hydrochlorothiazide
Trade name: esidrix
Approved
Feb 12, 1959
CAPOZIDE (captopril and hydrochlorothiazide tablets, USP) for oral administration combines two antihypertensive agents: captopril and hydrochlorothiazide. The mechanism of action of captopril has not yet been fully elucidated. Captopril prevents the conversion of angiotensin I to angiotensin II by inhibition of ACE, a peptidyldipeptide carboxy hydrolase. Hydrochlorothiazide belongs to thiazide class of diuretics. It reduces blood volume by acting on the kidneys to reduce sodium (Na+) reabsorption in the distal convoluted tubule. CAPOZIDE (captopril and hydrochlorothiazide tablets, USP) is indicated for the treatment of hypertension. The blood pressure lowering effects of captopril and thiazides are approximately additive. Major side effects are: Black, tarry stools; chest pain; chills; cough; fever; painful or difficult urination; shortness of breath; sore throat; sores, ulcers, or white spots on lips or in mouth; swollen glands; unusual bleeding or bruising; unusual tiredness or weakness. It has been reported that indomethacin may reduce the antihypertensive effect of captopril, especially in cases of low renin hypertension. Captopril’s effect will be augmented by antihypertensive agents that cause renin release. For example, diuretics (e.g., thiazides) may activate the renin-angiotensin-aldosterone system. — NCATS
Clinical trial activity
433 trials · 313 clinical orgs · 113 marketing orgs
Earliest trial started Jul 1, 1986 (NCT00000525)
Timeline
1950s
1960s
- Jan 27, 1961
G D Searle — Marketing Organization
- Jan 27, 1961
Pfizer — NDA Secondary Org
- Dec 2, 1965
GlaxoSmithKline — Marketing Organization
- Dec 2, 1965
GlaxoSmithKline — NDA Secondary Org
1970s
- Jul 2, 1974
Whiteworth Towne Paulsen — Marketing Organization
- Jan 24, 1975
Teva — Marketing Organization
- May 30, 1975
Barr Laboratories — Marketing Organization
- May 26, 1976
Novartis — Marketing Organization
- Sep 21, 1976
Inwood Laboratories — Marketing Organization
- Dec 17, 1976
Fosun — Marketing Organization
- Jan 7, 1977
Watson Pharmaceuticals — Marketing Organization
- Jan 31, 1977
Hikma — Marketing Organization
- Mar 10, 1977
Lannett Company, Inc. — Marketing Organization
- Mar 21, 1977
Chartwell Pharmaceuticals — Marketing Organization
- May 3, 1977
Solvay — Marketing Organization
- Jun 2, 1977
AmerisourceBergen — Marketing Organization
- Aug 19, 1977
Impax Laboratories — Marketing Organization
- Jul 13, 1978
Roxane Laboratories — Marketing Organization
- Oct 11, 1978
Mylan — Marketing Organization
- Jun 15, 1979
Wyeth — Marketing Organization
- Jun 15, 1979
American Home Products — NDA Secondary Org
1980s
- May 7, 1980
Ivax — Marketing Organization
- Nov 5, 1980
DAVA Pharmaceuticals — Marketing Organization
- Nov 5, 1980
Oxford Pharmaceuticals — Marketing Organization
- Apr 16, 1981
Mutual Pharmaceutical — Marketing Organization
- Apr 16, 1981
Sandoz — Marketing Organization
- Aug 20, 1981
Actavis — Marketing Organization
- Dec 7, 1981
Vanguard — Marketing Organization
- Jul 21, 1982
Alta Pharma — Marketing Organization
- Mar 30, 1983
Lederle — Marketing Organization
- Mar 30, 1983
American Cyanamid — Marketing Organization
- May 10, 1984
West-Ward Pharmaceutical — Marketing Organization
- Oct 12, 1984
Apothecon — Marketing Organization
- Oct 12, 1984
Apothecon — NDA Secondary Org
- Oct 22, 1984
Aurobindo Pharma — NDA Secondary Org
- Dec 28, 1984
Superpharm — Marketing Organization
- Dec 31, 1984
Validus Pharmaceuticals — Marketing Organization
- Dec 31, 1984
Validus Pharmaceuticals — NDA Secondary Org
- Jul 3, 1985
American Home Products — Marketing Organization
- Oct 21, 1985
