairy Cell · Phase 1
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 2
- Leukemia, Myeloid, Acute · Phase 2
- Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative · Phase 1
- Leukemia, Myeloid, Chronic-Phase · Phase 1/Phase 2
- Lidocaine · Phase 3
- Ligaments · Phase 4
- Limb Deformities, Congenital · Phase 4
- Live Birth · Phase 1/Phase 2
- Liver Cirrhosis · Phase 1
- Liver Transplantation · Phase 1/Phase 2
- Low Back Pain · Phase 4
- Lung Neoplasms · Phase 4
- Lupus Erythematosus, Systemic · Phase 3
- Lupus Nephritis · Phase 3
- Lyme Disease · Phase 3
- Lymphoma · Phase 3
- Lymphoma, Follicular · Phase 2
- Lymphoma, Large B-Cell, Diffuse · Phase 2
- Lymphoma, Large-Cell, Immunoblastic · Phase 2
- Lymphoma, Non-Hodgkin · Phase 3
- Magnetic Resonance Imaging · Phase 1
- Malaria · Phase 4
- Malaria, Falciparum · Phase 4
- Mastectomy · Phase 4
- Mastocytosis, Systemic · Phase 1
- Mastodynia · Phase 4
- Medulloblastoma · Phase 2
- Melanoma · Phase 3
- Meningitis, Bacterial · Phase 4
- Meningococcal Vaccines · Phase 2
- Meniscus · Early Phase 1
- Mental Disorders · Phase 4
- Metabolic Side Effects of Drugs and Substances · Early Phase 1
- Migraine Disorders · Phase 4
- Migraine with Aura · Phase 4
- Migraine without Aura · Phase 2
- Mitral Valve · Phase 4
- Mobility Limitation · Phase 4
- Molar, Third · Early Phase 1
- Morphine · Phase 4
- Mucositis · Phase 3
- Multiple Myeloma · Phase 4
- Multiple Sclerosis · Phase 4
- Multiple Sclerosis, Chronic Progressive · Phase 3
- Multiple Sclerosis, Relapsing-Remitting · Phase 4
- Multiple Trauma · Phase 3
- Muscle Weakness · Phase 2/Phase 3
- Musculoskeletal Diseases · Phase 4
- Musculoskeletal Pain · Phase 4
- Myelodysplastic Syndromes · Phase 2
- Myocardial Infarction · Phase 4
- Myopia · Phase 4
- Nail Diseases · Phase 4
- Nails, Malformed · Phase 4
- Narcotics · Phase 4
- Nasal Obstruction · Phase 4
- Nasolabial Fold · Phase 1
- Nausea · Phase 4
- Neck Pain · Phase 4
- Neoplasm Metastasis · Phase 3
- Neoplasms · Phase 4
- Neoplasms by Histologic Type · Phase 2
- Neoplasms, Plasma Cell · Phase 2
- Nephrectomy · Phase 4
- Nephrolithiasis · Phase 3
- Nephrolithotomy, Percutaneous · Phase 4
- Nerve Block · Phase 4
- Neuralgia · Phase 4
- Neurofibroma · Phase 1
- Nocturia · Phase 2
- Non-alcoholic Fatty Liver Disease · Phase 2
- Obesity · Phase 4
- Obesity, Morbid · Phase 4
- Obstetrics · Phase 2
- Oocyte Retrieval · Phase 4
- Opiate Substitution Treatment · Phase 4
- Opioid-Related Disorders · Phase 4
- Oral Hemorrhage · Phase 4
- Orthopedic Procedures · Phase 4
- Osteoarthritis · Phase 4
- Osteoarthritis, Hip · Phase 3
- Osteoarthritis, Knee · Phase 4
- Osteoporosis · Phase 4
- Otorhinolaryngologic Diseases · Phase 4
- Ovarian Neoplasms · Phase 3
- Overweight · Phase 1
- Oxidative Stress · Phase 2
- Oximetry · Phase 3
- Paget Disease, Extramammary · Phase 3
- Pain · Phase 4
- Pain Management · Phase 4
- Pain Measurement · Phase 4
- Palliative Care · Phase 2/Phase 3
- Pancreatic Diseases · Phase 4
- Pancreatitis · Phase 4
- Paraphimosis · Phase 2
- Paraproteinemias · Phase 2
- Parasitemia · Phase 2
- Parathyroid Diseases · Phase 4
- Parathyroid Neoplasms · Phase 4
- Parkinson Disease · Phase 1
- Parotid Gland · Phase 2
- Patellofemoral Pain Syndrome · Phase 4
- Pathologic Processes · Phase 3
- Patient Satisfaction · Phase 4
- Pediatric Obesity · Phase 3
