atorvastatin
Trade name: lipitor
Small moleculeapproved
Approved
Dec 17, 1996
Atorvastatin calcium (LIPITOR®) is a pyrrole and heptanoic acid derivative, a synthetic lipid-lowering agent. Atorvastatin is a selective, competitive inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin is used to reduce serum levels of LDL(low-density lipoprotein)-cholesterol; apolipoprotein B; and triglycerides and to increase serum levels of HDL(high-density lipoprotein)-cholesterol in the treatment of hyperlipidemias and prevention of cardiovascular disease in patients with multiple risk factors. — NCATS
Clinical trial activity
933 trials · 647 clinical orgs · 33 marketing orgs
Phase 1
161
Phase 2
376
Phase 3
237
Phase 4
275
Earliest trial started Jan 1, 1997 (NCT00327418)
Timeline
1990s
- Dec 17, 1996
Pharmacia & Upjohn — Earliest FDA Approval
- Dec 17, 1996
Pfizer — NDA Secondary Org
- Dec 17, 1996
Upjohn — Marketing Organization
- Dec 17, 1996
Pharmacia & Upjohn — NDA Secondary Org
- Dec 17, 1996
Pharmacia & Upjohn — NDA Organization
- Jan 1, 1998
Earliest Phase 3 Sponsor(trial)
- Jan 1, 1999
Earliest Phase 1 Sponsor(trial)
2010s
- Nov 30, 2011
Sun Pharmaceuticals — Marketing Organization
- May 29, 2012
Apotex — Marketing Organization
- May 29, 2012
Mylan — Marketing Organization
- May 29, 2012
Sandoz — Marketing Organization
- May 29, 2012
Teva — Marketing Organization
- May 29, 2012
Novartis — Marketing Organization
- Jul 17, 2012
Dr. Reddy's Laboratories — Marketing Organization
- Apr 5, 2013
Lannett Company, Inc. — Marketing Organization
- May 3, 2013
Merck — Marketing Organization
- May 3, 2013
Organon — NDA Secondary Org
- May 3, 2013
Merck — NDA Secondary Org
- May 19, 2016
Sciegen Pharmaceticals — Marketing Organization
- Jan 9, 2017
Invagen Pharms — Marketing Organization
- Jan 9, 2017
Cipla — Marketing Organization
- Mar 30, 2018
Accord Research — Marketing Organization
- Jun 18, 2018
Graviti Pharmaceuticals — Marketing Organization
- Nov 20, 2018
Zydus Discovery DMCC — Marketing Organization
- Dec 21, 2018
Alkem Labs Ltd — Marketing Organization
- Dec 21, 2018
Thepharmanetwork Llc — Marketing Organization
- Feb 8, 2019
MSN Laboratories — Marketing Organization
- Mar 6, 2019
Lupin — Marketing Organization
- Nov 7, 2019
Micro Labs Ltd India — Marketing Organization
2020s
- Jun 23, 2020
Perrigo — Marketing Organization
- Aug 19, 2020
Umedica Labs Pvt Ltd — Marketing Organization
- Sep 2, 2021
August Bioservices — Marketing Organization
- Sep 2, 2021
Agnitio — Marketing Organization
- Nov 3, 2022
Lepu Medical Technology (Beijing) Co., Ltd. — Marketing Organization
- Nov 23, 2022
Biocon Limited — Marketing Organization
- Feb 1, 2023
CMP Therapeutics Ltd — Marketing Organization
- Feb 1, 2023
CMP Therapeutics Ltd — NDA Secondary Org
- Sep 12, 2023
Hetero Labs Ltd — Marketing Organization
Indications
Approved for
Studied for
- Abortion, Induced · Early Phase 1
- Acne Vulgaris · Phase 4
- Acute Chest Syndrome · Phase 3
- Acute Coronary Syndrome · Phase 4
- Acute Kidney Injury · Phase 4
- Adrenal Insufficiency · Phase 4
- Aged · Phase 4
- Aging · Phase 4
- AIDS Dementia Complex · Phase 4
- Alagille Syndrome · Phase 4
- Alzheimer Disease · Phase 4
- Anemia, Sickle Cell · Phase 2
- Anesthesia, Spinal · Phase 4
