celecoxib
Trade name: celebrex
Small moleculeapproved
Approved
Dec 31, 1998
Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body. Celecoxib is an analgesic that is FDA approved for the treatment of osteoarthritis，rheumatoid arthritis，juvenile rheumatoid arthritis, ankylosing, spondylitis, acute pain and primary dysmenorrhea. The mechanism of action of Celecoxib is believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of cyclooxygenase-2 (COX-2). Concomitant use of Celecoxib and analgesic doses of aspirin is not generally recommended. Concomitant use with Celecoxib may diminish the antihypertensive effect of ACE Inhibitors, Angiotensin Receptor Blockers (ARB), or BetaBlockers and can increase serum concentration and prolong half-life of digoxin. Common adverse reactions include hypertension, diarrhea, nausea and headache. — NCATS
Clinical trial activity
555 trials · 412 clinical orgs · 42 marketing orgs
Phase 1
115
Phase 2
298
Phase 3
113
Phase 4
105
Earliest trial started Jan 1, 1996 (NCT00152724)
Timeline
1990s
- Jan 1, 1998
Earliest Phase 1 Sponsor(trial)
- Dec 31, 1998
G D Searle — Earliest FDA Approval
- Dec 31, 1998
G D Searle — NDA Secondary Org
- Dec 31, 1998
Upjohn — Marketing Organization
- Dec 31, 1998
G D Searle — NDA Organization
- Dec 31, 1998
Pharmacia & Upjohn — NDA Secondary Org
- Jan 1, 1999
Earliest Phase 2 Sponsor(trial)
- Dec 23, 1999
Pharmacia — NDA Secondary Org
2000s
- Jan 1, 2000
Earliest Phase 3 Sponsor(trial)
2010s
- May 30, 2014
Mylan — Marketing Organization
- May 30, 2014
Teva — Marketing Organization
- May 30, 2014
PHARMOBEDIENT — Marketing Organization
- Oct 29, 2014
Lupin — Marketing Organization
- Feb 11, 2015
Watson Pharmaceuticals — Marketing Organization
- Feb 11, 2015
Actavis — Marketing Organization
- Jun 2, 2015
Apotex — Marketing Organization
- Aug 21, 2015
Alembic — Marketing Organization
- Sep 23, 2015
Cipla — Marketing Organization
- Dec 23, 2015
Torrent Pharmaceuticals Limited — Marketing Organization
- Feb 1, 2016
Aurobindo Pharma — Marketing Organization
- Mar 16, 2016
Macleods Pharmaceuticals, Ltd — Marketing Organization
- Mar 16, 2016
Neogen — Marketing Organization
- Apr 4, 2017
Jubilant Innovation Ltd. — Marketing Organization
- Jan 23, 2018
Shijiazhuang Pharma Group (CSPC) — Marketing Organization
- Apr 30, 2018
Micro Labs Ltd India — Marketing Organization
- May 31, 2018
Purple Biotech — NDA Secondary Org
- May 31, 2018
Amneal Pharmaceuticals — Marketing Organization
- May 31, 2018
Purple Biotech — Marketing Organization
- May 31, 2018
Coeptis — NDA Secondary Org
- Aug 7, 2019
Baheal Pharmaceutical — Marketing Organization
- Nov 14, 2019
Cadila Healthcare — Marketing Organization
- Nov 27, 2019
Umedica Labs Pvt Ltd — Marketing Organization
2020s
- Feb 25, 2020
Tianjin Tianyao Pharmaceuticals — Marketing Organization
- Mar 6, 2020
Yiling Pharmaceutical Inc. — Marketing Organization
