erythromycin
Trade name: ilosone
Approved
Jun 24, 1964
Erythromycin ethylsuccinate (E.E.S.®, ERY-PED®) is an ester of erythromycin base and succinic acid. It is suitable for oral administration. Erythromycin is a macrolide antibiotic, produced by Saccharopolyspora erythraea (formerly Streptomyces erythraeus). It acts primarily as a bacteriostatic agent. In sensitive organisms, it inhibits protein synthesis by binding to 50S ribosomal subunits. This binding process inhibits peptidyl transferase activity and interferes with translocation of amino acids during translation and assembly of proteins. Erythromycin does not affect nucleic acid synthesis. — NCATS
Clinical trial activity
86 trials · 102 clinical orgs · 76 marketing orgs
Earliest trial started Jan 1, 1985 (NCT00000120)
Timeline
1960s
1970s
- Aug 6, 1970
Arbor Pharmaceuticals — NDA Secondary Org
- Sep 8, 1972
Ani Pharmaceuticals — Marketing Organization
- Jan 16, 1973
Mylan — Marketing Organization
- Dec 5, 1974
Bristol-Myers — Marketing Organization
- Jan 3, 1975
Eli Lilly — Marketing Organization
- Aug 24, 1977
Parke-Davis — Marketing Organization
- Aug 24, 1977
Warner Lambert — Marketing Organization
- Jun 14, 1979
Watson Pharmaceuticals — Marketing Organization
- Nov 29, 1979
Abbott — Marketing Organization
- Nov 29, 1979
Abbott — NDA Secondary Org
1980s
- Apr 28, 1980
Barr Laboratories — Marketing Organization
- Jun 3, 1980
Squibb — NDA Secondary Org
- Jan 26, 1981
Mayne Pharma — NDA Secondary Org
- Jan 26, 1981
Dr. Reddy's Laboratories — Marketing Organization
- Jan 26, 1981
Dr. Reddy's Laboratories — NDA Secondary Org
- May 22, 1981
Warner Chilcott — Marketing Organization
- Aug 11, 1981
Alpharma — Marketing Organization
- Nov 18, 1982
Taro Pharmaceuticals — Marketing Organization
- Dec 17, 1982
Life Labs — Marketing Organization
- Mar 9, 1983
Squibb — Marketing Organization
- Sep 26, 1983
Padagis Us — Marketing Organization
- Oct 26, 1984
Bausch Health Companies — Marketing Organization
- Oct 26, 1984
Bausch Health Companies — NDA Secondary Org
- Jan 1, 1985
Earliest Phase 3 Sponsor(trial)
- Jan 10, 1985
Dow Pharmaceutical Sciences — NDA Secondary Org
- Jan 24, 1985
Dow Pharmaceutical Sciences — Marketing Organization
- Feb 15, 1985
Johnson and Johnson — NDA Secondary Org
- Mar 28, 1985
Elkins Sinn — Marketing Organization
- Jul 3, 1985
Fougera — Marketing Organization
- Jul 3, 1985
Syosset — Marketing Organization
- Jul 11, 1985
Merz — Marketing Organization
- Jul 25, 1985
Pharmafair — Marketing Organization
- Oct 31, 1986
Hospira — Marketing Organization
- Oct 21, 1987
Mylan — NDA Secondary Org
- Oct 23, 1987
Xttrium Laboratories — Marketing Organization
- Oct 23, 1987
Wockhardt — Marketing Organization
- Feb 5, 1988
Micro Labs Ltd India — Marketing Organization
- Feb 5, 1988
Saptalis Pharmaceuticals — Marketing Organization
- Jun 15, 1988
Alta Pharma — Marketing Organization
- Sep 14, 1988
Aurobindo Pharma — Marketing Organization
- May 9, 1989
Baxalta — Marketing Organization
- May 9, 1989
Baxter — Marketing Organization
1990s
- Oct 17, 1990
Cosette — Marketing Organization
- Oct 17, 1990
ACP Nimble — Marketing Organization
- Oct 17, 1990
G & W Laboratories Inc. — Marketing Organization
- Aug 23, 1991
Altana — Marketing Organization
- Jan 29, 1993
Perrigo — Marketing Organization