- Angina Pectoris · Phase 4
- Angina Pectoris, Variant · Phase 4
- Angina, Unstable · Phase 4
- Angioplasty · Phase 4
- Angioplasty, Balloon, Coronary · Phase 2
- Anterior Wall Myocardial Infarction · Phase 4
- Antimetabolites · Phase 4
- Aortic Aneurysm, Abdominal · Phase 4
- Aortic Coarctation · Phase 4
- Aortic Diseases · Phase 3
- Aortic Valve Stenosis · Phase 4
- Arrhythmias, Cardiac · Phase 4
- Arterial Occlusive Diseases · Phase 2/Phase 3
- Arteriosclerosis · Phase 4
- Arthritis, Rheumatoid · Phase 4
- Ascites · Phase 2/Phase 3
- Asthma · Phase 2/Phase 3
- Atherosclerosis · Phase 4
- Atorvastatin · Phase 4
- Atrial Fibrillation · Phase 4
- Bicuspid Aortic Valve Disease · Phase 3
- Bile Acids and Salts · Phase 4
- Blood Circulation · Phase 1
- Blood Platelet Disorders · Phase 2
- Blood Pressure · Phase 4
- Body Weight · Phase 1
- Bone Marrow Cells · Phase 2
- Brain Death · Phase 4
- Brain Injuries, Traumatic · Phase 2
- Breast Neoplasms · Phase 4
- Bronchiectasis · Phase 4
- Calcinosis · Phase 4
- Carcinoma, Hepatocellular · Phase 4
- Carcinoma, Renal Cell · Phase 3
- Cardiomyopathies · Phase 4
- Cardiomyopathy, Hypertrophic · Phase 3
- Cardiotoxicity · Phase 2
- Cardiovascular Diseases · Phase 4
- Carotid Artery Diseases · Phase 4
- Carotid Stenosis · Phase 4
- Cerebral Hemorrhage · Phase 2/Phase 3
- Cerebral Infarction · Phase 4
- Cesarean Section · Phase 4
- Chagas Disease · Phase 2
- Cholesterol · Phase 4
- Cholesterol, HDL · Phase 4
- Cholesterol, LDL · Phase 4
- Chromosome Aberrations · Phase 2
- Chronic Kidney Disease-Mineral and Bone Disorder · Phase 4
- Chronic Periodontitis · Phase 2/Phase 3
- Clonal Hematopoiesis · Phase 2
- Cognition · Phase 4
- Cognition Disorders · Phase 3
- Cognitive Dysfunction · Phase 4
- Colitis, Ulcerative · Phase 2
- Colonic Neoplasms · Phase 2
- Colorectal Neoplasms · Phase 2
- Colorectal Neoplasms, Hereditary Nonpolyposis · Early Phase 1
- Constriction, Pathologic · Phase 3
- Coronary Aneurysm · Phase 2
- Coronary Artery Bypass · Phase 4
- Coronary Disease · Phase 4
- Coronary Restenosis · Phase 4
- COVID-19 · Phase 3
- Crohn Disease · Phase 2
- Dementia · Phase 4
- Dementia, Vascular · Phase 4
- Depressive Disorder · Phase 2
- Diabetes Insipidus · Phase 2
- Diabetes Mellitus · Phase 4
- Diabetes Mellitus, Type 1 · Phase 4
- Diabetes Mellitus, Type 2 · Phase 4
- Diarrhea · Phase 4
- Disability Evaluation · Phase 4
- Drug Interactions · Phase 1
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Dry Eye Syndromes · Phase 3
- Dual Anti-Platelet Therapy · Phase 2
- Dyslipidemias · Phase 4
- Elective Surgical Procedures · Phase 4
- Endometrial Hyperplasia · Phase 2
- Endometrial Neoplasms · Phase 2
- Endometriosis · Phase 4
- Endothelial Cells · Phase 4
- Endothelium · Phase 4
- Epilepsy · Phase 1/Phase 2
- Erectile Dysfunction · Phase 2
- Essential Hypertension · Phase 4
- Eunuchism · Phase 4
- Fatty Liver · Phase 4
- Fibrosis · Phase 2/Phase 3
- Fistula · Phase 1/Phase 2
- Foot Ulcer · Phase 2
- Gene Expression · Phase 4
- General Surgery · Phase 4
- Glioblastoma · Phase 2
- Glomerulonephritis, IGA · Phase 2
- Glomerulosclerosis, Focal Segmental · Phase 2
- Glucose Metabolism Disorders · Phase 4
- Graft vs Host Disease · Phase 2
- Graves Ophthalmopathy · Phase 4