- Pediatrics · Phase 4
- Pelvic Organ Prolapse · Phase 4
- Pelvic Pain · Phase 4
- Pemphigus · Phase 3
- Perineum · Phase 2
- Peripheral Arterial Disease · Phase 2
- Peripheral Vascular Diseases · Phase 3
- Persistent Vegetative State · Phase 2
- Pharmacokinetics · Phase 3
- Pharmacology · Phase 2
- Pharyngitis · Phase 4
- Phimosis · Phase 2
- Photorefractive Keratectomy · Phase 2
- Plasmacytoma · Phase 1
- Pneumococcal Vaccines · Phase 4
- Pneumonia, Bacterial · Phase 3
- Pneumothorax · Phase 1/Phase 2
- Post-Concussion Syndrome · Early Phase 1
- Post-Dural Puncture Headache · Phase 4
- Postoperative Complications · Phase 4
- Postoperative Hemorrhage · Phase 4
- Postoperative Nausea and Vomiting · Phase 4
- Postoperative Pain · Phase 4
- Postpartum Period · Phase 1/Phase 2
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma · Phase 1
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 2
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma · Phase 2
- Pre-Eclampsia · Phase 4
- Pregnancy · Phase 3
- Pregnancy Complications · Phase 4
- Pregnancy Trimester, First · Phase 4
- Procedural Sedation · Phase 3
- Prolotherapy · Early Phase 1
- Prostatectomy · Phase 4
- Prostatic Hyperplasia · Phase 3
- Prostatic Neoplasms · Phase 2/Phase 3
- Pruritus · Phase 1/Phase 2
- Pulmonary Embolism · Phase 4
- Pulpitis · Phase 2
- Purpura, Thrombocytopenic, Idiopathic · Phase 1
- Quality of Life · Phase 4
- Radiation Oncology · Phase 3
- Radiculopathy · Phase 2
- Recovery of Function · Phase 4
- Rectal Neoplasms · Phase 4
- Refractive Errors · Phase 4
- Renal Colic · Phase 4
- Respiration, Artificial · Phase 3
- Respiratory Distress Syndrome · Phase 2/Phase 3
- Respiratory Insufficiency · Phase 3
- Respiratory Sounds · Phase 3
- Respiratory Tract Infections · Phase 4
- Rheumatic Diseases · Phase 4
- Rhinitis, Allergic, Seasonal · Phase 4
- Rhinorrhea · Phase 3
- Rhytidoplasty · Phase 1
- Rib Fractures · Phase 4
- Robotic Surgical Procedures · Phase 4
- Rotator Cuff Injuries · Phase 4
- Rotavirus Infections · Phase 3
- SARS-CoV-2 · Phase 2/Phase 3
- Sciatica · Phase 4
- Scoliosis · Phase 3
- Seizures · Phase 4
- Sensitivity and Specificity · Phase 4
- Sepsis · Phase 4
- Shivering · Phase 4
- Shock, Septic · Phase 4
- Shoulder · Phase 4
- Shoulder Pain · Phase 4
- Sinusitis · Phase 4
- Skin Neoplasms · Phase 4
- Sleep Apnea, Obstructive · Phase 4
- Sleep Apnea Syndromes · Phase 4
- Sneezing · Phase 3
- Soft Tissue Injuries · Phase 2
- Spinal Diseases · Phase 3
- Spinal Fusion · Phase 4
- Spinal Injuries · Phase 4
- Spinal Stenosis · Phase 4
- Spondylitis, Ankylosing · Phase 4
- Spondylolisthesis · Phase 1
- Sprains and Strains · Phase 4
- Squamous Cell Carcinoma of Head and Neck · Phase 3
- ST Elevation Myocardial Infarction · Phase 4
- Stomach Diseases · Phase 4
- Stomach Ulcer · Phase 3
- Strabismus · Phase 2
- Streptococcal Infections · Phase 4
- Stroke · Phase 4
- Subarachnoid Hemorrhage · Phase 4
- Substance-Related Disorders · Phase 4
- Surgery, Oral · Phase 4
- Surgical Wound · Phase 4
- Swallows · Phase 4
- Temporomandibular Joint Disorders · Phase 4
- Tension-Type Headache · Phase 2/Phase 3
- Therapeutic Equivalency · Phase 1
- Thoracic Surgery · Phase 2
- Thoracic Surgery, Video-Assisted · Phase 4
- Thyroid Diseases · Phase 4
- Thyroid Gland · Phase 4
- Thyroid Neoplasms · Phase 4
