carboplatin
Trade name: paraplatin
Small moleculeapproved
Approved
Mar 3, 1989
Carboplatin is an organoplatinum compound that possesses antineoplastic activity. Carboplatin is an intravenously administered platinum coordination complex and alkylating agent, which is used as a chemotherapeutic agent for the treatment of various cancers, mainly of advanced ovarian. Carboplatin is indicated for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with cisplatin. In addition this drug can be used to treat others cancers. Carboplatin therapy is associated with a low rate of transient serum aminotransferase elevations and with rare instances of clinically apparent liver injury. Carboplatin, like cisplatin, produces predominantly interstrand DNA cross-links rather than DNA-protein cross-links. This effect is apparently cell-cycle nonspecific. The aquation of carboplatin, which is thought to produce the active species, occurs at a slower rate than in the case of cisplatin. Despite this difference, it appears that both carboplatin and cisplatin induce equal numbers of drug-DNA cross-links, causing equivalent lesions and biological effects. — NCATS
Clinical trial activity
3,069 trials · 1,108 clinical orgs · 27 marketing orgs
Phase 1
730
Phase 2
2448
Phase 3
710
Phase 4
38
Earliest trial started Mar 1, 1988 (NCT00003093)
Timeline
1980s
- Jan 1, 1988
Earliest Phase 3 Sponsor(trial)
- Mar 3, 1989
Bristol-Myers Squibb — Earliest FDA Approval
- Mar 3, 1989
Bristol-Myers Squibb — NDA Organization
2000s
- Apr 16, 2003
Hospira — Marketing Organization
- Jul 14, 2003
Corden Pharma — NDA Secondary Org
- Oct 14, 2004
Pharmachemie Bv — Marketing Organization
- Oct 14, 2004
Fresenius — Marketing Organization
- Oct 14, 2004
Teva — Marketing Organization
- Oct 14, 2004
West-Ward Pharmaceutical — Marketing Organization
- Oct 14, 2004
Hikma — Marketing Organization
- Nov 16, 2004
Pliva — Marketing Organization
- Mar 18, 2005
Novartis — Marketing Organization
- Jun 14, 2005
Eu Yan Sang — Marketing Organization
- Jun 14, 2005
Meitheal — Marketing Organization
- Jan 27, 2006
Cipla — Marketing Organization
- Jan 18, 2007
TEYRO LABS — Marketing Organization
- Apr 24, 2007
Mylan — Marketing Organization
- May 8, 2008
Sandoz — Marketing Organization
- Sep 19, 2008
Sun Pharmaceuticals — Marketing Organization
- Dec 2, 2008
Barr Laboratories — Marketing Organization
- Jul 29, 2009
Akorn, Inc. — Marketing Organization
- Jul 29, 2009
Epic Pharma Llc — Marketing Organization
2010s
- Feb 6, 2012
Actavis — Marketing Organization
- May 29, 2012
Natco Pharma — Marketing Organization
- Mar 28, 2016
Eugia Pharma — Marketing Organization
- Feb 9, 2017
Accord Research — Marketing Organization
- Feb 15, 2017
Gland Pharma Ltd — Marketing Organization
- Apr 26, 2017
Ingenus Pharmaceuticals — Marketing Organization
- Apr 26, 2017
Novast Labs — Marketing Organization
Indications
Approved for
Studied for
- Adenocarcinoma · Phase 4
- Adenocarcinoma, Bronchiolo-Alveolar · Phase 2
- Adenocarcinoma, Clear Cell · Phase 3
- Adenocarcinoma, Mucinous · Phase 3
- Adenocarcinoma of Lung · Phase 4
- Adrenocortical Carcinoma · Phase 1
- Anemia · Phase 3
- Angiogenesis Modulating Agents · Phase 2
- Anterior Cruciate Ligament Injuries · Phase 2
- Antineoplastic Agents · Phase 2
