oxycodone
Trade name: oxycontin
Approved
Apr 12, 1950
Oxycodone/paracetamol, sold under the brand name Percocet among others, is a fixed-dose combination of the opioid oxycodone with paracetamol (acetaminophen), used to treat moderate to severe pain. — Wikipedia
Clinical trial activity
456 trials · 284 clinical orgs · 70 marketing orgs
Earliest trial started Aug 1, 1995 (NCT00000273)
Timeline
1950s
- Apr 12, 1950
Earliest FDA Approval
- Apr 12, 1950
Endo Pharmaceuticals — Marketing Organization
- Apr 12, 1950
Endo Pharmaceuticals — NDA Secondary Org
1970s
- Oct 25, 1977
Bristol-Myers Squibb — Marketing Organization
1980s
- Feb 25, 1980
Hikma — Marketing Organization
- Feb 25, 1980
West-Ward Pharmaceutical — Marketing Organization
- Nov 2, 1981
Barr Laboratories — Marketing Organization
- May 13, 1982
Johnson and Johnson — Marketing Organization
- Jun 4, 1982
Roxane Laboratories — NDA Secondary Org
- Jun 4, 1982
Boehringer Ingelheim — Marketing Organization
- Jul 1, 1982
Halsey — Marketing Organization
- Dec 7, 1983
Specgx Llc — NDA Secondary Org
- Dec 7, 1983
Specgx Llc — Marketing Organization
1990s
- Jan 1, 1995
Earliest Phase 2 Sponsor(trial)
- Jul 30, 1996
Vintage — Marketing Organization
- Jan 1, 1997
Purdue Pharmaceuticals — Earliest Phase 3 Sponsor(trial)
- Oct 30, 1997
Watson Pharmaceuticals — Marketing Organization
- Jan 22, 1998
Mutual Pharmaceutical — Marketing Organization
- Jun 30, 1998
Duramed Research — Marketing Organization
- Aug 4, 1998
Mallinckrodt — Marketing Organization
- Aug 4, 1998
International Minerals and Chemical Corporation — Marketing Organization
- Oct 26, 1998
Boehringer Ingelheim — NDA Secondary Org
- Dec 30, 1998
Actavis — Marketing Organization
2000s
- Jan 1, 2003
Mallinckrodt — Earliest Phase 1 Sponsor(trial)
- Sep 4, 2003
Impax Laboratories — Marketing Organization
- Sep 29, 2003
Teva — Marketing Organization
- Nov 26, 2004
Forest Laboratories — Marketing Organization
- Nov 26, 2004
Forest Laboratories — NDA Secondary Org
- Dec 8, 2005
Nesher Pharms — Marketing Organization
- Dec 30, 2005
Mikart — Marketing Organization
- Jan 31, 2007
Strides Pharma Science — Marketing Organization
- Nov 27, 2007
Amneal Pharmaceuticals — Marketing Organization
- Oct 20, 2008
Mayne Pharma — Marketing Organization
- Oct 20, 2008
Dr. Reddy's Laboratories — Marketing Organization
- Apr 10, 2009
Sun Pharmaceuticals — Marketing Organization
- Aug 24, 2009
Epic Pharma Llc — Marketing Organization
- Aug 31, 2009
Avanthi Pharma — Marketing Organization
2010s
- Apr 5, 2010
Purdue Pharmaceuticals — NDA Secondary Org
- Oct 20, 2010
Genus Oncology, LLC — NDA Secondary Org
- Mar 9, 2011
Rhodes Pharmaceuticals, L.P. — Marketing Organization
- Jun 17, 2011
Zyla Life Sciences — NDA Secondary Org
- Jun 17, 2011
Zyla Life Sciences — Marketing Organization
- Dec 30, 2011
Alvogen — Marketing Organization
- Jan 12, 2012
VistaPharm, Inc. — NDA Secondary Org
- Jul 30, 2012
VistaPharm, Inc. — Marketing Organization
- Nov 19, 2012
Aurobindo Pharma — Marketing Organization
- Jul 11, 2013
Apax Partners — Marketing Organization
- Mar 11, 2014