- Thyroid Nodule · Phase 4
- Tibial Meniscus Injuries · Phase 3
- Tonsillectomy · Phase 4
- Tonsillitis · Phase 4
- Tooth · Phase 2
- Tooth Abnormalities · Phase 4
- Toothache · Phase 4
- Tooth Bleaching · Phase 4
- Tooth Extraction · Phase 2/Phase 3
- Tooth Loss · Phase 4
- Tooth Socket · Phase 4
- Transgender Persons · Phase 4
- Trigger Finger Disorder · Phase 4
- Tuberculosis · Phase 4
- Ultrasonography · Phase 4
- Urethral Stricture · Phase 4
- Urinary Bladder, Overactive · Phase 4
- Urinary Calculi · Phase 4
- Urolithiasis · Phase 4
- Uterine Cervical Neoplasms · Phase 2
- Uterine Diseases · Phase 4
- Vascular Diseases · Phase 4
- Venous Thrombosis · Phase 4
- Vomiting · Phase 3
- Wound Healing · Phase 1
- Wound Infection · Phase 2/Phase 3
- Wounds and Injuries · Phase 4
Mechanism of action
- Unspecified targetOTHER
Unknown
Unknown
TRPA1 agonist
- CyclooxygenaseINHIBITOR
Cyclooxygenase inhibitor
- Vanilloid receptorOPENER
TRPV1 opener
Active metabolite, AM404, activates vanilloid receptor (TRPV1)
- Cannabinoid CB1 receptorAGONIST
CNR1 agonist
- Anandamide amidohydrolaseINHIBITOR
FAAH inhibitor
FAAH converts acetaminophen into the active metabolite AM404, but this conversion also competes with degradation of anandamide increasing its concentration and effects
Combination products
advil dual action with acetaminophen
with ibuprofen
Also known as combogesic
anoquan
with caffeine, butalbital
Also known as esgic-plus
apadaz
with benzhydrocodone
capital and codeine
with codeine
Also known as codrix, papa-deine, phenaphen w/ codeine , tylenol w/ codeine, tylenol w/ codeine
codeine, aspirin, apap formula
with acetylsalicylic acid, codeine
co-gesic
with hydrocodone
Also known as allay, anexsia, bancap hc, hydrocodone/acetaminophen 5 mg-325 mg oral tablet, hy-phen, lorcet-h, lortab, norcet, norco, tycolet, vicodin, vicodin es, vicodin hp, zydone, zyfrel
darvocet
with propoxyphene
Also known as darvocet a, darvocet-n, wygesic
dhc plus
with caffeine, dihydrocodeine
Also known as synalgos-dc-a, trezix
drixoral plus
excedrin (migraine relief)
with caffeine, acetylsalicylic acid
fioricet w/ codeine
with caffeine, codeine, butalbital
Also known as butalbital; acetaminophen; caffeine; codeine, phrenilin with caffeine and codeine
percocet
with oxycodone
Also known as oxycet, oxycodone 2.5/apap, oxycodone 5/apap, oxycodone and acetaminophen, pro-229, roxicet, roxilox, tylox, xartemis xr
phrenilin
with butalbital
Also known as allzital, bucet, butapap, phrenilin forte, sedapap, tencon, triaprin
talacen
with pentazocine
tavist allergy/sinus/headache
with clemastine, pseudoephedrine
ultracet
with tramadol
Approval history
- approvedJun 1, 1950
Chemistry & pharmacology
SMILES
CC(=O)NC1=CC=C(O)C=C1- Mol. weight
- 151.1626 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- Yes
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral, Parenteral, Topical
- Availability
- Over the Counter
Oral
Yes
Parenteral
Yes
Topical
Yes
Sources
- WikipediaAPAP ↗
- NCATS362O9ITL9D ↗
- WikipediaParacetamol ↗
- ChEMBLCHEMBL71595 ↗
- NCATSBBX060AN9V ↗
- WikipediaOxydol ↗
- ChEMBLCHEMBL112 ↗
Also known as
- 4-acetamidophenol
- 4-acetamidophenol
- 4-(acetylamino)phenol
- 4-(acetylamino)phenol
- 4'-hydroxyacetanilide
- 4'-hydroxyacetanilide
- abdine
- acenol
- acenol
- acephen
- acephen
- acetaminofen
- acetaminofén
- acetaminofén