- May 5, 2020
BioDelivery Sciences International — Marketing Organization
- May 5, 2020
Dr. Reddy's Laboratories — Marketing Organization
- May 5, 2020
Scilex Pharms Inc — Marketing Organization
- May 5, 2020
Sorrento Therapeutics, Inc. — NDA Secondary Org
- May 13, 2020
Nanjing Sike Pharmaceutical Co., Ltd. — Marketing Organization
- Dec 3, 2020
Sciegen Pharmaceticals — Marketing Organization
- Dec 9, 2020
Acic Pharmaceuticals — Marketing Organization
- Dec 9, 2020
PANGAEA — Marketing Organization
- Jan 12, 2021
Unichem — Marketing Organization
- Oct 15, 2021
Kowa — NDA Secondary Org
- Apr 10, 2023
Yabao Pharmaceutical Group — Marketing Organization
- Apr 29, 2025
Strides Pharma Science — Marketing Organization
- Jul 14, 2025
Zydus Discovery DMCC — Marketing Organization
- Jul 29, 2025
CARWIN PHARM ASSOC — Marketing Organization
Indications
Approved for
Studied for
- Acute Febrile Encephalopathy · Phase 2
- Acute Pain · Phase 3
- alpha-Mannosidosis · Phase 2
- Alzheimer Disease · Phase 3
- Amyotrophic Lateral Sclerosis · Phase 2
- Analgesia · Phase 3
- Analgesics · Phase 4
- Analgesics, Opioid · Phase 4
- Anemia · Phase 1
- Angioplasty, Balloon, Coronary · Phase 4
- Ankle Injuries · Phase 4
- Anterior Cruciate Ligament Injuries · Phase 3
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis · Phase 1
- Arthralgia · Phase 3
- Arthritis · Phase 4
- Arthritis, Gouty · Phase 3
- Arthropathy, Neurogenic · Phase 4
- Arthroplasty · Phase 2/Phase 3
- Arthroplasty, Replacement, Knee · Phase 4
- Arthroscopy · Phase 4
- Aspartylglucosaminuria · Phase 2
- Atrial Fibrillation · Phase 4
- Axial Spondyloarthritis · Phase 4
- Back Pain · Phase 4
- Bile Duct Neoplasms · Phase 4
- Bipolar Disorder · Phase 4
- Body Fat Distribution · Phase 1/Phase 2
- Bone and Bones · Phase 1
- Bone Resorption · Phase 1
- Brain Diseases · Phase 1
- Brain Neoplasms · Phase 2
- Breast Neoplasms · Phase 3
- Carcinoma · Phase 2
- Carcinoma, Hepatocellular · Phase 4
- Carcinoma, Mucoepidermoid · Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 3
- Carcinoma, Renal Cell · Phase 2
- Cardiovascular Diseases · Phase 4
- Celecoxib · Phase 3
- Central Serous Chorioretinopathy · Phase 1
- Cerebral Hemorrhage · Phase 2
- Cerebrovascular Disorders · Phase 3
- Cholecystectomy, Laparoscopic · Phase 3
- Chronic Pain · Phase 3
- Colonic Neoplasms · Phase 4
- Colorectal Neoplasms · Phase 4
- Colorectal Neoplasms, Hereditary Nonpolyposis · Phase 1
- Colposcopy · Phase 4
- Constipation · Phase 4
- Coronary Artery Disease · Phase 4
- Coronary Restenosis · Phase 4
- COVID-19 · Phase 2
- Crohn Disease · Phase 4
- Cyclooxygenase 2 Inhibitors · Phase 4
- Deficiency Diseases · Phase 2
- Depression · Phase 3
- Depression, Postpartum · Phase 3
- Diabetes Mellitus, Type 2 · Phase 2
- Diabetic Nephropathies · Phase 4
- Diabetic Retinopathy · Phase 4
- Diarrhea · Phase 1