- Anus Neoplasms · Phase 2
- Appendix · Phase 1
- Artificial Intelligence · Phase 2
- Ascites · Phase 2
- Astrocytoma · Phase 3
- B7-H1 Antigen · Phase 1
- Basal Cell Nevus Syndrome · Phase 2
- Beckwith-Wiedemann Syndrome · Phase 3
- Bile Duct Neoplasms · Phase 2
- Biliary Tract Neoplasms · Phase 3
- Biomarkers · Phase 2
- Bone Marrow Diseases · Phase 2
- Bone Neoplasms · Phase 1/Phase 2
- Brain Neoplasms · Phase 3
- Brain Stem Neoplasms · Phase 2
- BRCA1 Protein · Phase 2
- Breast · Phase 1/Phase 2
- Breast Diseases · Phase 2
- Breast Neoplasms · Phase 4
- Breast Neoplasms, Male · Phase 2
- Brenner Tumor · Phase 3
- Bronchial Diseases · Phase 3
- Bronchial Neoplasms · Phase 3
- Burkitt Lymphoma · Phase 4
- Carboplatin · Phase 3
- Carcinoma · Phase 4
- Carcinoma, Adenoid Cystic · Phase 2
- Carcinoma, Adenosquamous · Phase 3
- Carcinoma, Bronchogenic · Phase 3
- Carcinoma, Embryonal · Phase 2
- Carcinoma, Endometrioid · Phase 2
- Carcinoma, Hepatocellular · Phase 3
- Carcinoma, Intraductal, Noninfiltrating · Phase 2
- Carcinoma, Islet Cell · Phase 1
- Carcinoma, Large Cell · Phase 4
- Carcinoma, Merkel Cell · Phase 2
- Carcinoma, Mucoepidermoid · Phase 1
- Carcinoma, Neuroendocrine · Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 4
- Carcinoma, Ovarian Epithelial · Phase 3
- Carcinoma, Pancreatic Ductal · Phase 1
- Carcinoma, Renal Cell · Phase 3
- Carcinoma, Small Cell · Phase 2
- Carcinoma, Squamous Cell · Phase 4
- Carcinoma, Transitional Cell · Phase 3
- Carcinoma, Verrucous · Phase 3
- Carcinosarcoma · Phase 2
- Castration · Phase 2
- Central Nervous System Neoplasms · Phase 3
- Chemoradiotherapy · Phase 3
- Chemotherapy, Adjuvant · Phase 3
- Chemotherapy, Cancer, Regional Perfusion · Phase 2
- Chest Wall Oscillation · Phase 2
- Child · Phase 2
- Cholangiocarcinoma · Phase 3
- Choriocarcinoma · Phase 3
- Choroid Plexus Neoplasms · Phase 3
- Circulating Tumor DNA · Phase 2
- Cisplatin · Phase 3
- Clonal Hematopoiesis · Phase 2
- Cognition Disorders · Phase 1/Phase 2
- Colonic Neoplasms · Phase 3
- Colorectal Neoplasms · Phase 3
- Colorectal Neoplasms, Hereditary Nonpolyposis · Early Phase 1
- Cytoreduction Surgical Procedures · Phase 2
- Deglutition Disorders · Phase 2
- Diabetes Insipidus · Phase 2
- Diabetes Mellitus, Type 2 · Phase 1
- Diffuse Intrinsic Pontine Glioma · Phase 1/Phase 2
- Digestive System Neoplasms · Phase 2
- DNA Mismatch Repair · Early Phase 1
- Drug-Related Side Effects and Adverse Reactions · Phase 3
- Drugs, Investigational · Phase 3
- Drug Therapy · Phase 2
- Drug Therapy, Combination · Phase 1/Phase 2
- Edema · Phase 2
- Endocrine System Diseases · Phase 2
- Endodermal Sinus Tumor · Phase 3
- Endometrial Neoplasms · Phase 3
- Ependymoma · Phase 3
- Epidermal Growth Factor · Phase 3
- Erb-b2 Receptor Tyrosine Kinases · Phase 3
- Erythema · Phase 2
- Esophageal Neoplasms · Phase 3
- Esophageal Squamous Cell Carcinoma · Phase 3
- Fallopian Tube Neoplasms · Phase 3
- Fallopian Tubes · Phase 1
- Fatigue · Phase 3
- Gallbladder Neoplasms · Phase 3
- Ganglioneuroblastoma · Phase 3
- Gastrinoma · Phase 1
- Gastrointestinal Stromal Tumors · Phase 2
- Gene Amplification · Phase 1/Phase 2
- General Surgery · Phase 2
- Genes, erbB-2 · Phase 3
- Genes, ras · Phase 1/Phase 2
- Genital Diseases, Female · Phase 3