- acetaminophen
- acetaminophen
- acetaminophen
- acetaminophen
- acetaminophen
- acetaminophen
- acetaminophen
- acetaminophen
- acetaminophen
- acetaminophen
- acétaminophène
- acétaminophène
- acetaminophen mixture with caffeine and dipyrone
- acetaminophen mixture with oxycodone hydrochloride
- acetominophen
- acetominophen
- alvedon
- alvedon
- aminofen
- angiers
- apap
- apap
- apap
- apap
- calpol
- calpol
- calpol six plus
- calpol six plus fastmelts
- child lemsip
- crystacide
- crystacide
- cupanol
- dafalgan
- dafalgan
- dafalgan
- datril
- datril
- disprol
- disprol
- disprol infant
- disprol jnr
- disprol paed
- fennings
- galpamol
- hedex
- hedex
- hioxyl
- hioxyl
- hydrogen peroxide
- hydrogen peroxide
- hydrogen peroxide
- hydrogen peroxide
- hydrogen peroxide
- hydrogen peroxide
- hydrogen peroxide
- hydrogen peroxide
- hydrogen peroxide topical solution
- hydroxyphenolacetamide
- hyrdogen peroxide
- iff flavor 316 282
- infadrops
- infadrops
- infants' feverall
- infants' feverall
- injectapap
- injectapap
- junior parapaed
- mandanol
- medinol
- medinol
- medinol for children
- medinol over 6
- medinol under 6
- medised plain
- miradol
- miradol
- mnk-795
- n-acetyl-p-aminophenol
- n-acetyl-p-aminophenol
- neopap
- neopap
- neopap
- ofirmev
- ofirmev
- oxycodone-acetaminophen
- oxydol
- oxydol
- oxydol
- oxydol
- oxydol
- p-acetamidophenol
- p-acetamidophenol
- p-acetaminophenol
- p-acetaminophenol
- p-acetylaminophenol
- p-acetylaminophenol
- paldesic
- paldesic
- panadol
- panadol
- panadol
- panadol
- panadol actifast
- panadol actifast solb
- panadol advan
- panadol jnr
- panadol oa
- panaleve
- panaleve
- panaleve 6 plus
- paracetamol
- paracetamol
- paracetamol
- paracetamol
- paracetamol
- paracetamol
- paracétamol
- paracétamol
- paracetamolum
- paracetamolum
- paramin
- parapaed jnr
- parapaed six plus
- paravict
- paxerol
- percocet
- percocet
- percocet
- perfalgan
- perfalgan
- perfalgan
- peroxide
- peroxide
- peroxyl
- peroxyl
- phenaphen
- phenaphen
- phpa cpd
- p-hydroxy-acetanilid
- p-hydroxy-acetanilid
- p-hydroxyacetanilide
- p-hydroxyacetanilide
- p-hydroxyphenolacetamide
- p-hydroxyphenolacetamide
- p-hydroxyphenolacetamide
- placidex
- placidex
- rimadol
- salzone
- salzone
- sch 484
- tixymol
- tramadol hydrochloride and acetaminophen
- tramil 500
- tylenol
- tylenol
- tylenol
- tylenol
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07225634 | Phase 3 | Feb 28, 2026 | AFT Pharmaceuticals, Ltd. |
| NCT07225140 | Phase 3 | Feb 28, 2026 | AFT Pharmaceuticals, Ltd. |
| NCT07203079 | Phase 4 | Jan 31, 2026 | Stanford University |
| NCT07269756 | Phase 1 | Dec 31, 2025 | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| NCT07235995 | Phase 4 | Dec 1, 2025 | Central South University |
| NCT07200544 | Phase 4 | Nov 30, 2025 | University of Oklahoma |
| NCT07264309 | N/A | Nov 1, 2025 | Emek Medical Center |
| NCT07158476 | Phase 4 | Oct 21, 2025 | St. Louis University |
| NCT06997016 | Phase 4 | Oct 15, 2025 | Baylor University |
| NCT07197684 | N/A | Oct 6, 2025 | Aga Khan University |
| NCT07195669 | Phase 4 | Oct 1, 2025 | Louisiana State University |
| NCT07169227 | Phase 4 | Sep 30, 2025 | Baskent University |
| NCT07024199 | Phase 4 | Sep 30, 2025 | Medical University of Warsaw |
| NCT07101445 | Phase 4 | Sep 24, 2025 | Emory University, Gamida Cell, National Cancer Institute (NCI) |