International Minerals and Chemical Corporation — NDA Secondary Org
- Aug 1, 2014
Lannett Company, Inc. — Marketing Organization
- Apr 29, 2015
Novel Anti-Infective Technologies, LLC — Marketing Organization
- Jun 1, 2015
Ani Pharmaceuticals — Marketing Organization
- Jun 16, 2015
Wockhardt — Marketing Organization
- Jun 16, 2015
Xttrium Laboratories — Marketing Organization
- Apr 12, 2016
Nuvo Research Inc. — Marketing Organization
- Apr 26, 2016
Collegium Pharmaceutical, Inc. — NDA Secondary Org
- Aug 19, 2016
Pfizer — Marketing Organization
- Aug 19, 2016
Pfizer — NDA Secondary Org
- Sep 27, 2016
Allergan PLC (2015) — Marketing Organization
- Nov 23, 2016
Wes Pharma Inc — Marketing Organization
- Nov 23, 2016
Eywa Pharma — Marketing Organization
- Dec 13, 2016
Exeltis — Marketing Organization
- Dec 13, 2016
Cerovene — Marketing Organization
- Mar 22, 2017
Ascent Pharmahealth — Marketing Organization
- Apr 20, 2017
Daiichi Sankyo — NDA Secondary Org
- Apr 20, 2017
Ohemo Life — Marketing Organization
- Apr 20, 2017
Inspirion Delivery — Marketing Organization
- Apr 20, 2017
PROTEGA PHARMS — Marketing Organization
- Apr 20, 2017
PROTEGA PHARMS — NDA Secondary Org
- Jul 21, 2017
Abhai LLC — Marketing Organization
- Aug 7, 2017
Hi Tech Pharmaceuticals — Marketing Organization
- Aug 7, 2017
Akorn, Inc. — Marketing Organization
- Aug 15, 2017
Pharmaceutical Associates — Marketing Organization
- Dec 28, 2017
Zydus Discovery DMCC — Marketing Organization
- Apr 30, 2018
Mallinckrodt (2013) — Marketing Organization
- Jul 2, 2018
Nostrum Laboratories — Marketing Organization
- Jul 2, 2018
Elite Laboratories, Inc — Marketing Organization
- Nov 27, 2018
Nautic Partners — Marketing Organization
- Feb 4, 2019
Alkem Labs Ltd — Marketing Organization
- Aug 15, 2019
Chartwell Pharmaceuticals — Marketing Organization
- Aug 15, 2019
ANDA Repository — Marketing Organization
- Oct 31, 2019
Granules India — Marketing Organization
2020s
- Jun 2, 2021
Quagen Pharma — Marketing Organization
Indications
Studied for
- Abdominal Neoplasms · Phase 2
- Abortion, Induced · Phase 4
- Acute Pain · Phase 4
- Affective Symptoms · Phase 4
- alpha 1-Antitrypsin Deficiency · Phase 1
- Analgesia · Phase 4
- Analgesia, Epidural · Phase 4
- Analgesia, Patient-Controlled · Phase 4
- Analgesics, Opioid · Phase 4
- Anesthesia · Phase 2/Phase 3
- Anesthesia and Analgesia · Phase 3
- Anesthesia, Local · Phase 4
- Anesthesia Recovery Period · Phase 4
- Ankle Injuries · Phase 3
- Anterior Cruciate Ligament Injuries · Phase 4
- Anterior Cruciate Ligament Reconstruction · Phase 4
- Anti-Inflammatory Agents, Non-Steroidal · Phase 4
- Anxiety · Phase 4
- Anxiety Disorders · Phase 1
- Arthralgia · Phase 3
- Arthritis · Phase 4
- Arthrodesis · Phase 1
- Arthropathy, Neurogenic · Phase 4
- Arthroplasty · Phase 4
- Arthroplasty, Replacement, Hip · Phase 4
- Arthroplasty, Replacement, Knee · Early Phase 1
- Arthroscopy · Phase 4
- Back Pain · Phase 4
- Behavior, Addictive · Early Phase 1
- Blood Pressure · Phase 4
- Body Weight Changes · Phase 4
- Brachial Plexus Block · Phase 3
- Brain Injuries · Phase 2