- DNA Mismatch Repair · Phase 2
- Drug Interactions · Phase 1
- Drugs, Investigational · Phase 3
- Drug Therapy · Phase 2
- Duodenal Neoplasms · Phase 2/Phase 3
- Edema · Phase 1
- Endometrial Neoplasms · Phase 2
- Ependymoma · Phase 2
- Epiretinal Membrane · Phase 1
- Esophageal Neoplasms · Phase 2
- Esophageal Squamous Cell Carcinoma · Phase 2
- Facial Pain · Phase 2
- Fallopian Tube Neoplasms · Phase 2
- Food-Drug Interactions · Phase 2
- Fractures, Stress · Phase 1
- Fucosidosis · Phase 2
- General Surgery · Phase 4
- Genetic Diseases, Inborn · Phase 2
- Glioblastoma · Phase 2
- Glioma · Phase 2
- Graves Ophthalmopathy · Phase 2
- Growth and Development · Early Phase 1
- Hamartoma · Phase 2
- Hand Injuries · Phase 3
- Head and Neck Neoplasms · Phase 3
- Healthy Volunteers · Phase 4
- Heart · Phase 1
- Heart Diseases · Phase 3
- Hepatitis B · Phase 2
- Hepatolenticular Degeneration · Phase 1
- HLA-A2 Antigen · Phase 2
- Hodgkin Disease · Phase 1
- Hyperalgesia · Phase 2
- Hyperlipidemias · Phase 4
- Hypertension · Phase 4
- Hypopharyngeal Neoplasms · Phase 2
- Hypotension, Orthostatic · Phase 1
- Hysteroscopy · Phase 3
- Immune Checkpoint Inhibitors · Phase 2
- Inflammation · Phase 4
- Inflammatory Bowel Diseases · Phase 4
- Influenza, Human · Phase 3
- Intestinal Polyposis · Phase 4
- Intestinal Polyps · Phase 2/Phase 3
- Keratosis, Actinic · Phase 2/Phase 3
- Laryngeal Neoplasms · Phase 2
- Leiomyoma · Phase 4
- Leukemia · Phase 2
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 1
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive · Phase 1
- Leukemia, Myeloid, Acute · Phase 1
- Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative · Phase 1
- Leukemia, Myeloid, Chronic-Phase · Phase 1
- Leukemia, Myelomonocytic, Chronic · Phase 1
- Leukodystrophy, Globoid Cell · Phase 2
- Leukodystrophy, Metachromatic · Phase 2
- Ligaments · Phase 4
- Liver Neoplasms · Phase 3
- Low Back Pain · Phase 4
- Lung Diseases · Phase 4
- Lung Neoplasms · Phase 3
- Lymphangioleiomyomatosis · Phase 2
- Lymphoma · Phase 2
- Lymphoma, Non-Hodgkin · Phase 1
- Lymphoma, Primary Cutaneous Anaplastic Large Cell · Phase 1
- Macular Degeneration · Phase 3
- Magnetic Resonance Imaging · Phase 4
- Major Depressive Disorder · Phase 4
- Medulloblastoma · Phase 2
- Melanoma · Phase 2
- Memory Disorders · Phase 3
- Meniscus · Early Phase 1
- Mesothelioma · Phase 1/Phase 2
- Mesothelioma, Malignant · Phase 3
- Metabolic Diseases · Phase 2
- Metabolic Syndrome · Phase 4
- Microsatellite Instability · Phase 1
- Migraine Disorders · Phase 3
- Migraine with Aura · Phase 2
- Migraine without Aura · Phase 2
- Monoclonal Gammopathy of Undetermined Significance · Phase 2
- Mood Disorders · Phase 3
- Mouth Neoplasms · Phase 2/Phase 3
- Mucopolysaccharidoses · Phase 2
- Mucopolysaccharidosis I · Phase 2
- Mucopolysaccharidosis II · Phase 2
- Mucopolysaccharidosis VI · Phase 2