| NCT07017452 | Phase 3 | Aug 31, 2025 | University of Manitoba |
| NCT07102641 | Phase 4 | Aug 26, 2025 | Thomas Jefferson University |
| NCT06994442 | Phase 3 | Aug 20, 2025 | Cornell University, National Institutes of Health (NIH) |
| NCT07104097 | N/A | Aug 11, 2025 | University of Brescia |
| NCT06950840 | Phase 4 | Aug 1, 2025 | Tel Aviv University |
| NCT07040709 | N/A | Jun 8, 2025 | Gaziosmanpasa University |
Organizations
Research & Development (788)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Johnson and Johnson | For profit | 44 | 44 | 5 | 1999 |
| GlaxoSmithKline | For profit | 35 | 34 | 5 | 2004 |
| Mallinckrodt | For profit | 35 | 19 | 5 | 2006 |
| McNeil | For profit | 25 | 5 | 5 | 1999 |
| Yeshiva University | Academic/Hospital | 19 | 17 | 4 | 2010 |
| Cairo University | Academic/Hospital | 18 | 17 | 5 | 2016 |
| Harvard University | Academic/Hospital | 17 | 15 | 5 | 2010 |
| Merck | For profit | 16 | 15 | 3 | 1998 |
| Pamukkale University | Academic/Hospital | 15 | 13 | 2 | 2011 |
| Thomas Jefferson University | Academic/Hospital | 14 | 12 | 3 | 2008 |
| University Clermont Auvergne | Academic/Hospital | 14 | 14 | 4 | 2007 |
| University of Copenhagen | Academic/Hospital | 14 | 12 | 4 | 2006 |
| Janssen Pharmaceutica NV | For profit | 13 | 2 | 3 | 2005 |
| Pfizer | For profit | 13 | 10 | 5 | 2004 |
| Sanofi | For profit | 12 | 7 | 4 | 2006 |
| University of Western Ontario | Academic/Hospital | 11 | 9 | 4 | 2008 |
| Ain Shams University | Academic/Hospital | 10 | 10 | 4 | 2011 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 10 | 9 | 4 | 1999 |
| Stanford University | Academic/Hospital | 10 | 10 | 4 | 1996 |
| University of California, San Francisco | Academic/Hospital | 10 | 5 | 5 | 1996 |
Marketing (214)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| AACE PHARMS | For profit | MKTG | Aug 16, 2022 |
| AAIPharma | For profit | MKTG | Oct 18, 1972 |
| AAIPharma | For profit | NDA2 | Oct 18, 1972 |
| ACI Limited | For profit | MKTG | Mar 27, 1979 |
| ACI Limited | For profit | MKTG | Mar 27, 1979 |
| ACP Nimble | For profit | NDA2 | Feb 9, 1978 |
| AFT PHARMS LTD | For profit | NDA2 | Mar 1, 2023 |
| AH Robins | For profit | MKTG | Jul 22, 1975 |
| ANDA Repository | For profit | MKTG | Oct 27, 1992 |
| Abana | For profit | MKTG | May 15, 1986 |
| AbbVie | For profit | MKTG | Jan 7, 1983 |
| Abbott | For profit | MKTG | May 25, 1984 |
| Abhai LLC | For profit | MKTG | Jun 21, 2017 |
| Able Laboratories | For profit | MKTG | Jul 11, 2001 |
| Acino | For profit | MKTG | May 12, 1987 |
| Aclaris Therapeutics, Inc. | For profit | NDA2 | Dec 14, 2017 |
| Actavis | For profit | MKTG | Jan 2, 1987 |
| Actavis | For profit | SYN | Jun 2, 2016 |
| Actavis | For profit | SYN | Nov 9, 1984 |
| Actavis | For profit | SYN | Jun 20, 1978 |
| Actavis | For profit | NDA2 | Jul 30, 1992 |
| Akorn, Inc. | For profit | MKTG | Apr 26, 1996 |
| Alkem Labs Ltd | For profit | MKTG | Mar 30, 2012 |
| Allergan | For profit | MKTG | Feb 14, 1997 |
| Allergan PLC (2015) | For profit | MKTG | Jun 2, 2016 |
| Alvogen | For profit | SYN | Jul 26, 2012 |
| Alvogen | For profit | SYN | Oct 24, 2018 |
| Alvogen | For profit | MKTG | Jul 26, 2012 |
| Am Therap | For profit | MKTG | Mar 3, 1987 |
| American Cyanamid | For profit | MKTG | Nov 3, 1982 |