- Jul 30, 1993
Teva — Marketing Organization
- Jan 27, 1994
Bausch & Lomb — Marketing Organization
- Jul 18, 1996
Akorn, Inc. — Marketing Organization
- Jul 18, 1996
SENTISS — Marketing Organization
- Oct 22, 1996
Hi Tech Pharmaceuticals — Marketing Organization
- Feb 14, 1997
Renaissance Pharma — Marketing Organization
- Jan 1, 1999
Earliest Phase 1 Sponsor(trial)
- Jan 1, 1999
Earliest Phase 2 Sponsor(trial)
2000s
- Nov 27, 2000
Cutanea Life Sciences, Inc. — Marketing Organization
- Nov 27, 2000
Biofrontera Bioscience GmbH — NDA Secondary Org
- Mar 29, 2004
Encube Ethicals Pvt. Ltd. — Marketing Organization
- Mar 29, 2004
Tolmar Inc. — Marketing Organization
2010s
- Sep 18, 2015
Lyne Laboratories — Marketing Organization
- Jul 19, 2017
Pharmaceutical Associates — Marketing Organization
- Jul 19, 2017
Teligent Pharmaceuticals — Marketing Organization
- Mar 9, 2018
Amneal Pharmaceuticals — Marketing Organization
- Oct 23, 2019
Par Pharmaceuticals — Marketing Organization
- Oct 23, 2019
Bristol-Myers Squibb — Marketing Organization
2020s
- Jul 6, 2020
Torrent Pharmaceuticals Limited — Marketing Organization
- Sep 17, 2020
Exela Pharma Sciences, LLC. — Marketing Organization
- Jun 28, 2021
Cadila Healthcare — Marketing Organization
- Feb 14, 2022
Nexus Pharmaceuticals — Marketing Organization
- Jul 13, 2022
Alkem Labs Ltd — Marketing Organization
- Mar 7, 2023
Zydus Discovery DMCC — Marketing Organization
- Aug 24, 2023
Alembic — Marketing Organization
Indications
Approved for
Studied for
- Acne Vulgaris · Phase 4
- Albinism, Oculocutaneous · Phase 1/Phase 2
- Allergy and Immunology · Phase 4
- Amyotrophic Lateral Sclerosis · Phase 1
- Asthma · Phase 4
- Bacterial Infections · Phase 4
- Blepharitis · Phase 4
- Breast Neoplasms · Phase 2
- Bronchiolitis · Phase 4
- Bronchiolitis Obliterans · Phase 4
- Bulimia Nervosa · Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 3
- Chlamydia · Phase 2
- Chlamydia Infections · Phase 3
- Colorectal Neoplasms · Phase 2
- COVID-19 · Phase 4
- Diabetes Mellitus, Type 1 · Phase 1
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Epidermolysis Bullosa · Phase 3
- Erectile Dysfunction · Phase 1
- Eyelid Diseases · Phase 4
- Feeding and Eating Disorders · Phase 2
- Gastrectomy · Phase 2
- Gastric Emptying · Phase 2
- Gastrointestinal Hemorrhage · Phase 3
- Gastroparesis · Phase 2
- General Surgery · Phase 4
- Healthy Volunteers · Phase 4
- Heart Diseases · Phase 1
- Hematemesis · Phase 3
- Hepacivirus · Phase 1
- Hermanski-Pudlak Syndrome · Phase 1/Phase 2
- HIV Infections · Phase 3
- Infant, Premature · Phase 4
- Infertility · Phase 3
- Intestinal Neoplasms · Phase 3
- Intestinal Polyposis · Phase 4
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 1
- Metabolic Diseases · Phase 1/Phase 2
- Nausea · Phase 4
- Obesity · Phase 4
- Ophthalmia Neonatorum · Phase 3
- Pancreatitis · Phase 4
- Pharmacokinetics · Phase 1
- Platelet Storage Pool Deficiency · Phase 1/Phase 2
- Pneumonia · Phase 3
- Pregnancy, High-Risk · Phase 4
- Premature Birth · Phase 4
- Psoriasis · Phase 3
- Pulmonary Disease, Chronic Obstructive · Phase 2/Phase 3
- Pulmonary Fibrosis · Phase 1/Phase 2
- Renal Insufficiency · Phase 1
- Respiratory Aspiration of Gastric Contents · Phase 2
- Safety · Phase 2
- Skin Neoplasms · Phase 4