Par Pharmaceuticals — Marketing Organization
- Oct 21, 1985
Strides Pharma Science — Marketing Organization
- Nov 6, 1985
Puracap Pharmaceutical — Marketing Organization
- Jan 1, 1986
Earliest Phase 3 Sponsor(trial)
- Jan 23, 1986
Rising Pharmaceuticals — Marketing Organization
- Oct 1, 1986
Ani Pharmaceuticals — Marketing Organization
- Oct 1, 1986
Ani Pharmaceuticals — NDA Secondary Org
- Oct 31, 1986
Bausch Health Companies — Marketing Organization
- Oct 31, 1986
Bausch Health Companies — NDA Secondary Org
- Mar 2, 1987
Duramed Research — Marketing Organization
- Apr 6, 1987
Schering — Marketing Organization
- Apr 6, 1987
Schering-Plough — NDA Secondary Org
- Jan 26, 1988
Warner Chilcott — Marketing Organization
- Jul 20, 1989
Alvogen — Marketing Organization
- Jul 20, 1989
Alvogen — NDA Secondary Org
1990s
- Jul 31, 1991
CASI Pharmaceuticals, Inc. — Marketing Organization
- Mar 26, 1993
Teva — NDA Secondary Org
- Nov 30, 1994
Bristol-Myers Squibb — Marketing Organization
- Nov 30, 1994
Bristol-Myers Squibb — NDA Secondary Org
- Apr 28, 1995
Organon — NDA Secondary Org
- Apr 28, 1995
Merck — Marketing Organization
- Apr 26, 1996
Pliva — Marketing Organization
- Dec 27, 1996
Allergan — Marketing Organization
- Dec 27, 1996
Allergan — NDA Secondary Org
- Jun 27, 1997
UCB — Marketing Organization
- Jun 27, 1997
UCB — NDA Secondary Org
- Sep 30, 1997
Sanofi-Aventis — Marketing Organization
- Sep 30, 1997
Sanofi-Aventis — NDA Secondary Org
- Dec 29, 1997
Vintage — Marketing Organization
- Dec 29, 1997
Cosette — Marketing Organization
- Dec 29, 1997
G & W Laboratories Inc. — Marketing Organization
- Dec 29, 1997
ACP Nimble — Marketing Organization
- Jan 1, 1998
Boehringer Ingelheim — Earliest Phase 1 Sponsor(trial)
2000s
- Sep 25, 2000
Epic Pharma Llc — Marketing Organization
- Nov 17, 2000
Boehringer Ingelheim — Marketing Organization
- Nov 17, 2000
Boehringer Ingelheim — NDA Secondary Org
- Sep 18, 2001
Taro Pharmaceuticals — Marketing Organization
- Sep 19, 2001
Upsher-Smith Laboratories — Marketing Organization
- Oct 15, 2001
Dr. Reddy's Laboratories — Marketing Organization
- Mar 29, 2002
Prinston Inc — Marketing Organization
- Jul 1, 2002
Heritage Pharma — Marketing Organization
- Jan 1, 2003
Earliest Phase 2 Sponsor(trial)
- Jun 5, 2003
Daiichi Sankyo — Marketing Organization
- Jun 5, 2003
Cosette — NDA Secondary Org
- Mar 31, 2004
Lupin — Marketing Organization
- Oct 5, 2004
Corepharma — Marketing Organization
- Oct 27, 2004
Nostrum Laboratories — Marketing Organization
- Mar 14, 2006
Aurobindo Pharma — Marketing Organization
- Aug 28, 2006
Advanz Pharma — Marketing Organization
- Aug 28, 2006
Advanz Pharma — NDA Secondary Org
- Mar 16, 2007
Leading Pharma Llc — Marketing Organization
- Jul 20, 2007
IPCA Laboratories Ltd. — Marketing Organization
- Sep 4, 2007
Jubilant Innovation Ltd. — Marketing Organization
- Oct 3, 2007
Apotex — Marketing Organization
- Jan 18, 2008
Noden Pharmaceuticals — Marketing Organization
- Jan 18, 2008
Noden Pharmaceuticals — NDA Secondary Org
- Aug 15, 2008
Unichem — Marketing Organization
- Jul 9, 2009
Invagen Pharms — Marketing Organization
2010s
- Mar 17, 2010
Glenmark Pharmaceuticals — Marketing Organization
- Sep 17, 2010
Emcure — Marketing Organization
- Sep 17, 2010
Avet Lifesciences — Marketing Organization
- Nov 30, 2010
Alembic — Marketing Organization
- Jan 19, 2012
Sun Pharmaceuticals — Marketing Organization
- Aug 9, 2012
Macleods Pharmaceuticals, Ltd — Marketing Organization
- Sep 18, 2012
Cadista — Marketing Organization
- Sep 24, 2012
Accord Research — Marketing Organization
- Sep 28, 2012
Cipla — Marketing Organization
- Apr 19, 2013
Neogen — Marketing Organization
- Feb 25, 2014