| Amneal Pharmaceuticals | For profit | MKTG | Nov 27, 2007 |
| Amneal Pharmaceuticals | For profit | SYN | Aug 25, 2006 |
| Apax Partners | For profit | MKTG | Jan 24, 2011 |
| Apotex | For profit | MKTG | Apr 7, 2014 |
| Apotex | For profit | SYN | Apr 7, 2014 |
| Ascent Pharmahealth | For profit | MKTG | Mar 22, 2017 |
| Ascher | For profit | MKTG | May 3, 1982 |
| Aspiro | For profit | MKTG | Jul 27, 2022 |
| Aurobindo Pharma | For profit | MKTG | Nov 9, 2016 |
| Aurobindo Pharma | For profit | SYN | Apr 11, 2012 |
| Aurobindo Pharma | For profit | SYN | Nov 9, 2016 |
| Avon Products | For profit | MKTG | Jul 8, 1982 |
| B. Braun | For profit | MKTG | Feb 18, 2021 |
| B. Braun | For profit | NDA2 | Feb 18, 2021 |
| Barr Laboratories | For profit | MKTG | Nov 2, 1981 |
| Bausch Health Companies | For profit | MKTG | Jun 19, 1985 |
| Bausch Health Companies | For profit | SYN | Apr 26, 1978 |
| Bausch Health Companies | For profit | SYN | Jan 8, 1979 |
| Baxalta | For profit | MKTG | Sep 17, 2021 |
| Bionpharma Inc | For profit | MKTG | Aug 1, 2023 |
| Boca Pharmacal | For profit | MKTG | Apr 3, 2007 |
| Boehringer Ingelheim | For profit | MKTG | Jan 12, 1989 |
| Bristol-Myers Squibb | For profit | MKTG | Oct 25, 1977 |
| Caraco Pharmaceutical Laboratories | For profit | MKTG | Sep 3, 1976 |
| Carnrick Laboratories | For profit | MKTG | May 31, 1974 |
| Century Pharmaceuticals | For profit | MKTG | Mar 27, 1985 |
| Cerovene | For profit | MKTG | Dec 13, 2016 |
| Chartwell Pharmaceuticals | For profit | SYN | Nov 10, 2011 |
| Chartwell Pharmaceuticals | For profit | MKTG | Aug 15, 2019 |
| Cosette | For profit | MKTG | Feb 9, 1978 |
| Cosette | For profit | NDA2 | Feb 9, 1978 |
| County Line | For profit | MKTG | Oct 30, 2015 |
| Custopharm Inc | For profit | MKTG | Jun 13, 2016 |
| Cypress Pharmaceutical | For profit | MKTG | Apr 14, 2016 |
| DAVA Pharmaceuticals | For profit | MKTG | Sep 20, 1996 |
| Dr. Reddy's Laboratories | For profit | MKTG | Mar 17, 1986 |
| Dunhall Pharmaceuticals | For profit | MKTG | Jul 2, 1987 |
| Duramed Research | For profit | MKTG | Feb 6, 1984 |
| Elite Laboratories, Inc | For profit | MKTG | Jul 2, 2018 |
| Emcure | For profit | MKTG | May 31, 2018 |
| Epic Pharma Llc | For profit | MKTG | Mar 30, 2018 |
| Eugia Pharma | For profit | MKTG | Oct 21, 2020 |
| Everylife Foundation for Rare Diseases | Academic/Hospital | MKTG | Mar 17, 1978 |
| Exeltis | For profit | SYN | Dec 13, 2016 |
| Exeltis | For profit | MKTG | Dec 13, 2016 |
| Eywa Pharma | For profit | MKTG | Jun 27, 2019 |
| Forest Laboratories | For profit | MKTG | Mar 17, 1983 |
| Fosun | For profit | MKTG | Jul 16, 1992 |
| Fresenius | For profit | NDA2 | Oct 28, 2015 |
| G & W Laboratories Inc. | For profit | MKTG | Mar 27, 1992 |
| Gavis Pharmaceuticals | For profit | MKTG | Aug 2, 2002 |
| Genus Oncology, LLC | For profit | MKTG | Jul 19, 2011 |
| Genus Oncology, LLC | For profit | SYN | Jul 19, 2011 |
| GlaxoSmithKline | For profit | MKTG | Jan 14, 1998 |
| GlaxoSmithKline | For profit | NDA2 | Feb 28, 2020 |
| Graham Dm | For profit | MKTG | Mar 27, 1985 |
| Granules India | For profit | MKTG | Apr 16, 2019 |
| Granules India | For profit | SYN | Oct 31, 2019 |
| Granules India | For profit | SYN | Apr 16, 2019 |
| Graviti Pharmaceuticals | For profit | MKTG | Jul 26, 2006 |