- Mucopolysaccharidosis VII · Phase 2
- Multiple Myeloma · Phase 2
- Musculoskeletal Pain · Phase 1
- Mutation · Phase 2
- Myelodysplastic Syndromes · Phase 1
- Myeloproliferative Disorders · Phase 1
- Myocardial Ischemia · Phase 4
- Myositis · Phase 1
- Narcotics · Phase 4
- Nasopharyngeal Carcinoma · Phase 3
- Nausea · Phase 4
- Neoadjuvant Therapy · Phase 2
- Neoplasm Metastasis · Phase 2
- Neoplasms, Germ Cell and Embryonal · Phase 1
- Neuralgia · Phase 2
- Neuroblastoma · Phase 2
- Neuroectodermal Tumors, Primitive · Early Phase 1
- Neurofibromatosis 1 · Phase 2
- Neuroinflammatory Diseases · Phase 4
- Obesity · Phase 4
- Obesity, Abdominal · Phase 4
- Obsessive-Compulsive Disorder · Phase 2
- Oropharyngeal Neoplasms · Phase 2
- Osteoarthritis, Hip · Phase 4
- Osteoarthritis, Knee · Phase 4
- Osteopetrosis · Phase 2
- Ovarian Neoplasms · Phase 2
- Overweight · Phase 4
- Pain Management · Phase 4
- Pancreatic Neoplasms · Phase 4
- Paranasal Sinus Neoplasms · Phase 1/Phase 2
- Paresthesia · Phase 3
- Parkinson Disease · Phase 1/Phase 2
- Parotid Gland · Phase 2
- Peptic Ulcer · Phase 4
- Peritoneal Neoplasms · Phase 1/Phase 2
- Peroxisomal Disorders · Phase 2
- Pharmacokinetics · Phase 4
- Pharyngeal Neoplasms · Phase 1/Phase 2
- Pharyngitis · Phase 3
- Photochemotherapy · Phase 1
- Pinealoma · Early Phase 1
- Polycystic Ovary Syndrome · Phase 4
- Postoperative Pain · Phase 4
- Precancerous Conditions · Phase 2/Phase 3
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma · Phase 1
- Pre-Eclampsia · Phase 2
- Pregabalin · Phase 2/Phase 3
- Primary Myelofibrosis · Phase 1
- Prostatic Hyperplasia · Phase 4
- Prostatic Neoplasms · Phase 2/Phase 3
- Prostatic Neoplasms, Castration-Resistant · Phase 1
- Prostatitis · Phase 4
- Psychiatry · Phase 2
- Pure Autonomic Failure · Phase 1
- Rectal Neoplasms · Phase 3
- Refsum Disease, Infantile · Phase 2
- Retinal Diseases · Phase 1
- Retinal Vein Occlusion · Phase 1
- Rhabdoid Tumor · Phase 2
- Rotator Cuff Injuries · Phase 4
- Sarcoma · Phase 2
- Schizophrenia · Phase 4
- Shoulder Injuries · Phase 4
- Shoulder Pain · Phase 4
- Sinusitis · Phase 4
- Sleep Apnea, Obstructive · Phase 1/Phase 2
- Small Cell Lung Carcinoma · Phase 1
- Smoking · Phase 3
- Smoldering Multiple Myeloma · Phase 2
- Sphingolipidoses · Phase 2
- Sphingomyelins · Phase 2
- Spinal Diseases · Phase 3
- Spinal Stenosis · Phase 4
- Spondylarthropathies · Phase 4
- Squamous Cell Carcinoma of Head and Neck · Phase 2
- Squamous Intraepithelial Lesions · Phase 2
- Stomach Neoplasms · Phase 2
- Stomach Ulcer · Phase 3
- Stomatitis · Phase 2
- Stroke · Phase 1/Phase 2
- Survival · Phase 2
- Temporomandibular Joint Disorders · Phase 2
- Thoracic Neoplasms · Phase 1/Phase 2
- Thymoma · Phase 1
- Thyroidectomy · Phase 4
- Thyroiditis, Subacute · Phase 3
- Tobacco Use Disorder · Phase 1/Phase 2
- Tongue Neoplasms · Phase 2