- Breast Diseases · Phase 3
- Breast Neoplasms · Phase 4
- Bunion · Phase 3
- Burns · Phase 4
- Caffeine · Phase 3
- Cancer Pain · Phase 4
- Cannabis · Phase 4
- Carcinoma, Hepatocellular · Phase 4
- Carpal Tunnel Syndrome · Phase 2
- Catheters · Phase 4
- Cesarean Section · Early Phase 1
- Chronic Pain · Phase 4
- Cognitive Dysfunction · Phase 4
- Colorectal Neoplasms · Phase 1
- Communication · Phase 2
- Consciousness Disorders · Phase 2
- Constipation · Phase 4
- Corneal Diseases · Phase 1
- Critical Illness · Phase 4
- Cystectomy · Phase 4
- Cystitis, Interstitial · Phase 2
- Deglutition · Phase 4
- Deglutition Disorders · Phase 2
- Depression · Phase 4
- Depressive Disorder · Phase 1
- De Quervain Disease · Phase 2
- Diabetic Neuropathies · Phase 3
- Drug Interactions · Phase 1/Phase 2
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Drugs, Investigational · Phase 4
- Dry Eye Syndromes · Phase 1
- Dupuytren Contracture · Phase 2
- Esophageal Achalasia · Phase 4
- Esophageal and Gastric Varices · Phase 4
- Esophagitis · Phase 2
- Flank Pain · Phase 4
- Fractures, Bone · Phase 4
- Ganglion Cysts · Phase 2
- General Surgery · Phase 4
- Genital Neoplasms, Female · Phase 3
- Hallux Valgus · Phase 3
- Healthy Volunteers · Phase 4
- Herbal · Early Phase 1
- Hernia · Phase 3
- Hernia, Abdominal · Phase 2
- Hernia, Inguinal · Phase 4
- Heroin Dependence · Phase 2
- Hypercapnia · Phase 1
- Hysterectomy · Phase 4
- Inflammation · Phase 4
- Intervertebral Disc Degeneration · Phase 4
- Intestinal Neoplasms · Phase 4
- Intestine, Large · Phase 4
- Intubation · Phase 4
- Joint Diseases · Phase 3
- Ketorolac · Phase 3
- Kidney Calculi · Phase 4
- Kidney Failure, Chronic · Phase 4
- Kidney Neoplasms · Phase 2
- Knee Injuries · Phase 4
- Labor Pain · Phase 4
- Liver Cirrhosis · Phase 1
- Low Back Pain · Phase 4
- Lung Neoplasms · Phase 2
- Lymphoma · Phase 3
- Lymphoma, Large B-Cell, Diffuse · Phase 2
- Mitral Valve · Phase 4
- Molar, Third · Early Phase 1
- Mucositis · Phase 3
- Multiple Myeloma · Phase 3
- Multiple Sclerosis · Phase 4
- Multiple Trauma · Phase 2
- Musculoskeletal Pain · Phase 4
- Myocardial Infarction · Phase 4
- Myoma · Phase 4
- Narcotic-Related Disorders · Phase 4
- Narcotics · Phase 4
- Nausea · Phase 4
- Neck Pain · Phase 3
- Neoplasm Metastasis · Phase 4
- Neoplasms · Phase 4
- Nephrolithiasis · Phase 4
- Neuralgia · Phase 4
- Oocyte Retrieval · Phase 4
- Opioid-Induced Constipation · Phase 4
- Opioid-Related Disorders · Phase 2
- Osteoarthritis · Phase 3
- Osteoarthritis, Hip · Phase 3
- Osteoarthritis, Knee · Phase 3
- Otorhinolaryngologic Diseases · Phase 4
- Oxycodone · Phase 4
- Pain Management · Phase 4
- Parkinson Disease · Phase 2/Phase 3
- Parotid Gland · Phase 2
- Pelvic Organ Prolapse · Phase 4
- Peripheral Nervous System Diseases · Phase 4
- Persistent Vegetative State · Phase 2
- Pharmacogenetics · Phase 4
- Pharmacokinetics · Phase 4
- Postoperative Complications · Phase 4
- Postoperative Hemorrhage · Phase 4
- Postoperative Nausea and Vomiting · Phase 4
- Postoperative Pain · Phase 4
- Pre-Eclampsia · Phase 2
- Pregnancy Complications · Phase 3