- Head and Neck Neoplasms · Phase 3
- Healthy Volunteers · Phase 4
- Hearing Loss · Phase 3
- Heart · Phase 4
- Heart Disease Risk Factors · Phase 3
- Heart Diseases · Phase 4
- Heart Failure, Diastolic · Phase 1
- Heart Failure, Systolic · Phase 4
- Heart Valve Diseases · Phase 3
- Helicobacter pylori · Phase 4
- Hemangioma, Cavernous, Central Nervous System · Phase 1/Phase 2
- Hematoma, Subdural, Chronic · Phase 3
- Hemorrhage · Phase 4
- Hemorrhagic Fever, Ebola · Phase 1/Phase 2
- Hemorrhagic Stroke · Phase 4
- Hemostasis · Phase 4
- Hepatic Encephalopathy · Phase 2/Phase 3
- Hepatitis B · Phase 4
- Hepatitis C · Phase 4
- Hip Fractures · Phase 2
- HIV · Phase 3
- HIV Infections · Phase 4
- HIV Seronegativity · Phase 1
- Hodgkin Disease · Phase 2
- Homozygous Familial Hypercholesterolemia · Phase 3
- Hydroxymethylglutaryl-CoA Reductase Inhibitors · Phase 4
- Hyperglycemia · Phase 4
- Hyperlipidemia, Familial Combined · Phase 3
- Hyperlipoproteinemia Type III · Phase 3
- Hyperlipoproteinemia Type IV · Phase 3
- Hyperparathyroidism, Secondary · Phase 4
- Hyperplasia · Phase 1
- Hypertension, Portal · Phase 2
- Hypertension, Pulmonary · Phase 2
- Hypertension, Renovascular · Phase 3
- Hypertriglyceridemia · Phase 4
- Hypertrophy, Left Ventricular · Phase 3
- Hypotension · Phase 4
- Hypovolemia · Phase 4
- Immune Reconstitution Inflammatory Syndrome · Phase 2/Phase 3
- Immunosuppression Therapy · Phase 4
- Independent Living · Phase 4
- Infertility, Male · Phase 1
- Inflammation · Phase 4
- Inflammatory Bowel Diseases · Phase 2
- Inflammatory Breast Neoplasms · Phase 2
- Influenza, Human · Phase 2
- Insulin Resistance · Phase 4
- Intermittent Claudication · Phase 2/Phase 3
- Intracranial Aneurysm · Phase 2
- Intracranial Arteriosclerosis · Phase 4
- Ischemia · Phase 4
- Ischemic Attack, Transient · Phase 4
- Ischemic Stroke · Phase 4
- Kidney Diseases · Phase 4
- Kidney Failure, Chronic · Phase 1
- Kidney Neoplasms · Phase 3
- Leukemia · Phase 2
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 2
- Leukemia, Myeloid, Acute · Phase 3
- Leukemia, Prolymphocytic · Phase 2
- Lipid Metabolism Disorders · Phase 4
- Lipodystrophy · Phase 1
- Liver Cirrhosis · Phase 4
- Liver Cirrhosis, Biliary · Phase 3
- Liver Diseases · Phase 2
- Lung · Phase 4
- Lupus Erythematosus, Systemic · Phase 4
- Lymphoma · Phase 2
- Lymphoma, Large B-Cell, Diffuse · Phase 2
- Lymphoma, Mantle-Cell · Phase 2
- Lymphoma, Non-Hodgkin · Phase 2
- Macular Degeneration · Phase 2
- Magnetic Resonance Imaging · Phase 4
- Medicine, Chinese Traditional · Phase 4
- Melanoma · Phase 4
- Metabolic Side Effects of Drugs and Substances · Phase 4
- Metabolic Syndrome · Phase 4
- Metabolism · Phase 4
- Migraine Disorders · Phase 2
- Mitochondrial Diseases · Phase 4
- Mood Disorders · Phase 4
- Mucocutaneous Lymph Node Syndrome · Phase 2
- Multiple Myeloma · Phase 2
- Multiple Sclerosis · Phase 2
- Multiple Sclerosis, Relapsing-Remitting · Phase 2
- Muscular Diseases · Phase 4
- Myalgia · Phase 2
- Myelodysplastic Syndromes · Phase 3
- Myeloproliferative Disorders · Phase 2
- Myocardial Ischemia · Phase 4
- Myocardial Stunning · Phase 4
- Myocardium · Phase 3
- Nasopharyngeal Carcinoma · Phase 2
- Neoplasm Metastasis · Phase 3