Torrent Pharmaceuticals Limited — Marketing Organization
- Jul 23, 2014
Sciegen Pharmaceticals — Marketing Organization
- Jan 15, 2016
Atlas Chemical Industries — Marketing Organization
- Jan 15, 2016
AkzoNobel — Marketing Organization
- Oct 14, 2016
Zhejiang Hisun Pharmaceutical Co. Ltd. — Marketing Organization
- Aug 15, 2017
Zydus Discovery DMCC — Marketing Organization
- Sep 6, 2017
Huaren Pharmaceutical Co Ltd — Marketing Organization
- Feb 11, 2019
Cadila Healthcare — Marketing Organization
- Sep 17, 2019
Umedica Labs Pvt Ltd — Marketing Organization
2020s
- Jul 9, 2020
Edenbridge Pharms — Marketing Organization
- Nov 4, 2021
Novitium Pharma — Marketing Organization
- Feb 23, 2022
Rubicon Research — Marketing Organization
- Aug 11, 2023
Amneal Pharmaceuticals — Marketing Organization
- Sep 29, 2023
Granules India — Marketing Organization
Indications
Approved for
Studied for
- Acute Kidney Injury · Phase 3
- Aging · Phase 2
- Albuminuria · Phase 4
- Angina Pectoris · Phase 4
- Arthritis, Rheumatoid · Phase 1
- Asthma · Phase 1
- Atherosclerosis · Phase 3
- Atrial Fibrillation · Phase 4
- Biological Availability · Phase 1
- Blood Pressure · Phase 4
- Cerebral Small Vessel Diseases · Phase 4
- Chronic Pain · Early Phase 1
- Cognitive Dysfunction · Phase 2
- Coronary Artery Disease · Phase 4
- Critical Illness · Phase 2
- Death, Sudden, Cardiac · Phase 3
- Dent Disease · Phase 2/Phase 3
- Diabetes Mellitus · Phase 4
- Diabetes Mellitus, Type 2 · Phase 4
- Diabetic Nephropathies · Phase 4
- Diabetic Retinopathy · Phase 3
- Diarrhea · Phase 1
- Diuresis · Phase 4
- Drug Interactions · Phase 1
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Edema · Phase 4
- Erectile Dysfunction · Phase 4
- Essential Hypertension · Phase 4
- Fasting · Phase 1
- Fractures, Bone · Phase 3
- Glucose Metabolism Disorders · Phase 4
- Healthy Volunteers · Phase 4
- Heart Arrest · Phase 3
- Heart Disease Risk Factors · Phase 4
- Heart Diseases · Phase 3
- Heart Failure · Phase 4
- Hemodialysis, Home · Phase 4
- Hepatitis B, Chronic · Phase 1
- Hyperhomocysteinemia · Phase 4
- Hyperlipidemias · Phase 2
- Hypernatremia · Phase 2
- Hyperoxaluria · Phase 4
- Hypertension, Pregnancy-Induced · Phase 3
- Hypertrophy, Left Ventricular · Phase 4
- Hyperuricemia · Phase 4
- Hypokalemia · Phase 4
- Hypoparathyroidism · Phase 2
- Insulin Resistance · Phase 1
- Intermittent Claudication · Phase 1
- Kidney Calculi · Phase 2
- Kidney Diseases · Phase 4
- Kidney Failure, Chronic · Phase 4
- Leukemia · Phase 1
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 1
- Menopause · Phase 4
- Metabolic Diseases · Phase 3
- Metabolic Syndrome · Phase 4
- Myocardial Infarction · Phase 4
- Neoplasms · Phase 3
- Nephrolithiasis · Phase 3
- Nephrotic Syndrome · Phase 4
- Neuritis · Phase 2
- Obesity · Phase 4
- Obesity, Abdominal · Phase 4
- Pharmacogenetics · Phase 4
- Pharmacokinetics · Phase 1
- Pharmacology · Phase 1
- Photosensitivity Disorders · Phase 1
- Polycystic Kidney, Autosomal Dominant · Phase 3
- Polycystic Kidney Diseases · Phase 3
- Prediabetic State · Phase 2
- Pre-Eclampsia · Phase 3
- Prehypertension · Phase 4
- Proteinuria · Phase 4
- Renal Insufficiency · Phase 4
- Renal Insufficiency, Chronic · Phase 4
- Sedentary Behavior · Phase 2
- Sleep Apnea, Obstructive · Phase 4
- Spinal Cord Stimulation · Early Phase 1
- Stroke · Phase 4
- Therapeutic Equivalency · Phase 1
- Urolithiasis · Phase 4
- Vascular Stiffness · Early Phase 1
- Ventricular Remodeling · Phase 4
Mechanism of action
SLC12A3 inhibitor
Combination products
accuretic
with quinapril
aldactazide
with spironolactone
Also known as spironolactone/hydrochlorothiazide (25 mg/25 mg) film coated tablets from neolpharma.