- Stomach Diseases · Early Phase 1
- Stomach Neoplasms · Phase 2
- Surgical Wound · Phase 4
- Surgical Wound Infection · Phase 4
- Uterine Cervicitis · Early Phase 1
- Wound Infection · Phase 4
- Wounds and Injuries · Phase 4
Mechanism of action
- Bacterial 70S ribosomeINHIBITOR
Bacterial 70S ribosome inhibitor
23S RRNA
- 30S ribosomal protein S2 (rpsB) ↗
- 50S ribosomal protein L4 (rplD) ↗
- 30S ribosomal protein S15 (rpsO) ↗
- 30S ribosomal protein S16 (rpsP) ↗
- 30S ribosomal protein S17 (rpsQ) ↗
- 30S ribosomal protein S18 (rpsR) ↗
- 30S ribosomal protein S19 (rpsS) ↗
- 30S ribosomal protein S20 (rpsT) ↗
- 30S ribosomal protein S21 (rpsU) ↗
- 30S ribosomal protein S3 (rpsC) ↗
- 30S ribosomal protein S4 (rpsD) ↗
- 30S ribosomal protein S5 (rpsE) ↗
- 30S ribosomal protein S6 (rpsF) ↗
- 30S ribosomal protein S7 (rpsG) ↗
- 30S ribosomal protein S8 (rpsH) ↗
- 30S ribosomal protein S9 (rpsI) ↗
- 50S ribosomal protein L35 (rpmI) ↗
- 50S ribosomal protein L36 2 (ykgO) ↗
- 50S ribosomal protein L36 (rpmJ) ↗
- 50S ribosomal protein L3 (rplC) ↗
- 50S ribosomal protein L5 (rplE) ↗
- 50S ribosomal protein L6 (rplF) ↗
- 50S ribosomal protein L7/L12 (rplL) ↗
- 30S ribosomal protein S1 (rpsA) ↗
- 30S ribosomal protein S10 (rpsJ) ↗
- 30S ribosomal protein S11 (rpsK) ↗
- 30S ribosomal protein S12 (rpsL) ↗
- 30S ribosomal protein S13 (rpsM) ↗
- 30S ribosomal protein S14 (rpsN) ↗
- 50S ribosomal protein L10 (rplJ) ↗
- 50S ribosomal protein L11 (rplK) ↗
- 50S ribosomal protein L13 (rplM) ↗
- 50S ribosomal protein L14 (rplN) ↗
- 50S ribosomal protein L15 (rplO) ↗
- 50S ribosomal protein L16 (rplP) ↗
- 50S ribosomal protein L17 (rplQ) ↗
- 50S ribosomal protein L18 (rplR) ↗
- 50S ribosomal protein L19 (rplS) ↗
- 50S ribosomal protein L1 (rplA) ↗
- 50S ribosomal protein L20 (rplT) ↗
- 50S ribosomal protein L21 (rplU) ↗
- 50S ribosomal protein L22 (rplV) ↗
- 50S ribosomal protein L23 (rplW) ↗
- 50S ribosomal protein L24 (rplX) ↗
- 50S ribosomal protein L25 (rplY) ↗
- 50S ribosomal protein L27 (rpmA) ↗
- 50S ribosomal protein L28 (rpmB) ↗
- 50S ribosomal protein L29 (rpmC) ↗
- 50S ribosomal protein L2 (rplB) ↗
- 50S ribosomal protein L30 (rpmD) ↗
- 50S ribosomal protein L31 type B (ykgM) ↗
- 50S ribosomal protein L31 (rpmE) ↗
- 50S ribosomal protein L32 (rpmF) ↗
- 50S ribosomal protein L33 (rpmG) ↗
- 50S ribosomal protein L34 (rpmH) ↗
Combination products
benzamycin
with benzoyl peroxide
Also known as aktipak
pediazole
with sulfisoxazole
Also known as eryzole
Approval history
- approvedJun 24, 1964
Chemistry & pharmacology
SMILES
CC[C@H]1OC(=O)[C@H](C)[C@@H](O[C@H]2C[C@@](C)(OC)[C@@H](O)[C@H](C)O2)[C@H](C)[C@@H](O[C@@H]3O[C@H](C)C[C@@H]([C@H]3O)N(C)C)[C@](C)(O)C[C@@H](C)C(=O)[C@H](C)[C@@H](O)[C@]1(C)O- Mol. weight
- 733.9268 g/mol
- Lipinski Ro5
- 2 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaErythromycin ↗
- NCATS63937KV33D ↗
- ChEMBLCHEMBL2220427 ↗
- ChEMBLCHEMBL2218877 ↗
- ChEMBLCHEMBL532 ↗
- ChEMBLCHEMBL1200510 ↗
- ChEMBLCHEMBL1200506 ↗
- ChEMBLCHEMBL1200688 ↗
- ChEMBLCHEMBL3545060 ↗
Also known as
- 3''-o-demethylerythromycin
- 3''-o-demethylerythromycin
- abomacetin
- abomacetin
- aknemycin
- akne-mycin
- akne-mycin
- akne-mycin
- aknemycin plus
- anamycin
- a/t/s
- a/t/s
- bristamycin
- bristamycin
- c-solve-2
- c-solve-2
- davercin
- davercin
- e-base
- e-base
- e.e.s.