- Neoplasms · Phase 2/Phase 3
- Neurodegenerative Diseases · Phase 4
- Neuropsychology · Phase 4
- Non-alcoholic Fatty Liver Disease · Phase 4
- Non-ST Elevated Myocardial Infarction · Phase 3
- Obesity · Phase 4
- Osteoarthritis · Phase 4
- Osteoporosis · Phase 4
- Ovarian Neoplasms · Phase 3
- Overweight · Phase 1
- Oxidative Stress · Phase 4
- Percutaneous Coronary Intervention · Phase 4
- Periodontal Diseases · Phase 4
- Periodontitis · Phase 2
- Peripheral Arterial Disease · Phase 4
- Peripheral Vascular Diseases · Phase 4
- Peritonitis · Phase 2/Phase 3
- Pharmacokinetics · Phase 4
- Pharmacology · Phase 4
- Plaque, Atherosclerotic · Phase 4
- Pneumonia, Ventilator-Associated · Early Phase 1
- Polycystic Kidney, Autosomal Dominant · Phase 2
- Polycystic Ovary Syndrome · Phase 2
- Postmenopause · Phase 2
- Postoperative Complications · Phase 4
- Precancerous Conditions · Phase 2
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma · Phase 2
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 3
- Prediabetic State · Phase 4
- Pre-Eclampsia · Phase 3
- Prostatic Hyperplasia · Phase 4
- Prostatic Neoplasms · Phase 3
- Psoriasis · Phase 3
- Pulmonary Disease, Chronic Obstructive · Phase 4
- Purpura, Thrombocytopenic · Phase 4
- Purpura, Thrombocytopenic, Idiopathic · Phase 4
- Quality of Life · Phase 4
- Radiation Oncology · Phase 2
- Rectal Neoplasms · Phase 2
- Renal Artery Obstruction · Phase 3
- Renal Insufficiency · Phase 3
- Renal Insufficiency, Chronic · Phase 4
- Reperfusion Injury · Phase 4
- Retinal Drusen · Phase 4
- Retinal Vein Occlusion · Phase 3
- Retroperitoneal Fibrosis · Phase 4
- Sarcoidosis, Pulmonary · Phase 2
- SARS-CoV-2 · Phase 2/Phase 3
- Schizophrenia · Phase 3
- Scleroderma, Systemic · Phase 2
- Sepsis · Phase 2
- Sleep Apnea, Obstructive · Phase 2
- Sleep Wake Disorders · Phase 1
- Smoking · Phase 4
- Spastic Paraplegia, Hereditary · Phase 2
- Sprains and Strains · Phase 4
- ST Elevation Myocardial Infarction · Phase 4
- Stem Cell Transplantation · Phase 2
- Stents · Phase 4
- Stress Disorders, Post-Traumatic · Phase 2
- Subarachnoid Hemorrhage · Phase 3
- Therapeutic Equivalency · Phase 1
- Thoracic Surgery · Phase 4
- Thrombocytopenia · Early Phase 1
- Thrombosis · Phase 4
- Triple Negative Breast Neoplasms · Phase 2
- Tuberculosis · Phase 2/Phase 3
- Tuberculosis, Pulmonary · Phase 2/Phase 3
- Ultrasonography, Interventional · Phase 4
- Vaccination · Phase 4
- Vaccines · Phase 4
- Varicose Veins · Phase 2/Phase 3
- Vascular Calcification · Phase 3
- Vascular Diseases · Phase 4
- Vascular Grafting · Phase 3
- Vascular Stiffness · Phase 4
- Vascular Surgical Procedures · Phase 4
- Venous Thromboembolism · Phase 2
- Vitamin D Deficiency · Phase 4
- Vitiligo · Phase 2
- Waldenstrom Macroglobulinemia · Phase 2
- White Matter · Phase 4
- Xanthomatosis · Phase 4
Mechanism of action
- HMG-CoA reductaseINHIBITOR
HMGCR inhibitor
Combination products
caduet
with amlodipine
liptruzet
with ezetimibe
Approval history
- approvedPriority reviewDec 17, 1996
Chemistry & pharmacology
Loading structure…
SMILES
CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O- Mol. weight
- 558.65 g/mol
- Lipinski Ro5
- 2 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL1487 ↗
- WikipediaAtorvastatin ↗