- Genital Neoplasms, Female · Phase 3
- Geriatrics · Phase 1/Phase 2
- Germinoma · Phase 3
- Gestational Trophoblastic Disease · Phase 3
- Glioblastoma · Phase 3
- Glioma · Phase 3
- Gliosarcoma · Phase 2
- Glucagonoma · Phase 1
- Graft vs Host Disease · Phase 2
- Granulocyte-Macrophage Colony-Stimulating Factor · Phase 2
- Hamartoma · Phase 3
- Head and Neck Neoplasms · Phase 3
- Healthy Volunteers · Phase 1
- Hemoptysis · Phase 2
- Hepatoblastoma · Phase 3
- Hereditary Breast and Ovarian Cancer Syndrome · Phase 1
- HIV · Phase 2
- HIV Infections · Phase 2
- Hodgkin Disease · Phase 3
- Homologous Recombination · Phase 2
- Human papillomavirus 16 · Phase 2
- Human Papillomavirus Viruses · Phase 1
- Hypertrophy · Phase 3
- Hypopharyngeal Neoplasms · Phase 3
- Immune Checkpoint Inhibitors · Phase 2
- Immunotherapy · Phase 3
- Induction Chemotherapy · Phase 2
- Infections · Phase 1
- Inflammatory Breast Neoplasms · Phase 3
- Informed Consent · Phase 2
- Insulinoma · Phase 1
- Intestinal Neoplasms · Phase 2
- Intraocular Lymphoma · Phase 2
- Kidney Diseases · Phase 3
- Kidney Neoplasms · Phase 3
- Lapatinib · Phase 1/Phase 2
- Laryngeal Neoplasms · Phase 3
- Larynx · Phase 2
- Leiomyosarcoma · Phase 2
- Leukemia · Phase 2/Phase 3
- Leukemia, B-Cell · Phase 1/Phase 2
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 2
- Leukemia-Lymphoma, Adult T-Cell · Phase 2
- Leukemia, Monocytic, Acute · Phase 2
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive · Phase 1
- Leukemia, Myeloid, Acute · Phase 2
- Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative · Phase 2
- Leukemia, Myeloid, Chronic-Phase · Phase 1
- Leukemia, Myelomonocytic, Acute · Phase 2
- Leukemia, Myelomonocytic, Chronic · Phase 2
- Leydig Cell Tumor · Phase 1
- Lip Neoplasms · Phase 2
- Liver Failure · Phase 1
- Liver Neoplasms · Phase 3
- Lung Diseases · Phase 3
- Lung Neoplasms · Phase 4
- Lymphadenopathy · Phase 1/Phase 2
- Lymph Nodes · Phase 2
- Lymphoma · Phase 4
- Lymphoma, B-Cell · Phase 2
- Lymphoma, B-Cell, Marginal Zone · Phase 2
- Lymphoma, Follicular · Phase 2
- Lymphoma, Large B-Cell, Diffuse · Phase 4
- Lymphoma, Large-Cell, Anaplastic · Phase 2
- Lymphoma, Large-Cell, Immunoblastic · Phase 2
- Lymphoma, Mantle-Cell · Phase 2
- Lymphoma, Non-Hodgkin · Phase 4
- Lymphoma, Primary Cutaneous Anaplastic Large Cell · Phase 1
- Lymphoma, T-Cell · Phase 2
- Lymphoma, T-Cell, Peripheral · Phase 2
- Lymphomatoid Granulomatosis · Phase 2
- Male Urogenital Diseases · Phase 2
- Medulloblastoma · Phase 4
- Melanoma · Phase 3
- Mesothelioma · Phase 3
- Mesothelioma, Malignant · Phase 2
- Mixed Tumor, Mesodermal · Phase 2
- Mixed Tumor, Mullerian · Phase 2
- Mouth Neoplasms · Phase 3
- Mucositis · Phase 2
- Multiple Myeloma · Phase 2
- Musculoskeletal Diseases · Phase 2
- Mutation · Phase 3
- Mycosis Fungoides · Phase 1
- Myelodysplastic-Myeloproliferative Diseases · Phase 2/Phase 3
- Myelodysplastic Syndromes · Phase 2/Phase 3
- Myeloproliferative Disorders · Phase 2/Phase 3
- Nasal Cavity · Phase 2
- Nasopharyngeal Carcinoma · Phase 4
- Nasopharyngeal Neoplasms · Phase 3
- Nausea · Phase 2
- Neoadjuvant Therapy · Phase 3
- Neoplasm Metastasis · Phase 3
- Neoplasm Recurrence, Local · Phase 2
- Neoplasm, Residual · Phase 2
- Neoplasms · Phase 4