- e.e.s.
- e.e.s. 200
- e.e.s. 200
- e.e.s. 400
- e.e.s. 400
- e-glades
- e-glades
- emgel
- emgel
- e-mycin
- e-mycin
- e-mycin e
- e-mycin e
- eritrocina
- eritrocina
- eritromicina
- eritromicina
- eryacne 2
- eryacne 4
- eryc
- eryc
- eryc 125
- eryc 125
- erycette
- erycette
- eryc sprinkles
- eryc sprinkles
- eryderm
- eryderm
- erygel
- erygel
- erymax
- erymax
- erymax sprinkle
- erymin
- erypar
- erypar
- eryped
- eryped
- ery-tab
- ery-tab
- erythomycin
- erythomycin
- erythra-derm
- erythra-derm
- erythro 200
- erythrocin
- erythrocin
- erythrocin
- erythrocin 500
- erythrocin acne pack
- erythrocin ethyl succinate
- erythrocin stearate
- erythrocin stearate
- erythroden
- erythromycin
- erythromycin
- erythromycin
- erythromycin
- erythromycin
- erythromycin
- erythromycin
- erythromycin
- erythromycin
- erythromycin
- erythromycin
- erythromycin a
- erythromycin a
- erythromycin a
- erythromycin a 11,12-carbonate
- erythromycin a carbonate
- erythromycin a carbonate
- erythromycin a cyclic 11,12-carbonate
- erythromycin-ammonium bituminosulfonate
- erythromycin, ammonium bituminosulfonate drug combination
- erythromycin c
- erythromycin c
- erythromycin cyclic carbonate
- érythromycine
- érythromycine
- erythromycin estolate
- erythromycin estolate
- erythromycin estolate
- erythromycin estolate
- erythromycin ethylsuccinate
- erythromycin ethylsuccinate
- erythromycin ethylsuccinate
- erythromycin ethylsuccinate
- erythromycin ethylsuccinate
- erythromycin ethylsuccinate
- erythromycin ethyl succinate
- erythromycin ethyl succinate
- erythromycin ethyl succinate
- erythromycin ethyl succinate
- erythromycin gluceptate
- erythromycin gluceptate
- erythromycin gluceptate
- erythromycin gluceptate
- erythromycin glucoheptonate
- erythromycin glucoheptonate
- erythromycin glucoheptonate
- erythromycin-ichthammol
- erythromycin lactobionate
- erythromycin lactobionate
- erythromycin lactobionate
- erythromycin lactobionate
- erythromycin lauryl sulfate, propionyl
- erythromycin lauryl sulfate, propionyl
- erythromycin propionate
- erythromycin propionate
- erythromycin propionate
- erythromycin propionate
- erythromycin propionate
- erythromycin propionate
- erythromycin propionate lauryl sulfate
- erythromycin propionate lauryl sulfate
- erythromycin stearate
- erythromycin stearate
- erythromycin stearate
- erythromycin stearate
- erythromycinum
- erythromycinum
- erythromycin - zinc acetate
- erythromycin, zinc acetate drug combination
- erythroped
- erythroped
- erythroped a
- erythroped fte
- erythroped fte sf
- erythroped pi
- erythroped pi sf
- erythroped sf
- erythro-statin
- erythro-statin
- erytromycin
- erytromycin
- e-solve 2
- e-solve 2
- ethril 250
- ethril 250
- ethril 500
- ethril 500
- gallimycin
- gallimycin
- gallimycin
- ilosone
- ilosone
- ilosone
- ilotycin
- ilotycin
- ilotycin gluceptate
- ilotycin gluceptate
- isotrexin
- kerymax
- nyc 0462
- oftalmolosa cusi eritromicina