aldoril
with methyldopa
amturnide
with amlodipine, aliskiren
apresazide
with hydralazine
Also known as hydralazine and hydrochlorothiazide, hydra-zide
atacand hct
with candesartan
avalide
with irbesartan
Also known as irbesartan hydrochlorothiazide
benicar hct
with olmesartan
capozide
with captopril
diovan hct
with valsartan
dyazide
with triamterene
Also known as maxzide
esimil
with guanethidine
exforge hct
with amlodipine, valsartan
hyzaar
with losartan
Also known as n0877
inderide
with propranolol
Also known as inderide la, propranolol hydrochloride & hydrochlorothiazide
lopressor hct
with metoprolol
Also known as dutoprol
lotensin hct
with benazepril
micardis hct
with telmisartan
moduretic
with amiloride
Also known as hydro-ride
monopril-hct
with fosinopril
normozide
with labetalol
oreticyl forte
with deserpidine
Also known as oreticyl
prinzide
with lisinopril
Also known as zestoretic
ser-ap-es
with hydralazine, reserpine
Also known as cam-ap-es, hydralazine, hydrochlorothiazide w/ reserpine, hydrap-es
serpasil-esidrix
with reserpine
Also known as h.r, hydropres, hydro-reserp, reserpine and hydrochlorothiazide
tekturna hct
with aliskiren
teveten hct
with eprosartan
timolide
with timolol
tribenzor
with amlodipine, olmesartan
Also known as olmesartan medoxomil, amlodipine and hydrochlorothiazide
uniretic
with moexipril
vaseretic
with enalapril
viskazide
with pindolol
ziac
with bisoprolol
Approval history
- approvedFeb 12, 1959
Chemistry & pharmacology
SMILES
NS(=O)(=O)C1=C(Cl)C=C2NCNS(=O)(=O)C2=C1- Mol. weight
- 297.739 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- Yes
- Chirality
- Racemic Mixture
- Inorganic
- No
- Polymer
- No
- Availability
- Prescription Only
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaThiazide ↗
- NCATS0J48LPH2TH ↗
- ChEMBLCHEMBL1562084 ↗
- ChEMBLCHEMBL43686 ↗
- WikipediaHydrochlorothiazide ↗
- ChEMBLCHEMBL15605 ↗
- ChEMBLCHEMBL435 ↗
Also known as
- aliskiren / amlodipine / hydrochlorothiazide
- aliskiren / hydrochlorothiazide
- amiloride mixture with hydrochlorothiazide
- amlodipine besylate / valsartan / hydrochlorothiazide
- amlodipine / valsartan / hydrochlorothiazide
- apo-hydro
- apo-hydro
- behyd
- benclortriazide
- benzclortriazide
- benzylhydrochlorothiazide
- benzylhydrochlorothiazide
- benzylhydrochlorothiazide
- benzylhydrochlorothiazide
- benzylhydrochlorothiazide
- bisoprolol fumarate and hydrochlorothiazide
- esidrex
- esidrex
- esidrix
- esidrix
- esidrix
- hctz
- hctz
- hctz
- hgp0918
- hydochlorothiazide
- hydochlorthiazide
- hydrochlorothiazid
- hydrochlorothiazide
- hydrochlorothiazide
- hydrochlorothiazide
- hydrochlorothiazide
- hydrochlorothiazide
- hydrochlorothiazide
- hydrochlorothiazide
- hydrochlorothiazide
- hydrochlorothiazide
- hydrochlorothiazide
- hydrochlorothiazide
- hydrochlorothiazide intensol
- hydrochlorothiazide intensol
- hydrochlorthiazide
- hydrochlorthiazide
- hydrochlorthiazide
- hydrochlorthiazide
- hydrochlorzide
- hydrocholorothiazide
- hydro-d
- hydro-d
- hydrodiuril
- hydrodiuril
- hydrosaluric
- hydrosaluric
- irbesartan / hydrochlorothiazide
- microzide