| Halsey | For profit | MKTG | May 13, 1988 |
| Heritage Pharma | For profit | MKTG | May 31, 2018 |
| Hi Tech Pharmaceuticals | For profit | MKTG | Apr 26, 1996 |
| Hikma | For profit | MKTG | Mar 23, 2001 |
| Hikma | For profit | SYN | Jun 12, 1995 |
| Hikma | For profit | SYN | Feb 25, 1980 |
| Hikma | For profit | NDA2 | Jun 3, 2022 |
| Hq Speciality Pharma | For profit | MKTG | May 3, 2023 |
| International Minerals and Chemical Corporation | For profit | NDA2 | Nov 2, 2010 |
| International Minerals and Chemical Corporation | For profit | MKTG | Apr 23, 1987 |
| Ivax | For profit | MKTG | Apr 21, 1988 |
| Johnson and Johnson | For profit | SYN | May 26, 1976 |
| Johnson and Johnson | For profit | MKTG | Jul 9, 1976 |
| Johnson and Johnson | For profit | SYN | Aug 17, 1977 |
| Johnson and Johnson | For profit | NDA2 | May 26, 1976 |
| Kvk Tech Inc | For profit | MKTG | Feb 23, 2018 |
| LGM Pharma | For profit | MKTG | Jun 10, 2004 |
| Laboratoires Gilbert | For profit | MKTG | — |
| Lannett Company, Inc. | For profit | MKTG | Nov 10, 2011 |
| Larken Labs Inc | For profit | MKTG | Dec 4, 2015 |
| Lederle | For profit | MKTG | Nov 3, 1982 |
| Leitner Pharms | For profit | MKTG | May 14, 1986 |
| Lumara Health | For profit | MKTG | Aug 23, 1977 |
| Macleods Pharmaceuticals, Ltd | For profit | MKTG | May 2, 2017 |
| Mallinckrodt | For profit | SYN | Nov 2, 2010 |
| Mallinckrodt | For profit | SYN | Jul 8, 1982 |
| Mallinckrodt | For profit | MKTG | Aug 29, 2003 |
| Marksans Pharma | For profit | MKTG | Aug 25, 2021 |
| Mayne Pharma | For profit | MKTG | Mar 17, 1986 |
| Mayrand | For profit | MKTG | Oct 17, 1985 |
| McNeil | For profit | NDA | — |
| Micro Labs Ltd India | For profit | MKTG | Dec 14, 2012 |
| Mikart | For profit | MKTG | Feb 21, 1986 |
| Mikart | For profit | SYN | Nov 27, 2018 |
| Mirror Pharms | For profit | MKTG | Feb 11, 2008 |
| Mirror Pharms | For profit | SYN | Dec 23, 2008 |
| Mutual Pharmaceutical | For profit | MKTG | Jan 20, 1978 |
| Mylan | For profit | MKTG | Oct 25, 1974 |
| Mylan | For profit | SYN | Dec 30, 1985 |
| Mylan | For profit | SYN | Jan 15, 2021 |
| Nautic Partners | For profit | MKTG | Nov 27, 2018 |
| Neogen | For profit | MKTG | May 2, 2017 |
| Nesher Pharms | For profit | MKTG | Jan 23, 2002 |
| Nexgen Pharma, Inc | For profit | MKTG | Nov 16, 2009 |
| Nexgen Pharma, Inc | For profit | SYN | Jun 10, 2004 |
| Nostrum Laboratories | For profit | MKTG | Jul 2, 2018 |
| Novartis | For profit | MKTG | Mar 1, 2001 |
| Novartis | For profit | NDA2 | Mar 1, 2001 |
| Novast Labs | For profit | MKTG | Dec 1, 2008 |
| Novel Anti-Infective Technologies, LLC | For profit | MKTG | Nov 14, 2016 |
| Nuvo Research Inc. | For profit | MKTG | Oct 28, 2016 |
| Ohm Laboratories, Inc. | For profit | MKTG | Mar 19, 2002 |
| Par Pharmaceuticals | For profit | MKTG | Apr 21, 2005 |
| Pernix | For profit | MKTG | Apr 14, 2016 |
| Perrigo | For profit | MKTG | Feb 25, 2000 |
| Perrigo | For profit | SYN | Dec 1, 1986 |
| Perrigo | For profit | SYN | Feb 28, 2023 |
| Pfizer | For profit | NDA2 | Feb 28, 2020 |
| Pharmaceutical Associates | For profit | MKTG | Aug 21, 1981 |
| Pharmaceutical Research Associates, Inc. (PRA) | For profit | MKTG | Mar 4, 1986 |
| Polymedica | For profit | NDA2 | Nov 7, 1968 |
| Prinston Inc | For profit | MKTG | Dec 30, 2021 |