- Neoplasms by Histologic Type · Phase 3
- Neoplasms by Site · Phase 3
- Neoplasms, Germ Cell and Embryonal · Phase 4
- Neoplasms, Glandular and Epithelial · Phase 2
- Neoplasms, Nerve Tissue · Phase 3
- Neoplasms, Second Primary · Phase 4
- Neoplasms, Squamous Cell · Phase 1/Phase 2
- Neoplasms, Unknown Primary · Phase 3
- Neuroblastoma · Phase 3
- Neuroectodermal Tumors · Phase 3
- Neuroectodermal Tumors, Primitive · Phase 2
- Neuroendocrine Tumors · Phase 4
- Neurofibromatosis 1 · Phase 3
- Neurotoxicity Syndromes · Phase 3
- Neutropenia · Phase 1
- Obesity · Phase 3
- Oligodendroglioma · Phase 2
- Oncogene Proteins · Phase 2
- Oncogenes · Phase 2
- Optic Nerve Glioma · Phase 2
- Oropharyngeal Neoplasms · Phase 3
- Osteosarcoma · Phase 2
- Ototoxicity · Phase 3
- Ovarian Diseases · Phase 3
- Paclitaxel · Phase 1
- Pain · Phase 3
- Pancoast Syndrome · Phase 2
- Pancreatic Neoplasms · Phase 2
- Papilloma · Phase 1
- Papillomaviridae · Phase 2
- Papillomavirus Infections · Phase 2
- Paranasal Sinuses · Phase 2
- Paranasal Sinus Neoplasms · Phase 2
- Patient Reported Outcome Measures · Phase 2
- Pelvic Neoplasms · Phase 3
- Penile Neoplasms · Phase 2
- Peripheral Nerve Injuries · Phase 3
- Peritoneal Neoplasms · Phase 3
- Pharmacokinetics · Phase 1
- Pharmacological and Toxicological Phenomena · Phase 4
- Pharyngeal Neoplasms · Phase 2
- Pinealoma · Early Phase 1
- Platinum Compounds · Phase 3
- Pleural Effusion, Malignant · Phase 2
- Polycythemia Vera · Phase 2
- Positron Emission Tomography Computed Tomography · Phase 2
- Postoperative Complications · Phase 2
- Precancerous Conditions · Phase 1/Phase 2
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma · Phase 2
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 2
- Primary Myelofibrosis · Phase 2
- Programmed Cell Death 1 Ligand 2 Protein · Phase 1
- Programmed Cell Death 1 Receptor · Phase 1
- Progression-Free Survival · Phase 3
- Prostatic Neoplasms · Phase 3
- Prostatic Neoplasms, Castration-Resistant · Phase 3
- Prosthesis Failure · Phase 2
- Protein Kinase Inhibitors · Phase 1/Phase 2
- Proto-Oncogene Proteins c-met · Phase 2
- Pseudomyxoma Peritonei · Phase 1
- Quality of Life · Phase 3
- Radiation Exposure · Phase 3
- Radiation Oncology · Phase 2
- Radiosurgery · Phase 2
- Radiotherapy · Phase 3
- ras GTPase-Activating Proteins · Phase 1
- ras Proteins · Phase 1
- Rectal Neoplasms · Phase 3
- Recurrence · Phase 2
- Renal Colic · Phase 2
- Renal Insufficiency · Phase 1
- Respiratory Tract Diseases · Phase 3
- Respiratory Tract Neoplasms · Phase 3
- Retinal Neoplasms · Phase 3
- Retinoblastoma · Phase 4
- Rhabdoid Tumor · Phase 3
- Rhabdomyosarcoma · Phase 3
- Risk Factors · Phase 2
- Rocky Mountain Spotted Fever · Phase 3
- Safety · Phase 2
- Salivary Gland Neoplasms · Phase 3
- Sarcoma · Phase 3
- Sarcoma, Clear Cell · Phase 2
- Sarcoma, Ewing · Phase 2
- Seminoma · Phase 3
- Sepsis · Phase 1/Phase 2
- Sezary Syndrome · Phase 2
- Skin Diseases · Phase 2
- Skin Neoplasms · Phase 3
- Small Cell Lung Carcinoma · Phase 4
- Somatostatinoma · Phase 1
- Squamous Cell Carcinoma of Head and Neck · Phase 4
- Stomach Neoplasms · Phase 3
- Teratoma · Phase 3
- Testicular Neoplasms · Phase 3
- Therapeutics · Phase 2
- Thoracic Neoplasms · Phase 3
- Thrombocythemia, Essential · Phase 2