- NCATSA0JWA85V8F ↗
- ChEMBLCHEMBL393220 ↗
- ChEMBLCHEMBL1790017 ↗
Also known as
- ag1502
- amlodipine/atorvastatin
- artovastatin
- atorvastatin
- atorvastatin
- atorvastatin
- atorvastatin
- atorvastatin
- atorvastatin
- atorvastatin
- atorvastatin
- atorvastatin acid
- atorvastatin calcium
- atorvastatin calcium
- atorvastatin calcium
- atorvastatin calcium
- atorvastatin calcium
- atorvastatin calcium anhydrous
- atorvastatin calcium hydrate
- atorvastatin calcium trihydrate
- atorvastatin calcium trihydrate
- atorvastatin sodium
- atorvastin
- atrovastatin
- cardyl
- cardyl
- cardyl
- ci981
- ci-981
- ci-981
- ci-981
- ci-981
- ci-981
- ci-981
- cj-30056
- cj-30056
- ezetimibe / atorvastatin
- hl040xc
- hl-040xc
- lipitor
- lipitor
- lipitor
- lipitor
- lipovastatinklonal
- lipovastatinklonal
- prevencor
- prevencor
- sortis
- sortis
- tahor
- tahor
- tulip
- tulip
- zarator
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07268625 | Phase 1 | Jan 5, 2026 | Daiichi Sankyo |
| NCT07303699 | Phase 2 | Jan 3, 2026 | Obafemi Awolowo University, Open Philanthropy Project |
| NCT07265466 | Phase 1 | Nov 17, 2025 | Onconic Therapeutics Inc. |
| NCT07180745 | Phase 4 | Nov 1, 2025 | Badr University |
| NCT07235189 | Phase 1 | Oct 28, 2025 | Daiichi Sankyo |
| NCT07042165 | Phase 4 | Oct 15, 2025 | Aase and Ejnar Danielsens Foundation, University of Copenhagen |
| NCT07197463 | N/A | Oct 10, 2025 | Shandong University |
| NCT06961630 | Early Phase 1 (Phase 1) | Oct 7, 2025 | National Heart, Lung, and Blood Institute (NHLBI), New York University |
| NCT07012629 | Phase 3 | Sep 1, 2025 | Aalborg University, Aarhus University, Gødstrup Hospital, Lund University, University of Bern, University of Copenhagen, University of Hamburg, University of Oslo, University of Southern Denmark |
| NCT06974084 | Phase 2/Phase 3 (Phase 3) | Sep 1, 2025 | HealthBio, Inc. |
| NCT07096765 | N/A | Aug 1, 2025 | Uludag University |
| NCT07036991 | Phase 4 | Jul 30, 2025 | Changhai Hospital, Soochow University |
| NCT07045142 | Phase 3 | Jul 1, 2025 | Central South University, The Second People's Hospital of Dali Bai Autonomous Prefecture |
| NCT06930885 | Phase 3 | Jun 12, 2025 | Hcor Research Institute, Hospital do Coracao |
| NCT06978491 | N/A | May 16, 2025 | Eskisehir Osmangazi University |
| NCT06948747 | Phase 1 | May 6, 2025 | AstraZeneca |
| NCT06841536 | N/A | May 1, 2025 | National Hospital of the Faroe Islands, University of Copenhagen, University of the Faroe Islands |
| NCT06922994 | Phase 2 | Mar 31, 2025 | Centro Cardiologico Monzino IRCCS, Marche Polytechnic University, University of Naples Frederico II |
| NCT06856772 | Phase 4 | Feb 28, 2025 | University of Copenhagen |
| NCT06785974 | Phase 4 | Feb 28, 2025 | Amphia Hospital Breda, the Netherlands, Erasmus University Rotterdam |
Showing 20 of 933 trials
Page 1 / 47
Organizations
Research & Development (647)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Pfizer | For profit | 104 | 62 | 5 | 1997 |
| Merck | For profit | 55 | 50 | 4 | 2000 |
| AstraZeneca | For profit | 24 | 22 | 4 | 2001 |
| Chong Kun Dang Pharmaceutical | For profit | 24 | 24 | 4 | 2008 |
| Yonsei University | Academic/Hospital | 21 | 17 | 3 | 2007 |
| Regeneron | For profit | 20 | 3 | 4 | 2011 |