- Prostatic Hyperplasia · Phase 3
- Prostatic Neoplasms · Phase 4
- Pruritus · Phase 3
- Radiation Oncology · Phase 3
- Recreational Drug Use · Phase 1
- Remifentanil · Phase 4
- Renal Insufficiency · Phase 4
- Renal Insufficiency, Chronic · Phase 4
- Respiration, Artificial · Phase 4
- Respiratory Insufficiency · Phase 4
- Rotator Cuff Injuries · Phase 4
- Scoliosis · Phase 4
- Shoulder Pain · Phase 4
- Signs and Symptoms · Phase 3
- Sinusitis · Phase 4
- Sleep Apnea Syndromes · Phase 4
- Spinal Cord Injuries · Phase 4
- Spinal Diseases · Phase 4
- Spinal Injuries · Phase 4
- Spondylolisthesis · Phase 4
- Squamous Cell Carcinoma of Head and Neck · Phase 3
- Substance Abuse, Oral · Phase 4
- Substance-Related Disorders · Phase 4
- Substance Withdrawal Syndrome · Phase 3
- Surgery, Oral · Early Phase 1
- Tendon Injuries · Phase 4
- Terminally Ill · Phase 4
- Thoracic Injuries · Phase 2
- Tibial Meniscus Injuries · Phase 3
- Tonsillectomy · Phase 2
- Tooth Abnormalities · Phase 1
- Toothache · Phase 2
- Trigger Finger Disorder · Phase 2
- Ureteral Calculi · Phase 4
- Urethral Stricture · Phase 4
- Urinary Bladder, Overactive · Phase 4
- Urologic Diseases · Early Phase 1
- Visceral Pain · Phase 4
- Wounds and Injuries · Phase 2
Mechanism of action
- Mu opioid receptorAGONIST
OPRM agonist
Combination products
combunox
with ibuprofen
Also known as fdc of oxycodone 5 mg/ibuprofen 400 mg
percocet
with acetaminophen
Also known as oxycet, oxycodone 2.5/apap, oxycodone 5/apap, oxycodone and acetaminophen, pro-229, roxicet, roxilox, tylox, xartemis xr
percodan-demi
with acetylsalicylic acid
Also known as codoxy, oxycodone and aspirin, oxycodone and aspirin (half-strength), percodan, roxiprin
targiniq
with naloxone
troxyca er
with naltrexone
Approval history
- approvedApr 12, 1950
Chemistry & pharmacology
SMILES
COc1ccc2c3c1O[C@H]1C(=O)CC[C@@]4(O)[C@@H](C2)N(C)CC[C@]314.COc1ccc2c3c1O[C@H]1C(=O)CC[C@@]4(O)[C@@H](C2)N(C)CC[C@]314.O=C(O)c1ccc(C(=O)O)cc1- Mol. weight
- 796.87 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Discontinued
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL3989826 ↗
- NCATSVS2A96444Q ↗
- WikipediaOxycodone/paracetamol ↗
- WikipediaOxycodone ↗
- ChEMBLCHEMBL656 ↗
- NCATSCD35PMG570 ↗
- ChEMBLCHEMBL1200890 ↗
- ChEMBLCHEMBL1200611 ↗
Also known as
- (-)-14-hydroxydihydrocodeinone
- (-)-14-hydroxydihydrocodeinone
- 4,5alpha-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one
- 4,5alpha-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one
- 4,5-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one
- 4,5-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one
- 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one
- 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one
- abtard
- acetaminophen mixture with oxycodone hydrochloride
- acurox
- acurox
- apo-oxycodone
- aspirin-oxycodone hydrochloride-oxycodone terephthalate combination
- candox
- carexil
- dihydro-14-hydroxycodeinone
- dihydro-14-hydroxycodeinone
- dihydro-14-hydroxycodeinone
- dihydrohydroxycodeinone
- dihydrohydroxycodeinone
- dihydrohydroxycodeinone