- Thrombocytopenia · Phase 2
- Thymoma · Phase 2
- Thyroid Carcinoma, Anaplastic · Phase 3
- Thyroid Neoplasms · Phase 2
- Tissue Adhesions · Phase 2
- Tongue Neoplasms · Phase 3
- Triple Negative Breast Neoplasms · Phase 4
- Tumor Virus Infections · Phase 1
- Ureteral Neoplasms · Phase 2
- Urethral Neoplasms · Phase 3
- Urinary Bladder Neoplasms · Phase 3
- Urogenital Neoplasms · Phase 2
- Urologic Neoplasms · Phase 2
- Uterine Cervical Diseases · Phase 2
- Uterine Cervical Neoplasms · Phase 3
- Uterine Diseases · Phase 2
- Uterine Neoplasms · Phase 3
- Vaginal Neoplasms · Phase 1
- Venous Thromboembolism · Phase 1
- Vipoma · Phase 1
- Vomiting · Phase 2
- Vulvar Neoplasms · Phase 2
- Waldenstrom Macroglobulinemia · Phase 2
- Wilms Tumor · Phase 3
- Xerostomia · Phase 2
Mechanism of action
- DNAINHIBITOR
DNA inhibitor
Approval history
- approvedPriority reviewMar 3, 1989
Chemistry & pharmacology
Loading structure…
SMILES
N.N.[Pt++].[O-]C(=O)C1(CCC1)C([O-])=O- Mol. weight
- 371.254 g/mol
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Black box warning
Sources
- WikipediaCarboplatin ↗
- NCATSBG3F62OND5 ↗
- ChEMBLCHEMBL1351 ↗
Also known as
- carboplatin
- carboplatin
- carboplatin
- carboplatin
- carboplatin
- carboplatin
- carboplatin
- carboplatin
- carboplatin and paclitaxel
- cbdca
- cbdca
- cis-(1,1-cyclobutanedicarboxylato)diammineplatinum(ii)
- cis-(1,1-cyclobutanedicarboxylato)diammineplatinum(ii)
- cis-diammine(1,1-cyclobutanedicarboxylato)platinum
- cis-diammine(1,1-cyclobutanedicarboxylato)platinum
- cis-diammine(1,1-cyclobutanedicarboxylato)platinum(ii)
- cis-diammine(1,1-cyclobutanedicarboxylato)platinum(ii)
- jm-8
- jm-8
- paraplatin
- paraplatin
- paraplatin
- paraplatin
- paraplatin
- paraplatin
- paraplatin
- paraplatin
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07300475 | Phase 1 | Mar 31, 2026 | Washington University in St. Louis |
| NCT07290621 | Phase 2 | Feb 28, 2026 | University of Chicago |
| NCT07281417 | Phase 2 | Feb 27, 2026 | National Cancer Institute (NCI), Ohio State University |
| NCT07307443 | Phase 2 | Feb 1, 2026 | Chinese Academy of Medical Sciences, Hebei University, Peking University |
| NCT07065630 | Phase 2 | Jan 17, 2026 | University of Chicago |
| NCT07279935 | Phase 4 | Jan 15, 2026 | AstraZeneca |
| NCT07252739 | Phase 2 | Jan 14, 2026 | Merck |
| NCT07311577 | Phase 2 | Jan 1, 2026 | Jiangsu Cancer Institute & Hospital |
| NCT06999980 | Phase 2 | Dec 31, 2025 | Bristol-Myers Squibb, Melanoma Institute Australia |
| NCT07268040 | Phase 2 | Dec 31, 2025 | Hengrui Therapeutics, Inc. |
| NCT07283692 | Phase 2 | Dec 31, 2025 | Jiao Tong University |
| NCT07141771 | Phase 1/Phase 2 (Phase 2) | Dec 31, 2025 | Chinese Academy of Medical Sciences |
| NCT07309952 | Phase 2 | Dec 31, 2025 | Sun Yat-Sen University |
| NCT07296809 | Phase 2 | Dec 20, 2025 | Shantou University, Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. |
| NCT07310784 | Phase 2 | Dec 16, 2025 | Government of China |
| NCT07287995 | Phase 1/Phase 2 (Phase 2) | Dec 15, 2025 | Astellas |
| NCT07198074 | Phase 3 | Dec 15, 2025 | National Cancer Institute (NCI), NRG Oncology |
| NCT07246317 | Phase 2 | Dec 15, 2025 | Tianjin Medical University |
| NCT07227597 | Phase 1/Phase 2 (Phase 2) | Dec 12, 2025 | Daiichi Sankyo, Merck |