- oftalmolosa cusi eritromicina
- paediathrocin
- paediathrocin
- pce
- pce
- pediamycin
- pediamycin
- pediamycin 400
- pediamycin 400
- pfizer-e
- pfizer-e
- primacine
- primacine
- propiocine
- propionyl eryhthromycin
- propionyl erythromicin
- propionylerythromycin
- propionyl erythromycin lauryl sulfate
- propionyl erythromycin lauryl sulfate
- retcin
- retcin
- robimycin
- robimycin
- rommix 125
- rommix 250 ec
- rommix 500 ec
- r-p mycin
- r-p mycin
- sansac
- sansac
- staticin
- staticin
- stiemycin
- stiemycin
- superfact
- tiloryth
- tiloryth
- tiloryth
- t-stat
- t-stat
- wyamycin
- wyamycin
- wyamycin e
- wyamycin e
- wyamycin s
- wyamycin s
- zineryt
- zineryt
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06906757 | N/A | Sep 30, 2025 | University of Melbourne |
| NCT07063082 | N/A | Jul 7, 2025 | Cairo University |
| NCT06948747 | Phase 1 | May 6, 2025 | AstraZeneca |
| NCT06917872 | Phase 1 | Apr 29, 2025 | Boehringer Ingelheim |
| NCT06461429 | N/A | Feb 1, 2025 | La Trobe University, Mater Medical Research Institute, Menzies School of Health Research, Monash University, University of Adelaide, University of Auckland, University of Melbourne, University of New South Wales, University of Sydney, University of Tasmania, University of Western Australia |
| NCT06607887 | Phase 4 | Aug 30, 2024 | Minia University, Sohag University |
| NCT06396078 | Phase 4 | Jul 18, 2024 | Ohio State University |
| NCT06395610 | Phase 1 | Mar 28, 2024 | Chiesi |
| NCT06273891 | Phase 3 | Mar 8, 2024 | Eastern Virginia Medical School, Inova Health System |
| NCT06858618 | Phase 2 | Aug 16, 2023 | Fosun |
| NCT05995249 | Phase 1 | Aug 11, 2023 | Takeda |
| NCT05675293 | Early Phase 1 (Phase 1) | Jan 15, 2023 | October 6 University |
| NCT05797753 | Phase 1 | Feb 18, 2022 | Sanofi |
| NCT04714554 | Phase 1 | Jan 6, 2021 | Myovant Sciences GmbH |
| NCT04682691 | Early Phase 1 (Phase 1) | Jan 1, 2021 | Cairo University |
| NCT04665089 | N/A | Jan 1, 2021 | Tunis University |
| NCT03966066 | N/A | Aug 31, 2019 | Capital Medical University |
| NCT04066231 | N/A | Aug 26, 2019 | Katholieke Universiteit Leuven |
| NCT03779360 | N/A | Oct 12, 2018 | Leiden University, Maruho Co., Ltd. |
| NCT03593252 | N/A | Sep 1, 2018 | McMaster University |
Organizations
Research & Development (102)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Katholieke Universiteit Leuven | Academic/Hospital | 5 | 5 | 2 | 2012 |
| Boehringer Ingelheim | For profit | 3 | 3 | 1 | 1999 |
| Cairo University | Academic/Hospital | 3 | 3 | 2 | 2018 |
| Pfizer | For profit | 3 | 3 | 2 | 2003 |
| Baqiyatallah Medical Sciences University | Academic/Hospital | 2 | 2 | 1 | 2006 |
| Indiana University | Academic/Hospital | 2 | 2 | 2 | 2006 |
| Johnson and Johnson | For profit | 2 | 2 | 1 | 2011 |
| Leiden University | Academic/Hospital | 2 | 2 | 2 | 2018 |
| Maruho Co., Ltd. | For profit | 2 | 0 | 2 | 2018 |
| Mayo Clinic | Academic/Hospital | 2 | 2 | 2 | 2010 |