- dihydrone
- dihydroxycodeinone
- dihydroxycodeinone
- dolocodon pr
- leveraxo
- longtec
- lynlor
- magnesium aluminum oxide oxycodone
- mnk-795
- morphine oxycodone
- oxecta
- oxecta
- oxeltra
- oxicodona
- oxicodona
- oxicon
- oxicone
- oxicone
- oxycodeinone
- oxycodone
- oxycodone
- oxycodone
- oxycodone
- oxycodone
- oxycodone
- oxycodone
- oxycodone
- oxycodone
- oxycodone-acetaminophen
- oxycodone hcl
- oxycodone hcl
- oxycodone hcl
- oxycodone hydrochloride
- oxycodone hydrochloride
- oxycodone hydrochloride
- oxycodone hydrochloride
- oxycodone hydrochloride
- oxycodone hydrochloride hydrate
- oxycodone terephthalate
- oxycodone terephthalate
- oxycodone terephthalate
- oxycodone terephthalate
- oxycodonum
- oxycodonum
- oxycontin
- oxycontin
- oxycontin
- oxycontin
- oxycontin
- oxycontin
- oxycontin
- oxylan
- oxylan
- oxymorphone 3-methyl ether
- oxyneo
- oxyneo
- oxynorm
- oxynorm
- oxynorm
- percocet
- percocet
- percocet
- percodan
- percodan
- percodan
- proladone
- reltebon
- roxicodone
- roxicodone
- roxicodone
- shortec
- targinact
- targinact
- targinact
- tylos
- zomestine
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07218549 | Phase 1 | May 1, 2026 | Baylor University |
| NCT07219888 | Phase 4 | Dec 1, 2025 | University of Louisville |
| NCT07153003 | Phase 4 | Dec 1, 2025 | Mayo Clinic |
| NCT07017452 | Phase 3 | Aug 31, 2025 | University of Manitoba |
| NCT07097038 | N/A | Jul 31, 2025 | Henan Provincal People's Hospital |
| NCT06973785 | Phase 3 | Jul 15, 2025 | The Cleveland Clinic |
| NCT07223450 | Phase 1 | Jun 12, 2025 | Food and Drug Administration, Institut Hospital del Mar d'Investigacions Mèdiques, University of Manchester |
| NCT06917118 | N/A | May 1, 2025 | University of Puerto Rico |
| NCT06897917 | Phase 4 | Apr 30, 2025 | Henan Medical University |
| NCT06602271 | Phase 3 | Mar 31, 2025 | Ensysce Biosciences |
| NCT06757140 | Phase 1/Phase 2 (Phase 2) | Feb 28, 2025 | National Institute on Drug Abuse (NIDA), University of Kentucky |
| NCT06665048 | N/A | Dec 1, 2024 | Shantou University, Shenzhen University |
| NCT06505187 | Phase 2 | Nov 30, 2024 | University of Wisconsin |
| NCT06669650 | Phase 4 | Sep 25, 2024 | University of Tennessee |
| NCT06534801 | N/A | Sep 1, 2024 | Shandong Province Qianfoshan Hospital |
| NCT06435949 | Early Phase 1 (Phase 1) | Jul 1, 2024 | Jiao Tong University |
| NCT06484192 | Phase 4 | Jun 28, 2024 | Thomas Jefferson University |
| NCT06444997 | Phase 4 | Jun 1, 2024 | Fudan University |
| NCT06370585 | Phase 1 | May 30, 2024 | Laboratorios Sophia S.A de C.V. |
| NCT06338865 | N/A | May 3, 2024 | Cedars-Sinai Medical Center |
Organizations
Research & Development (284)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Mundipharma | For profit | 38 | 36 | 4 | 2005 |
| Pfizer | For profit | 28 | 15 | 5 | 2006 |
| Purdue Pharmaceuticals | For profit | 18 | 17 | 2 | 1997 |
| Johnson and Johnson | For profit | 15 | 14 | 2 | 2006 |
| Grunenthal | For profit | 14 | 4 | 4 | 2006 |
| Cassava Sciences | For profit | 12 | 12 | 3 | 2006 |