| Sanofi | For profit | 20 | 17 | 3 | 2008 |
| Capital Medical University | Academic/Hospital | 19 | 14 | 4 | 2009 |
| National Heart, Lung, and Blood Institute (NHLBI) | Government | 17 | 1 | 5 | 2001 |
| Seoul National University | Academic/Hospital | 14 | 6 | 3 | 2008 |
| Eli Lilly | For profit | 13 | 12 | 4 | 2005 |
| Harvard University | Academic/Hospital | 13 | 11 | 4 | 2004 |
| Peking University | Academic/Hospital | 12 | 7 | 4 | 2008 |
| Sungkyunkwan University | Academic/Hospital | 12 | 9 | 5 | 2006 |
| Aarhus University | Academic/Hospital | 11 | 9 | 3 | 2003 |
| National Cancer Institute (NCI) | Government | 10 | 3 | 3 | 2006 |
| Abbott | For profit | 9 | 7 | 4 | 2001 |
| Government of China | Government | 9 | 4 | 5 | 2006 |
| Jiao Tong University | Academic/Hospital | 9 | 8 | 3 | 2010 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 9 | 6 | 4 | 1999 |
647 organizations
Page 1 / 33
Marketing (43)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Accord Research | For profit | MKTG | Mar 30, 2018 |
| Agnitio | For profit | MKTG | Sep 2, 2021 |
| Alkem Labs Ltd | For profit | MKTG | Dec 21, 2018 |
| Apotex | For profit | MKTG | May 29, 2012 |
| Apotex | For profit | SYN | Nov 18, 2019 |
| August Bioservices | For profit | MKTG | Sep 2, 2021 |
| Biocon Limited | For profit | MKTG | Nov 23, 2022 |
| CMP Therapeutics Ltd | For profit | MKTG | Feb 1, 2023 |
| CMP Therapeutics Ltd | For profit | NDA2 | Feb 1, 2023 |
| Cipla | For profit | MKTG | Jan 9, 2017 |
| Dr. Reddy's Laboratories | For profit | MKTG | Jul 17, 2012 |
| Dr. Reddy's Laboratories | For profit | SYN | Mar 7, 2014 |
| Graviti Pharmaceuticals | For profit | MKTG | Jun 18, 2018 |
| Hetero Labs Ltd | For profit | MKTG | Sep 12, 2023 |
| Invagen Pharms | For profit | MKTG | Jan 9, 2017 |
| Lannett Company, Inc. | For profit | MKTG | Apr 5, 2013 |
| Lepu Medical Technology (Beijing) Co., Ltd. | For profit | MKTG | Nov 3, 2022 |
| Lupin | For profit | MKTG | Mar 6, 2019 |
| MSN Laboratories | For profit | SYN | Feb 8, 2019 |
| MSN Laboratories | For profit | MKTG | Feb 8, 2019 |
| Merck | For profit | MKTG | May 3, 2013 |
| Merck | For profit | NDA2 | May 3, 2013 |
| Micro Labs Ltd India | For profit | MKTG | Nov 7, 2019 |
| Mylan | For profit | SYN | Nov 29, 2013 |
| Mylan | For profit | MKTG | May 29, 2012 |
| Novartis | For profit | MKTG | May 29, 2012 |
| Organon | For profit | NDA2 | May 3, 2013 |
| Perrigo | For profit | MKTG | Jun 23, 2020 |
| Pfizer | For profit | NDA2 | Dec 17, 1996 |
| Pharmacia | For profit | NDA2 | Jan 30, 2004 |
| Pharmacia & Upjohn | For profit | NDA2 | Dec 17, 1996 |
| Pharmacia & Upjohn | For profit | NDA | Dec 17, 1996 |
| Sandoz | For profit | SYN | Apr 26, 2017 |
| Sandoz | For profit | MKTG | May 29, 2012 |
| Sciegen Pharmaceticals | For profit | MKTG | May 19, 2016 |
| Sun Pharmaceuticals | For profit | MKTG | Nov 30, 2011 |
| Teva | For profit | MKTG | May 29, 2012 |
| Teva | For profit | SYN | Mar 27, 2017 |
| Teva | For profit | SYN | Apr 26, 2017 |
| Thepharmanetwork Llc | For profit | MKTG | Dec 21, 2018 |
| Umedica Labs Pvt Ltd | For profit | MKTG | Aug 19, 2020 |
| Upjohn | For profit | MKTG | Dec 17, 1996 |
| Zydus Discovery DMCC | For profit | MKTG | Nov 20, 2018 |