- microzide
- mk8266
- mk-8266
- moduretic
- moduretic
- oretic
- oretic
- telmisartan / hydrochlorothiazide
- telmisartan-hydrochlorothiazide
- thiazide
- thiazide
- zide
- zide
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07120607 | Phase 1 | Aug 18, 2025 | Anhui Medical University |
| NCT06491940 | N/A | Aug 1, 2024 | RESnTEC, Institute of Research |
| NCT06362668 | N/A | May 17, 2024 | Reprieve Cardiovascular, Inc |
| NCT06111885 | Phase 2 | Apr 30, 2024 | University of Bern |
| NCT06205407 | Phase 1 | Dec 26, 2023 | Pfizer |
| NCT06167265 | Phase 1 | Nov 28, 2023 | Cliantha Research Limited, Genovate Biotechnology Co., Ltd., |
| NCT05917275 | Phase 4 | Oct 31, 2023 | Radboud University |
| NCT06041529 | Phase 4 | Sep 14, 2023 | Catholic University of Korea, Yuhan Pharmaceutical Company |
| NCT05920005 | Phase 3 | Aug 22, 2023 | Albert Einstein Israelite Hospital, Libbs Farmacêutica LTDA |
| NCT05897372 | Phase 2 | Jun 1, 2023 | University of Copenhagen |
| NCT05373264 | Phase 3 | Feb 28, 2023 | University of Groningen |
| NCT05685277 | Phase 1 | Dec 28, 2022 | Ligand Research, LLC, Pharmtechnology LLC |
| NCT05443932 | Phase 4 | Oct 3, 2022 | Medical University of Vienna |
| NCT05552300 | N/A | Oct 1, 2022 | Sichuan University |
| NCT05526703 | Phase 3 | Sep 28, 2022 | Chong Kun Dang Pharmaceutical |
| NCT05466734 | Phase 1 | Jul 30, 2022 | Bio-Kinetic Clinical Applications, Genovate Biotechnology Co., Ltd., |
| NCT04934228 | Phase 1 | Jul 1, 2022 | University of Kansas |
| NCT05191862 | Phase 1 | Apr 23, 2022 | Genovate Biotechnology Co., Ltd., |
| NCT04964050 | Phase 1 | Dec 24, 2021 | GlaxoSmithKline |
| NCT04927299 | Phase 3 | Jun 30, 2021 | CICMEX Centro de Investigación Clínica de México, Hospital Hispano S.A. de C.V., Instituto de Investigacion de las Alteraciones del Crecimiento, Desarrollo y Enfermedades Metabolicas, Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (BIOMED-GDL), Laboratorios Silanes S.A. de C.V. |
Organizations
Research & Development (313)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Novartis | For profit | 66 | 61 | 4 | 2003 |
| Boehringer Ingelheim | For profit | 38 | 37 | 4 | 1998 |
| Merck | For profit | 31 | 28 | 5 | 1991 |
| Daiichi Sankyo | For profit | 21 | 19 | 3 | 2002 |
| Pfizer | For profit | 18 | 16 | 4 | 2002 |
| Sanofi | For profit | 12 | 9 | 4 | 2003 |
| PRACS | For profit | 11 | 0 | 1 | 2002 |
| Mylan | For profit | 10 | 9 | 2 | 2002 |
| AstraZeneca | For profit | 7 | 6 | 4 | 2003 |
| Ranbaxy | For profit | 7 | 7 | 1 | 2003 |
| Boryung Pharmaceutical Company | For profit | 6 | 6 | 3 | 2009 |
| GlaxoSmithKline | For profit | 6 | 5 | 3 | 2002 |
| Takeda | For profit | 6 | 6 | 2 | 2006 |
| Bristol-Myers Squibb | For profit | 5 | 3 | 3 | 2004 |
| EMS S/A | For profit | 5 | 5 | 1 | 2016 |
| Forest Laboratories | For profit | 5 | 4 | 2 | 2007 |
| IlDong Pharmaceutical Co Ltd | For profit | 5 | 5 | 2 | 2013 |
| Sankyo | For profit | 5 | 4 | 2 | 2001 |
| Seoul National University | Academic/Hospital | 5 | 1 | 4 | 2008 |
| Yonsei University | Academic/Hospital | 5 | 2 | 3 | 2008 |