| Thomas Jefferson University | Academic/Hospital | 12 | 12 | 3 | 2017 |
| Mallinckrodt | For profit | 11 | 9 | 3 | 2003 |
| National Institute on Drug Abuse (NIDA) | Government | 10 | 0 | 4 | 1995 |
| Yeshiva University | Academic/Hospital | 9 | 8 | 3 | 2012 |
| Harvard University | Academic/Hospital | 7 | 7 | 3 | 2008 |
| Case Western Reserve University | Academic/Hospital | 6 | 6 | 4 | 2017 |
| Columbia University | Academic/Hospital | 6 | 6 | 2 | 1995 |
| Ensysce Biosciences | For profit | 6 | 6 | 2 | 2016 |
| Leiden University | Academic/Hospital | 6 | 3 | 2 | 2020 |
| Mayo Clinic | Academic/Hospital | 6 | 5 | 3 | 2011 |
| Johns Hopkins University | Academic/Hospital | 5 | 3 | 3 | 2007 |
| Kuopio University Hospital | Academic/Hospital | 5 | 5 | 2 | 2009 |
| National Cancer Institute (NCI) | Government | 5 | 0 | 4 | 2006 |
| Pharmaceutical Research Associates, Inc. (PRA) | For profit | 5 | 0 | 1 | 2016 |
Marketing (94)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ANDA Repository | For profit | MKTG | Aug 15, 2019 |
| Abhai LLC | For profit | MKTG | Jul 21, 2017 |
| Actavis | For profit | MKTG | Dec 30, 1998 |
| Actavis | For profit | SYN | Mar 22, 2011 |
| Akorn, Inc. | For profit | MKTG | Aug 7, 2017 |
| Alkem Labs Ltd | For profit | MKTG | Feb 4, 2019 |
| Allergan PLC (2015) | For profit | MKTG | Sep 27, 2016 |
| Alvogen | For profit | SYN | Dec 30, 2011 |
| Alvogen | For profit | MKTG | Dec 30, 2011 |
| Amneal Pharmaceuticals | For profit | SYN | Nov 27, 2007 |
| Amneal Pharmaceuticals | For profit | MKTG | Nov 27, 2007 |
| Ani Pharmaceuticals | For profit | SYN | Feb 27, 1998 |
| Ani Pharmaceuticals | For profit | MKTG | Jun 1, 2015 |
| Apax Partners | For profit | MKTG | Jul 11, 2013 |
| Ascent Pharmahealth | For profit | MKTG | Mar 22, 2017 |
| Aurobindo Pharma | For profit | MKTG | Nov 19, 2012 |
| Avanthi Pharma | For profit | MKTG | Aug 31, 2009 |
| Barr Laboratories | For profit | MKTG | Nov 2, 1981 |
| Barr Laboratories | For profit | SYN | Nov 29, 2007 |
| Boehringer Ingelheim | For profit | NDA2 | Oct 26, 1998 |
| Boehringer Ingelheim | For profit | MKTG | Jun 4, 1982 |
| Bristol-Myers Squibb | For profit | MKTG | Oct 25, 1977 |
| Cerovene | For profit | MKTG | Dec 13, 2016 |
| Chartwell Pharmaceuticals | For profit | MKTG | Aug 15, 2019 |
| Chartwell Pharmaceuticals | For profit | SYN | Sep 10, 2014 |
| Collegium Pharmaceutical, Inc. | For profit | NDA2 | Apr 26, 2016 |
| Daiichi Sankyo | For profit | NDA2 | Apr 20, 2017 |
| Dr. Reddy's Laboratories | For profit | MKTG | Oct 20, 2008 |
| DuPont | For profit | NDA | — |
| Duramed Research | For profit | MKTG | Jun 30, 1998 |
| Elite Laboratories, Inc | For profit | MKTG | Jul 2, 2018 |
| Endo Pharmaceuticals | For profit | MKTG | Apr 12, 1950 |
| Endo Pharmaceuticals | For profit | NDA2 | Apr 12, 1950 |
| Epic Pharma Llc | For profit | MKTG | Aug 24, 2009 |
| Exeltis | For profit | MKTG | Dec 13, 2016 |
| Exeltis | For profit | SYN | Dec 13, 2016 |
| Eywa Pharma | For profit | MKTG | Nov 23, 2016 |
| Forest Laboratories | For profit | MKTG | Nov 26, 2004 |
| Forest Laboratories | For profit | NDA2 | Nov 26, 2004 |