| Puracap Pharmaceutical | For profit | MKTG | Dec 10, 1982 |
| Puracap Pharmaceutical | For profit | SYN | May 11, 1979 |
| R.P. Scherer | For profit | MKTG | May 10, 1978 |
| Rafael Pharmaceuticals Inc. | For profit | MKTG | May 7, 2004 |
| Ranbaxy | For profit | MKTG | Aug 16, 2007 |
| Ranbaxy | For profit | SYN | Aug 16, 2007 |
| Rhodes Pharmaceuticals, L.P. | For profit | MKTG | Feb 10, 1988 |
| RiconPharma | For profit | MKTG | Nov 17, 2021 |
| Rising Pharmaceuticals | For profit | SYN | Sep 26, 2008 |
| Rising Pharmaceuticals | For profit | MKTG | Jul 26, 2006 |
| Rising Pharmaceuticals | For profit | NDA2 | Jan 15, 2021 |
| Roxane Laboratories | For profit | MKTG | May 10, 1976 |
| Sandoz | For profit | MKTG | Feb 10, 1977 |
| Sandoz | For profit | SYN | Mar 22, 2016 |
| Sanofi-Aventis | For profit | MKTG | Sep 23, 1982 |
| Sanofi-Aventis | For profit | NDA2 | Sep 23, 1982 |
| Schering-Plough | For profit | MKTG | May 22, 1987 |
| Schering-Plough | For profit | NDA2 | May 22, 1987 |
| Senores Pharms | For profit | MKTG | Aug 13, 2021 |
| Shijiazhuang Pharma Group (CSPC) | For profit | MKTG | Jul 26, 2006 |
| Shire | For profit | MKTG | Oct 1, 1986 |
| SmithKline Beecham | For profit | MKTG | Feb 14, 1997 |
| Solvay | For profit | MKTG | — |
| Specgx Llc | For profit | MKTG | Dec 7, 1983 |
| Strides Pharma Science | For profit | MKTG | Jul 8, 2020 |
| Sun Pharmaceuticals | For profit | SYN | Dec 16, 2005 |
| Sun Pharmaceuticals | For profit | MKTG | Nov 6, 1978 |
| Sun Pharmaceuticals | For profit | SYN | Jul 29, 2005 |
| Superpharm | For profit | MKTG | Oct 18, 1985 |
| Takeda | For profit | MKTG | Sep 17, 2021 |
| Taro Pharmaceuticals | For profit | NDA2 | Apr 22, 1980 |
| Taro Pharmaceuticals | For profit | MKTG | Apr 22, 1980 |
| Teva | For profit | SYN | Aug 2, 1985 |
| Teva | For profit | SYN | Dec 29, 1983 |
| Teva | For profit | MKTG | Dec 29, 1983 |
| Tris Pharma, Inc. | For profit | MKTG | Mar 27, 2013 |
| UCB | For profit | MKTG | May 3, 1982 |
| US CHEM | For profit | MKTG | — |
| Upsher-Smith Laboratories | For profit | MKTG | Mar 24, 2017 |
| Upsher-Smith Laboratories | For profit | SYN | Jun 22, 1982 |
| Vanguard | For profit | MKTG | Mar 20, 1984 |
| Vintage | For profit | MKTG | Sep 30, 1988 |
| Vintage | For profit | SYN | Sep 7, 1988 |
| Vintage | For profit | SYN | Aug 31, 1976 |
| VistaPharm, Inc. | For profit | MKTG | Jan 25, 2012 |
| Vitarine | For profit | MKTG | — |
| Warner Chilcott | For profit | MKTG | Mar 14, 1978 |
| Watson Pharmaceuticals | For profit | MKTG | May 26, 1982 |
| Watson Pharmaceuticals | For profit | SYN | Jan 22, 2003 |
| Wes Pharma Inc | For profit | MKTG | Oct 30, 2017 |
| West-Ward Pharmaceutical | For profit | SYN | Sep 22, 2006 |
| West-Ward Pharmaceutical | For profit | MKTG | Feb 25, 1980 |
| Whiteworth Towne Paulsen | For profit | MKTG | Dec 19, 1977 |
| Wockhardt | For profit | SYN | Jul 22, 1981 |
| Wockhardt | For profit | MKTG | Mar 16, 2007 |
| Wraser Pharmaceuticals | For profit | MKTG | Apr 3, 2007 |
| Xanodyne Pharmaceuticals | For profit | MKTG | Dec 19, 1972 |
| Xanodyne Pharmaceuticals | For profit | NDA2 | Dec 19, 1972 |
| Xspire Pharma | For profit | MKTG | Aug 4, 2017 |
| Zevra Therapeutics | For profit | NDA2 | Feb 23, 2018 |
| Zydus Discovery DMCC | For profit | MKTG | Sep 6, 2012 |
| Zydus Discovery DMCC | For profit | SYN | Oct 25, 2022 |