Marketing (173)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ACP Nimble | For profit | MKTG | Dec 29, 1997 |
| AbbVie | For profit | NDA2 | Jul 6, 1959 |
| Accord Research | For profit | MKTG | Sep 24, 2012 |
| Actavis | For profit | MKTG | Aug 20, 1981 |
| Actavis | For profit | SYN | Feb 11, 2004 |
| Advanz Pharma | For profit | MKTG | Aug 28, 2006 |
| Advanz Pharma | For profit | NDA2 | Aug 28, 2006 |
| AkzoNobel | For profit | MKTG | Jan 15, 2016 |
| Alembic | For profit | MKTG | Nov 30, 2010 |
| Alembic | For profit | SYN | Oct 15, 2012 |
| Allergan | For profit | MKTG | Dec 27, 1996 |
| Allergan | For profit | NDA2 | Dec 27, 1996 |
| Alta Pharma | For profit | MKTG | Jul 21, 1982 |
| Alvogen | For profit | MKTG | Jul 20, 1989 |
| Alvogen | For profit | NDA2 | Jul 20, 1989 |
| Alvogen | For profit | SYN | Jul 20, 1989 |
| Am Therap | For profit | MKTG | — |
| American Cyanamid | For profit | MKTG | Mar 30, 1983 |
| American Home Products | For profit | MKTG | Jul 3, 1985 |
| American Home Products | For profit | NDA2 | Jun 15, 1979 |
| AmerisourceBergen | For profit | MKTG | Jun 2, 1977 |
| Amneal Pharmaceuticals | For profit | MKTG | Aug 11, 2023 |
| Ani Pharmaceuticals | For profit | MKTG | Oct 1, 1986 |
| Ani Pharmaceuticals | For profit | NDA2 | Oct 1, 1986 |
| Apotex | For profit | MKTG | Oct 3, 2007 |
| Apotex | For profit | SYN | Mar 12, 2013 |
| Apotex | For profit | SYN | Dec 8, 1987 |
| Apothecon | For profit | MKTG | Oct 12, 1984 |
| Apothecon | For profit | NDA2 | Oct 12, 1984 |
| Ascot Pharmaceuticals | For profit | MKTG | — |
| Atlas Chemical Industries | For profit | MKTG | Jan 15, 2016 |
| Aurobindo Pharma | For profit | MKTG | Mar 14, 2006 |
| Aurobindo Pharma | For profit | SYN | Jul 20, 2007 |
| Aurobindo Pharma | For profit | SYN | Feb 22, 2013 |
| Aurobindo Pharma | For profit | SYN | Mar 12, 1979 |
| Aurobindo Pharma | For profit | MKTG | Feb 11, 2004 |
| Aurobindo Pharma | For profit | NDA2 | Oct 22, 1984 |
| Avet Lifesciences | For profit | MKTG | Sep 17, 2010 |
| Barr Laboratories | For profit | MKTG | May 30, 1975 |
| Bausch Health Companies | For profit | SYN | Oct 31, 1986 |
| Bausch Health Companies | For profit | MKTG | Oct 31, 1986 |
| Bausch Health Companies | For profit | NDA2 | Oct 31, 1986 |
| Boehringer Ingelheim | For profit | MKTG | Nov 17, 2000 |
| Boehringer Ingelheim | For profit | NDA2 | Nov 17, 2000 |
| Bristol-Myers Squibb | For profit | MKTG | Nov 30, 1994 |
| Bristol-Myers Squibb | For profit | NDA2 | Nov 30, 1994 |
| CASI Pharmaceuticals, Inc. | For profit | MKTG | Jul 31, 1991 |
| Cadila Healthcare | For profit | MKTG | Feb 11, 2019 |
| Cadista | For profit | MKTG | Sep 18, 2012 |
| Chartwell Pharmaceuticals | For profit | MKTG | Mar 21, 1977 |
| Chartwell Pharmaceuticals | For profit | SYN | Jan 27, 2012 |
| Ciba | For profit | NDA | Feb 12, 1959 |
| Cipla | For profit | MKTG | Sep 28, 2012 |
| Corepharma | For profit | MKTG | Oct 5, 2004 |
| Cosette | For profit | MKTG | Dec 29, 1997 |
| Cosette | For profit | NDA2 | Jun 5, 2003 |
| DAVA Pharmaceuticals | For profit | MKTG | Nov 5, 1980 |