| Genus Oncology, LLC | For profit | NDA2 | Oct 20, 2010 |
| Granules India | For profit | SYN | Oct 31, 2019 |
| Granules India | For profit | MKTG | Oct 31, 2019 |
| Halsey | For profit | MKTG | Jul 1, 1982 |
| Hi Tech Pharmaceuticals | For profit | MKTG | Aug 7, 2017 |
| Hikma | For profit | MKTG | Feb 25, 1980 |
| Hikma | For profit | SYN | Feb 25, 1980 |
| Impax Laboratories | For profit | MKTG | Sep 4, 2003 |
| Impax Laboratories | For profit | SYN | Dec 23, 2003 |
| Inspirion Delivery | For profit | MKTG | Apr 20, 2017 |
| International Minerals and Chemical Corporation | For profit | NDA2 | Mar 11, 2014 |
| International Minerals and Chemical Corporation | For profit | MKTG | Aug 4, 1998 |
| Johnson and Johnson | For profit | SYN | Dec 12, 1984 |
| Johnson and Johnson | For profit | MKTG | May 13, 1982 |
| Lannett Company, Inc. | For profit | MKTG | Aug 1, 2014 |
| Mallinckrodt | For profit | MKTG | Aug 4, 1998 |
| Mallinckrodt | For profit | SYN | Mar 11, 2014 |
| Mallinckrodt (2013) | For profit | MKTG | Apr 30, 2018 |
| Mayne Pharma | For profit | MKTG | Oct 20, 2008 |
| Mikart | For profit | MKTG | Dec 30, 2005 |
| Mikart | For profit | SYN | Nov 27, 2018 |
| Mutual Pharmaceutical | For profit | MKTG | Jan 22, 1998 |
| Nautic Partners | For profit | MKTG | Nov 27, 2018 |
| Nesher Pharms | For profit | MKTG | Dec 8, 2005 |
| Nostrum Laboratories | For profit | MKTG | Jul 2, 2018 |
| Novel Anti-Infective Technologies, LLC | For profit | MKTG | Apr 29, 2015 |
| Nuvo Research Inc. | For profit | MKTG | Apr 12, 2016 |
| Ohemo Life | For profit | MKTG | Apr 20, 2017 |
| PROTEGA PHARMS | For profit | MKTG | Apr 20, 2017 |
| PROTEGA PHARMS | For profit | NDA2 | Apr 20, 2017 |
| Pfizer | For profit | MKTG | Aug 19, 2016 |
| Pfizer | For profit | NDA2 | Aug 19, 2016 |
| Pharmaceutical Associates | For profit | MKTG | Aug 15, 2017 |
| Purdue Pharmaceuticals | For profit | NDA2 | Apr 5, 2010 |
| Quagen Pharma | For profit | MKTG | Jun 2, 2021 |
| Rhodes Pharmaceuticals, L.P. | For profit | MKTG | Mar 9, 2011 |
| Roxane Laboratories | For profit | NDA2 | Jun 4, 1982 |
| Specgx Llc | For profit | NDA2 | Dec 7, 1983 |
| Specgx Llc | For profit | MKTG | Dec 7, 1983 |
| Strides Pharma Science | For profit | MKTG | Jan 31, 2007 |
| Sun Pharmaceuticals | For profit | MKTG | Apr 10, 2009 |
| Sun Pharmaceuticals | For profit | SYN | May 26, 1982 |
| Teva | For profit | MKTG | Sep 29, 2003 |
| Vintage | For profit | MKTG | Jul 30, 1996 |
| Vintage | For profit | SYN | Aug 31, 1976 |
| VistaPharm, Inc. | For profit | NDA2 | Jan 12, 2012 |
| VistaPharm, Inc. | For profit | MKTG | Jul 30, 2012 |
| Watson Pharmaceuticals | For profit | MKTG | Oct 30, 1997 |
| Wes Pharma Inc | For profit | MKTG | Nov 23, 2016 |
| West-Ward Pharmaceutical | For profit | MKTG | Feb 25, 1980 |
| Wockhardt | For profit | MKTG | Jun 16, 2015 |
| Xttrium Laboratories | For profit | MKTG | Jun 16, 2015 |
| Zydus Discovery DMCC | For profit | MKTG | Dec 28, 2017 |
| Zyla Life Sciences | For profit | NDA2 | Jun 17, 2011 |
| Zyla Life Sciences | For profit | MKTG | Jun 17, 2011 |