| National Institute of Mental Health (NIMH) | Government | 2 | 0 | 2 | 2001 |
| Tel Aviv University | Academic/Hospital | 2 | 2 | 1 | 2014 |
| University of Melbourne | Academic/Hospital | 2 | 2 | 1 | 2025 |
| University of Michigan | Academic/Hospital | 2 | 2 | 1 | 1999 |
| AIO-Studien-gGmbH | For profit | 1 | 1 | 1 | 2011 |
| Assiut University | Academic/Hospital | 1 | 1 | 1 | 2017 |
| AstraZeneca | For profit | 1 | 1 | 1 | 2025 |
| Aventis | For profit | 1 | 0 | 1 | 1999 |
| Bausch & Lomb | For profit | 1 | 0 | 1 | 2011 |
| Bayer | For profit | 1 | 0 | 1 | 2011 |
Marketing (100)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ACP Nimble | For profit | MKTG | Oct 17, 1990 |
| AH Robins | For profit | MKTG | — |
| Abbott | For profit | SYN | Jan 4, 1988 |
| Abbott | For profit | MKTG | Nov 29, 1979 |
| Abbott | For profit | NDA2 | Nov 29, 1979 |
| Abraxis | For profit | MKTG | — |
| Akorn, Inc. | For profit | MKTG | Jul 18, 1996 |
| Alembic | For profit | MKTG | Aug 24, 2023 |
| Alkem Labs Ltd | For profit | MKTG | Jul 13, 2022 |
| Alpharma | For profit | MKTG | Aug 11, 1981 |
| Alta Pharma | For profit | MKTG | Jun 15, 1988 |
| Altana | For profit | MKTG | Aug 23, 1991 |
| American Home Products | For profit | MKTG | — |
| Amneal Pharmaceuticals | For profit | SYN | Nov 1, 2019 |
| Amneal Pharmaceuticals | For profit | MKTG | Mar 9, 2018 |
| Ani Pharmaceuticals | For profit | SYN | Sep 8, 1972 |
| Ani Pharmaceuticals | For profit | MKTG | Sep 8, 1972 |
| Arbor Pharmaceuticals | For profit | NDA2 | Aug 6, 1970 |
| Arbor Pharmaceuticals | For profit | SYN | Jun 24, 1964 |
| Arbor Pharmaceuticals | For profit | MKTG | Jun 24, 1964 |
| Athenex, Inc. | For profit | MKTG | — |
| Aurobindo Pharma | For profit | MKTG | Sep 14, 1988 |
| Azurity | For profit | MKTG | Apr 2, 1965 |
| Azurity | For profit | NDA2 | Apr 2, 1965 |
| Barr Laboratories | For profit | MKTG | Apr 28, 1980 |
| Bausch & Lomb | For profit | MKTG | Jan 27, 1994 |
| Bausch Health Companies | For profit | MKTG | Oct 26, 1984 |
| Bausch Health Companies | For profit | SYN | Jan 10, 1985 |
| Bausch Health Companies | For profit | NDA2 | Oct 26, 1984 |
| Baxalta | For profit | MKTG | May 9, 1989 |
| Baxter | For profit | MKTG | May 9, 1989 |
| Biofrontera Bioscience GmbH | For profit | NDA2 | Nov 27, 2000 |
| Bristol-Myers | For profit | MKTG | Dec 5, 1974 |
| Bristol-Myers Squibb | For profit | MKTG | Oct 23, 2019 |
| Cadila Healthcare | For profit | MKTG | Jun 28, 2021 |
| Cosette | For profit | MKTG | Oct 17, 1990 |
| Cutanea Life Sciences, Inc. | For profit | MKTG | Nov 27, 2000 |
| Dow Pharmaceutical Sciences | For profit | NDA2 | Jan 10, 1985 |
| Dow Pharmaceutical Sciences | For profit | MKTG | Jan 24, 1985 |
| Dr. Reddy's Laboratories | For profit | MKTG | Jan 26, 1981 |
| Dr. Reddy's Laboratories | For profit | NDA2 | Jan 26, 1981 |
| Eli Lilly | For profit | NDA | Jun 29, 1964 |
| Eli Lilly | For profit | SYN | Apr 13, 1967 |