| Daiichi Sankyo | For profit | MKTG | Jun 5, 2003 |
| Dr. Reddy's Laboratories | For profit | MKTG | Oct 15, 2001 |
| Duramed Research | For profit | MKTG | Mar 2, 1987 |
| Edenbridge Pharms | For profit | MKTG | Jul 9, 2020 |
| Elkins Sinn | For profit | MKTG | — |
| Emcure | For profit | MKTG | Sep 17, 2010 |
| Epic Pharma Llc | For profit | MKTG | Sep 25, 2000 |
| Fosun | For profit | MKTG | Dec 17, 1976 |
| G & W Laboratories Inc. | For profit | MKTG | Dec 29, 1997 |
| G D Searle | For profit | MKTG | Jan 27, 1961 |
| GlaxoSmithKline | For profit | MKTG | Dec 2, 1965 |
| GlaxoSmithKline | For profit | NDA2 | Dec 2, 1965 |
| Glenmark Pharmaceuticals | For profit | MKTG | Mar 17, 2010 |
| Glenmark Pharmaceuticals | For profit | SYN | Mar 4, 2019 |
| Granules India | For profit | MKTG | Sep 29, 2023 |
| Halsey | For profit | MKTG | — |
| Heather Pharma | For profit | MKTG | — |
| Heritage Pharma | For profit | MKTG | Jul 1, 2002 |
| Heritage Pharma | For profit | SYN | Jan 20, 1978 |
| Heritage Pharma | For profit | SYN | Jan 20, 1978 |
| Hikma | For profit | SYN | Apr 6, 2010 |
| Hikma | For profit | MKTG | Jan 31, 1977 |
| Hikma | For profit | SYN | Apr 6, 2010 |
| Huaren Pharmaceutical Co Ltd | For profit | MKTG | Sep 6, 2017 |
| IPCA Laboratories Ltd. | For profit | MKTG | Jul 20, 2007 |
| Impax Laboratories | For profit | MKTG | Aug 19, 1977 |
| Invagen Pharms | For profit | MKTG | Jul 9, 2009 |
| Inwood Laboratories | For profit | MKTG | Sep 21, 1976 |
| Ivax | For profit | MKTG | May 7, 1980 |
| Jubilant Innovation Ltd. | For profit | MKTG | Sep 4, 2007 |
| Lannett Company, Inc. | For profit | SYN | Jun 24, 1976 |
| Lannett Company, Inc. | For profit | MKTG | Mar 10, 1977 |
| Leading Pharma Llc | For profit | MKTG | Mar 16, 2007 |
| Leading Pharma Llc | For profit | SYN | Mar 16, 2007 |
| Lederle | For profit | MKTG | Mar 30, 1983 |
| Lupin | For profit | MKTG | Mar 31, 2004 |
| Lupin | For profit | SYN | May 21, 2010 |
| MM Pharma | For profit | MKTG | — |
| Macleods Pharmaceuticals, Ltd | For profit | MKTG | Aug 9, 2012 |
| Merck | For profit | NDA2 | Feb 24, 1959 |
| Merck | For profit | MKTG | Apr 28, 1995 |
| Morton Grove Pharmaceuticals | For profit | MKTG | — |
| Mutual Pharmaceutical | For profit | MKTG | Apr 16, 1981 |
| Mylan | For profit | SYN | Aug 3, 1979 |
| Mylan | For profit | SYN | Oct 22, 1984 |
| Mylan | For profit | MKTG | Oct 11, 1978 |
| Neogen | For profit | MKTG | Apr 19, 2013 |
| Noden Pharmaceuticals | For profit | MKTG | Jan 18, 2008 |
| Noden Pharmaceuticals | For profit | NDA2 | Jan 18, 2008 |
| Nostrum Laboratories | For profit | MKTG | Oct 27, 2004 |
| Novartis | For profit | NDA2 | Feb 12, 1959 |
| Novartis | For profit | MKTG | May 26, 1976 |
| Novitium Pharma | For profit | MKTG | Nov 4, 2021 |
| Organon | For profit | NDA2 | Apr 28, 1995 |
| Oxford Pharmaceuticals | For profit | MKTG | Nov 5, 1980 |
| Par Pharmaceuticals | For profit | MKTG | Oct 21, 1985 |
| Par Pharmaceuticals | For profit | SYN | Oct 26, 2016 |
| Parke-Davis | For profit | MKTG | — |
| Pfizer | For profit | SYN | Dec 28, 1999 |