- Tonsillectomy · Phase 2
- Tonsillitis · Phase 2
- Triple Negative Breast Neoplasms · Phase 2
- Tuberculosis · Phase 1
- Ureteral Calculi · Phase 4
- Urethral Stricture · Phase 4
- Urinary Bladder Neoplasms · Phase 2/Phase 3
- Uterine Artery Embolization · Phase 4
- Uterine Cervical Neoplasms · Phase 2
- Uterine Neoplasms · Phase 2
- Vascular Diseases · Phase 4
- Vascular Surgical Procedures · Phase 3
- Venous Cutdown · Phase 4
- Vitreous Body · Phase 1
- Zellweger Syndrome · Phase 2
Mechanism of action
- Cyclooxygenase-2INHIBITOR
PTGS2 inhibitor
Combination products
consensi
with amlodipine
seglentis
with tramadol
Approval history
- approvedPriority reviewDec 31, 1998
Chemistry & pharmacology
Loading structure…
SMILES
CC1=CC=C(C=C1)C2=CC(=NN2C3=CC=C(C=C3)S(N)(=O)=O)C(F)(F)F- Mol. weight
- 381.372 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Black box warning
Sources
- WikipediaCelecoxib ↗
- NCATSJCX84Q7J1L ↗
- ChEMBLCHEMBL19236 ↗
- ChEMBLCHEMBL1788385 ↗
- ChEMBLCHEMBL118 ↗
Also known as
- (2r,4r)-1-[(2s)-5-[(aminoiminomethyl)amino]-1-oxo-2-[[(1,2,3,4-tetrahydro-3-methyl-8- quinolinyl)sulfonyl]amino]pentyl]-4-methyl-2-piperidinecarboxylic acid
- (2r,4r)-1-[(2s)-5-[(aminoiminomethyl)amino]-1-oxo-2-[[(1,2,3,4-tetrahydro-3-methyl-8- quinolinyl)sulfonyl]amino]pentyl]-4-methyl-2-piperidinecarboxylic acid
- 4-chloro-n-(4,5-dihydro-1h-imidazol-2-yl)-6-methoxy-2-methyl-5-pyrimidinamine
- bdf5896
- bdf5896
- be5895
- be5895
- be 5895
- be-5895
- celebra
- celebra
- celebrex
- celebrex
- celebrex
- celebrex
- celebrex
- celecox
- celecoxb
- celecoxib
- celecoxib
- celecoxib
- celecoxib
- celecoxib
- celecoxib
- celecoxib
- celecoxib
- celecoxib
- celecoxib
- celecoxib
- celecoxib
- celecoxib
- célécoxib
- célécoxib
- celecoxibum
- celecoxibum
- celocoxib
- cynt
- cynt
- cynt
- dfd07
- fisiotens
- lilly brand of moxonidine
- moxon
- moxonidin
- moxonidin
- moxonidine
- moxonidine
- moxonidine
- moxonidine
- moxonidine
- moxonidine
- moxonidine
- moxonidine
- norcynt
- norcynt
- normatens
- normatens
- normatens
- normoxocin
- onsenal
- onsenal
- onsenal
- p-(5-p-tolyl-3-(trifluoromethyl)pyrazol-1-yl)benzenesulfonamide
- p-(5-p-tolyl-3-(trifluoromethyl)pyrazol-1-yl)benzenesulfonamide
- physiotens
- physiotens
- physiotens
- sc-58635
- sc-58635
- solvay brand of moxonidine
- zint
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07139405 | Phase 2 | Feb 28, 2026 | Myopharm Limited |
| NCT07174570 | Phase 2 | Nov 28, 2025 | Emory University, National Cancer Institute (NCI) |
| NCT07246278 | Phase 1/Phase 2 (Phase 2) | Nov 20, 2025 | Tanta University |
| NCT06942039 | Early Phase 1 (Phase 1) | Sep 30, 2025 | C17 Council |
| NCT07171034 | Phase 1 | Sep 1, 2025 | Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. |
| NCT07150949 | Phase 2 | Aug 28, 2025 | Fudan University |
| NCT07104266 | Phase 2 | Aug 4, 2025 | University of Sherbrooke |