| Eli Lilly | For profit | MKTG | Jan 3, 1975 |
| Elkins Sinn | For profit | MKTG | Mar 28, 1985 |
| Encube Ethicals Pvt. Ltd. | For profit | MKTG | Mar 29, 2004 |
| Exela Pharma Sciences, LLC. | For profit | MKTG | Sep 17, 2020 |
| Fougera | For profit | MKTG | Jul 3, 1985 |
| G & W Laboratories Inc. | For profit | MKTG | Oct 17, 1990 |
| Hi Tech Pharmaceuticals | For profit | MKTG | Oct 22, 1996 |
| Hospira | For profit | NDA2 | Jun 25, 1964 |
| Hospira | For profit | MKTG | Oct 31, 1986 |
| Johnson and Johnson | For profit | NDA2 | Feb 15, 1985 |
| Lederle | For profit | MKTG | — |
| Life Labs | For profit | MKTG | Dec 17, 1982 |
| Lyne Laboratories | For profit | MKTG | Sep 18, 2015 |
| Mayne Pharma | For profit | NDA2 | Jan 26, 1981 |
| Merz | For profit | MKTG | Jul 11, 1985 |
| Micro Labs Ltd India | For profit | MKTG | Feb 5, 1988 |
| Mylan | For profit | SYN | Oct 21, 1987 |
| Mylan | For profit | MKTG | Jan 16, 1973 |
| Mylan | For profit | SYN | Feb 5, 1988 |
| Mylan | For profit | NDA2 | Oct 21, 1987 |
| Naska Pharmacal | For profit | MKTG | — |
| Nexus Pharmaceuticals | For profit | MKTG | Feb 14, 2022 |
| Nexus Pharmaceuticals | For profit | SYN | Feb 14, 2022 |
| Padagis Us | For profit | MKTG | Sep 26, 1983 |
| Paddock Laboratories | For profit | NDA2 | — |
| Par Pharmaceuticals | For profit | MKTG | Oct 23, 2019 |
| Parke-Davis | For profit | MKTG | Aug 24, 1977 |
| Perrigo | For profit | MKTG | Jan 29, 1993 |
| Perrigo | For profit | SYN | Sep 26, 1983 |
| Perrigo | For profit | SYN | Jan 11, 1991 |
| Pfizer | For profit | MKTG | — |
| Pharmaceutical Associates | For profit | MKTG | Jul 19, 2017 |
| Pharmacia & Upjohn | For profit | MKTG | — |
| Pharmaderm | For profit | MKTG | — |
| Pharmafair | For profit | MKTG | Jul 25, 1985 |
| Puracap Pharmaceutical | For profit | MKTG | — |
| Renaissance Pharma | For profit | MKTG | Feb 14, 1997 |
| SENTISS | For profit | MKTG | Jul 18, 1996 |
| Saptalis Pharmaceuticals | For profit | MKTG | Feb 5, 1988 |
| Solvay | For profit | MKTG | — |
| Squibb | For profit | NDA2 | Jun 3, 1980 |
| Squibb | For profit | MKTG | Mar 9, 1983 |
| Syosset | For profit | MKTG | Jul 3, 1985 |
| Taro Pharmaceuticals | For profit | MKTG | Nov 18, 1982 |
| Teligent Pharmaceuticals | For profit | SYN | Jul 19, 2017 |
| Teligent Pharmaceuticals | For profit | MKTG | Jul 19, 2017 |
| Teva | For profit | SYN | Feb 11, 2021 |
| Teva | For profit | SYN | Jul 30, 1993 |
| Teva | For profit | MKTG | Jul 30, 1993 |
| Tolmar Inc. | For profit | MKTG | Mar 29, 2004 |
| Torrent Pharmaceuticals Limited | For profit | MKTG | Jul 6, 2020 |
| Warner Chilcott | For profit | MKTG | May 22, 1981 |
| Warner Lambert | For profit | MKTG | Aug 24, 1977 |
| Watson Pharmaceuticals | For profit | MKTG | Jun 14, 1979 |
| Wockhardt | For profit | MKTG | Oct 23, 1987 |
| Xttrium Laboratories | For profit | MKTG | Oct 23, 1987 |
| Zydus Discovery DMCC | For profit | MKTG | Mar 7, 2023 |