| Pfizer | For profit | NDA2 | Jan 27, 1961 |
| Pliva | For profit | MKTG | Apr 26, 1996 |
| Prinston Inc | For profit | MKTG | Mar 29, 2002 |
| Puracap Pharmaceutical | For profit | MKTG | Nov 6, 1985 |
| Quantum Pharmaceutical | For profit | MKTG | — |
| Rising Pharmaceuticals | For profit | MKTG | Jan 23, 1986 |
| Rising Pharmaceuticals | For profit | MKTG | Oct 31, 1991 |
| Roxane Laboratories | For profit | MKTG | Jul 13, 1978 |
| Rubicon Research | For profit | MKTG | Feb 23, 2022 |
| Sandoz | For profit | MKTG | Apr 16, 1981 |
| Sanofi-Aventis | For profit | MKTG | Sep 30, 1997 |
| Sanofi-Aventis | For profit | NDA2 | Sep 30, 1997 |
| Schering | For profit | MKTG | Apr 6, 1987 |
| Schering-Plough | For profit | NDA2 | Apr 6, 1987 |
| Sciegen Pharmaceticals | For profit | MKTG | Jul 23, 2014 |
| Solvay | For profit | MKTG | May 3, 1977 |
| Strides Pharma Science | For profit | MKTG | Oct 21, 1985 |
| Sun Pharmaceuticals | For profit | MKTG | Jan 19, 2012 |
| Sun Pharmaceuticals | For profit | SYN | Mar 27, 2007 |
| Sun Pharmaceuticals | For profit | SYN | Jul 1, 2002 |
| Sun Pharmaceuticals | For profit | SYN | Oct 3, 1974 |
| Superpharm | For profit | MKTG | Dec 28, 1984 |
| Taro Pharmaceuticals | For profit | MKTG | Sep 18, 2001 |
| Teva | For profit | SYN | Jan 12, 1973 |
| Teva | For profit | SYN | Feb 7, 1985 |
| Teva | For profit | SYN | Mar 26, 1993 |
| Teva | For profit | SYN | Apr 6, 2010 |
| Teva | For profit | SYN | Dec 11, 2012 |
| Teva | For profit | MKTG | Jan 24, 1975 |
| Teva | For profit | NDA2 | Mar 26, 1993 |
| Torrent Pharmaceuticals Limited | For profit | MKTG | Feb 25, 2014 |
| Torrent Pharmaceuticals Limited | For profit | SYN | Apr 6, 2010 |
| Torrent Pharmaceuticals Limited | For profit | SYN | Apr 10, 2012 |
| UCB | For profit | MKTG | Jun 27, 1997 |
| UCB | For profit | NDA2 | Jun 27, 1997 |
| Umedica Labs Pvt Ltd | For profit | MKTG | Sep 17, 2019 |
| Unichem | For profit | SYN | Jul 21, 2017 |
| Unichem | For profit | MKTG | Aug 15, 2008 |
| Upsher-Smith Laboratories | For profit | MKTG | Sep 19, 2001 |
| Upsher-Smith Laboratories | For profit | SYN | Apr 19, 1982 |
| Validus Pharmaceuticals | For profit | MKTG | Dec 31, 1984 |
| Validus Pharmaceuticals | For profit | NDA2 | Dec 31, 1984 |
| Vanguard | For profit | MKTG | Dec 7, 1981 |
| Vintage | For profit | MKTG | Dec 29, 1997 |
| Vitarine | For profit | MKTG | — |
| Warner Chilcott | For profit | MKTG | Jan 26, 1988 |
| Watson Pharmaceuticals | For profit | MKTG | Jan 7, 1977 |
| Watson Pharmaceuticals | For profit | SYN | Sep 15, 2011 |
| Watson Pharmaceuticals | For profit | SYN | Oct 22, 2012 |
| West-Ward Pharmaceutical | For profit | MKTG | May 10, 1984 |
| West-Ward Pharmaceutical | For profit | SYN | Apr 6, 2010 |
| Whiteworth Towne Paulsen | For profit | MKTG | Jul 2, 1974 |
| Wyeth | For profit | MKTG | Jun 15, 1979 |
| Zhejiang Hisun Pharmaceutical Co. Ltd. | For profit | MKTG | Oct 14, 2016 |
| Zydus Discovery DMCC | For profit | MKTG | Aug 15, 2017 |
| Zydus Discovery DMCC | For profit | SYN | Oct 6, 2010 |
| Zydus Discovery DMCC | For profit | SYN | Nov 27, 2017 |