| NCT07154316 | Phase 2 | Aug 1, 2025 | Anyang Regional Hospital, Cancer Hospital of Yunnan provinceal, Fudan University, Fujian Medical University, Shandong first medical University |
| NCT07049185 | Phase 2 | Jul 15, 2025 | Peking University |
| NCT06997068 | Phase 2 | Jul 9, 2025 | Mayo Clinic |
| NCT06699966 | Phase 4 | Jun 30, 2025 | Stony Brook University |
| NCT06903858 | Phase 2 | Apr 1, 2025 | Sun Yat-Sen University |
| NCT06722534 | N/A | Jan 1, 2025 | Air Force Military Medical University, China |
| NCT06505187 | Phase 2 | Nov 30, 2024 | University of Wisconsin |
| NCT06337422 | Phase 1 | Sep 23, 2024 | Mahidol University |
| NCT06863636 | Phase 3 | Sep 9, 2024 | Clinical Research Institute S.C., Consultorio Médico "Dr. Rodrigo Suárez Otero", Imacen S.A. de C.V., Laboratorios Silanes S.A. de C.V., Unidad de Medicina Especializada SMA |
| NCT06545526 | Phase 3 | Aug 13, 2024 | Yonsei University |
| NCT06451783 | Early Phase 1 (Phase 1) | May 1, 2024 | Shanghai Xuhui District Central Hospital |
| NCT06516094 | Phase 3 | Apr 11, 2024 | Consultorio Médico "Dr. Rodrigo Suárez Otero", Imacen S.A. de C.V., Laboratorios Silanes S.A. de C.V. |
| NCT06285617 | Phase 3 | Apr 1, 2024 | People's Liberation Army of China |
Showing 20 of 555 trials
Page 1 / 28
Organizations
Research & Development (412)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| National Cancer Institute (NCI) | Government | 93 | 26 | 4 | 1998 |
| Pfizer | For profit | 72 | 48 | 5 | 2000 |
| University of Texas at Houston | Academic/Hospital | 18 | 13 | 5 | 2000 |
| Seoul National University | Academic/Hospital | 13 | 9 | 5 | 2004 |
| Harvard University | Academic/Hospital | 12 | 9 | 3 | 2000 |
| Cairo University | Academic/Hospital | 9 | 9 | 4 | 2014 |
| Dr. Reddy's Laboratories | For profit | 9 | 8 | 3 | 2015 |
| Eli Lilly | For profit | 9 | 7 | 3 | 2003 |
| Sun Yat-Sen University | Academic/Hospital | 9 | 7 | 5 | 2007 |
| Vanderbilt University | Academic/Hospital | 9 | 8 | 3 | 2000 |
| State University of New York, Buffalo | Academic/Hospital | 8 | 8 | 3 | 2005 |
| University of California, Los Angeles | Academic/Hospital | 8 | 7 | 4 | 2000 |
| University of Pennsylvania | Academic/Hospital | 8 | 6 | 5 | 2007 |
| City of Hope National Medical Center | Academic/Hospital | 7 | 4 | 2 | 2001 |
| Cornell University | Academic/Hospital | 7 | 5 | 3 | 2000 |
| Northwestern University | Academic/Hospital | 7 | 6 | 3 | 2002 |
| University of Alabama, Birmingham | Academic/Hospital | 7 | 6 | 4 | 2001 |
| Department of Defense | Government | 6 | 0 | 1 | 2005 |
| Department of Veteran Affairs | Government | 6 | 5 | 3 | 2000 |
| NeuroSense Therapeutics Ltd. | For profit | 6 | 6 | 2 | 2019 |
412 organizations
Page 1 / 21
Marketing (53)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Acic Pharmaceuticals | For profit | MKTG | Dec 9, 2020 |