| NCT07155174 | Phase 2/Phase 3 (Phase 3) | Dec 6, 2025 | AbbVie |
Showing 20 of 3,069 trials
Page 1 / 154
Organizations
Research & Development (1,108)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| National Cancer Institute (NCI) | Government | 543 | 229 | 4 | 1988 |
| Merck | For profit | 135 | 71 | 4 | 1999 |
| AstraZeneca | For profit | 119 | 68 | 4 | 2000 |
| Roche | For profit | 94 | 61 | 4 | 2004 |
| Bristol-Myers Squibb | For profit | 90 | 41 | 3 | 1998 |
| University of Texas at Houston | Academic/Hospital | 86 | 70 | 4 | 1997 |
| Genentech | For profit | 85 | 17 | 4 | 2000 |
| Sun Yat-Sen University | Academic/Hospital | 85 | 62 | 5 | 2006 |
| Eli Lilly | For profit | 83 | 51 | 4 | 2000 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 68 | 47 | 5 | 2002 |
| Fudan University | Academic/Hospital | 57 | 44 | 4 | 2007 |
| Jiao Tong University | Academic/Hospital | 51 | 34 | 5 | 2007 |
| Cornell University | Academic/Hospital | 48 | 40 | 3 | 1991 |
| Harvard University | Academic/Hospital | 48 | 38 | 4 | 1996 |
| NRG Oncology | Academic/Hospital | 46 | 9 | 4 | 1998 |
| Huazhong University of Science and Technology | Academic/Hospital | 39 | 23 | 4 | 2008 |
| Mayo Clinic | Academic/Hospital | 39 | 8 | 3 | 1995 |
| Novartis | For profit | 39 | 18 | 4 | 2002 |
| Sanofi | For profit | 39 | 20 | 4 | 2001 |
| SCRI Development Innovations | For profit | 39 | 37 | 3 | 1998 |
1,108 organizations
Page 1 / 56
Marketing (35)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Accord Research | For profit | MKTG | Feb 9, 2017 |
| Actavis | For profit | MKTG | Feb 6, 2012 |
| Akorn, Inc. | For profit | MKTG | Jul 29, 2009 |
| Barr Laboratories | For profit | MKTG | Dec 2, 2008 |
| Bristol-Myers Squibb | For profit | NDA | Mar 3, 1989 |
| Cipla | For profit | MKTG | Jan 27, 2006 |
| Corden Pharma | For profit | NDA2 | Jul 14, 2003 |
| Corden Pharma | For profit | SYN | Mar 3, 1989 |
| Epic Pharma Llc | For profit | MKTG | Jul 29, 2009 |
| Eu Yan Sang | For profit | MKTG | Jun 14, 2005 |
| Eugia Pharma | For profit | MKTG | Mar 28, 2016 |
| Fresenius | For profit | MKTG | Oct 14, 2004 |
| Gland Pharma Ltd | For profit | MKTG | Feb 15, 2017 |
| Hikma | For profit | SYN | Oct 14, 2004 |
| Hikma | For profit | MKTG | Oct 14, 2004 |
| Hospira | For profit | MKTG | Apr 16, 2003 |
| Ingenus Pharmaceuticals | For profit | MKTG | Apr 26, 2017 |
| Meitheal | For profit | MKTG | Jun 14, 2005 |
| Mylan | For profit | MKTG | Apr 24, 2007 |
| Mylan | For profit | SYN | Nov 9, 2011 |
| Natco Pharma | For profit | MKTG | May 29, 2012 |
| Novartis | For profit | MKTG | Mar 18, 2005 |
| Novast Labs | For profit | MKTG | Apr 26, 2017 |
| Pharmachemie Bv | For profit | MKTG | Oct 14, 2004 |
| Pliva | For profit | MKTG | Nov 16, 2004 |
| Pliva | For profit | SYN | Dec 2, 2008 |
| Sandoz | For profit | SYN | Mar 18, 2005 |
| Sandoz | For profit | MKTG | May 8, 2008 |
| Sun Pharmaceuticals | For profit | MKTG | Sep 19, 2008 |
| Sun Pharmaceuticals | For profit | SYN | Sep 19, 2008 |
| TEYRO LABS | For profit | MKTG | Jan 18, 2007 |
| Teva | For profit | SYN | Mar 30, 2007 |
| Teva | For profit | SYN | Sep 21, 2005 |
| Teva | For profit | MKTG | Oct 14, 2004 |
| West-Ward Pharmaceutical | For profit | MKTG | Oct 14, 2004 |