| Actavis | For profit | MKTG | Feb 11, 2015 |
| Alembic | For profit | MKTG | Aug 21, 2015 |
| Alembic | For profit | SYN | Aug 21, 2015 |
| Amneal Pharmaceuticals | For profit | MKTG | May 31, 2018 |
| Apotex | For profit | MKTG | Jun 2, 2015 |
| Apotex | For profit | SYN | Jun 2, 2015 |
| Aurobindo Pharma | For profit | SYN | Feb 1, 2016 |
| Aurobindo Pharma | For profit | MKTG | Feb 1, 2016 |
| Baheal Pharmaceutical | For profit | MKTG | Aug 7, 2019 |
| BioDelivery Sciences International | For profit | MKTG | May 5, 2020 |
| CARWIN PHARM ASSOC | For profit | MKTG | Jul 29, 2025 |
| Cadila Healthcare | For profit | MKTG | Nov 14, 2019 |
| Cipla | For profit | MKTG | Sep 23, 2015 |
| Coeptis | Government | NDA2 | May 31, 2018 |
| Dr. Reddy's Laboratories | For profit | SYN | May 5, 2020 |
| Dr. Reddy's Laboratories | For profit | MKTG | May 5, 2020 |
| G D Searle | For profit | NDA2 | Dec 31, 1998 |
| G D Searle | For profit | SYN | Dec 23, 1999 |
| G D Searle | For profit | NDA | Dec 31, 1998 |
| Jubilant Innovation Ltd. | For profit | MKTG | Apr 4, 2017 |
| Kowa | For profit | NDA2 | Oct 15, 2021 |
| Lupin | For profit | MKTG | Oct 29, 2014 |
| Macleods Pharmaceuticals, Ltd | For profit | MKTG | Mar 16, 2016 |
| Micro Labs Ltd India | For profit | MKTG | Apr 30, 2018 |
| Mylan | For profit | MKTG | May 30, 2014 |
| Mylan | For profit | SYN | May 30, 2014 |
| Nanjing Sike Pharmaceutical Co., Ltd. | For profit | MKTG | May 13, 2020 |
| Neogen | For profit | MKTG | Mar 16, 2016 |
| PANGAEA | For profit | MKTG | Dec 9, 2020 |
| PHARMOBEDIENT | For profit | MKTG | May 30, 2014 |
| Pharmacia | For profit | NDA2 | Dec 23, 1999 |
| Pharmacia & Upjohn | For profit | NDA2 | Dec 31, 1998 |
| Purple Biotech | For profit | NDA2 | May 31, 2018 |
| Purple Biotech | For profit | MKTG | May 31, 2018 |
| Sciegen Pharmaceticals | For profit | MKTG | Dec 3, 2020 |
| Scilex Pharms Inc | For profit | MKTG | May 5, 2020 |
| Scilex Pharms Inc | For profit | SYN | May 5, 2020 |
| Shijiazhuang Pharma Group (CSPC) | For profit | MKTG | Jan 23, 2018 |
| Sorrento Therapeutics, Inc. | For profit | NDA2 | May 5, 2020 |
| Strides Pharma Science | For profit | MKTG | Apr 29, 2025 |
| Teva | For profit | MKTG | May 30, 2014 |
| Tianjin Tianyao Pharmaceuticals | For profit | MKTG | Feb 25, 2020 |
| Torrent Pharmaceuticals Limited | For profit | MKTG | Dec 23, 2015 |
| Umedica Labs Pvt Ltd | For profit | MKTG | Nov 27, 2019 |
| Umedica Labs Pvt Ltd | For profit | SYN | Nov 27, 2019 |
| Unichem | For profit | MKTG | Jan 12, 2021 |
| Upjohn | For profit | MKTG | Dec 31, 1998 |
| Watson Pharmaceuticals | For profit | MKTG | Feb 11, 2015 |
| Yabao Pharmaceutical Group | For profit | MKTG | Apr 10, 2023 |
| Yiling Pharmaceutical Inc. | For profit | MKTG | Mar 6, 2020 |
| Yiling Pharmaceutical Inc. | For profit | SYN | Mar 6, 2020 |
| Zydus Discovery DMCC | For profit | MKTG | Jul 14, 2025 |