clindamycin
Trade name: cleocin
Approved
Feb 22, 1970
Clindamycin phosphate is the prodrug of clindamycin with no antimicrobial activity in vitro but can be rapidly converted in vivo to the parent drug, clindamycin, by phosphatase ester hydrolysis. It is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria: Lower respiratory tract infections including pneumonia, empyema, and lung abscess caused by anaerobes; Skin and skin structure infections; Gynecological infections including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by susceptible anaerobes; Intra-abdominal infections; Septicemia; Bone and joint infections. Orally and parenterally administered clindamycin has been associated with severe colitis, which may end fatally. Abdominal pain, gastrointestinal disturbances, gram-negative folliculitis, eye pain and contact dermatitis have also been reported in association with the use of topical formulations of clindamycin. Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents — NCATS
Clinical trial activity
199 trials · 282 clinical orgs · 73 marketing orgs
Earliest trial started Nov 2, 1999 (NCT00000674)
Timeline
1970s
- Feb 22, 1970
Earliest FDA Approval
- Feb 22, 1970
Pharmacia & Upjohn — NDA Secondary Org
- Feb 22, 1970
Pfizer — Marketing Organization
- Feb 22, 1970
Pfizer — NDA Secondary Org
1980s
- Jul 9, 1980
Pharmacia & Upjohn — First NDA Organization
- Jul 9, 1980
Pharmacia & Upjohn — NDA Organization
- Feb 8, 1982
Pharmacia & Upjohn — Marketing Organization
- Jul 24, 1987
Alvogen — Marketing Organization
- Jul 24, 1987
Almaject — Marketing Organization
- Oct 15, 1987
West-Ward Pharmaceutical — Marketing Organization
- Oct 15, 1987
Hikma — Marketing Organization
- May 9, 1988
Flaga Group — Marketing Organization
- Sep 1, 1988
G & W Laboratories Inc. — Marketing Organization
- Oct 20, 1988
Marsam Pharmaceuticals — Marketing Organization
- Jan 11, 1989
Boca Pharmacal — Marketing Organization
- Jun 28, 1989
Vintage — Marketing Organization
- Sep 20, 1989
Cosette — Marketing Organization
- Sep 20, 1989
Teva — Marketing Organization
- Sep 20, 1989
ACP Nimble — Marketing Organization
- Dec 22, 1989
Abraxis — NDA Secondary Org
- Dec 29, 1989
Baxalta — NDA Secondary Org
- Dec 29, 1989
Baxter — NDA Secondary Org
1990s
- Jul 31, 1991
Watson Pharmaceuticals — Marketing Organization
- Sep 30, 1992
Paddock Laboratories — Marketing Organization
- Nov 30, 1995
Perrigo — Marketing Organization
- Sep 27, 1996
Novast Labs — Marketing Organization
- Jul 15, 1997
Wockhardt — Marketing Organization
- Jul 15, 1997
Xttrium Laboratories — Marketing Organization
- Jan 1, 1999
Earliest Phase 3 Sponsor(trial)
2000s
- Jan 28, 2000
Fougera — Marketing Organization
- Nov 27, 2000
PreCision Dermatology — NDA Secondary Org
- Nov 27, 2000
Bausch Health Companies — NDA Secondary Org
- Dec 21, 2000
Bausch Health Companies — Marketing Organization
- Feb 2, 2001
Sun Pharmaceuticals — Marketing Organization
- Jun 29, 2001
Abbott — Marketing Organization
- Jan 1, 2002
Earliest Phase 2 Sponsor(trial)
- Aug 26, 2002
Stiefel Laboratories — Marketing Organization
- Aug 26, 2002
Stiefel Laboratories — NDA Secondary Org
- Jan 1, 2003
- Mar 22, 2004
Epic Pharma Llc — Marketing Organization
- Oct 22, 2004
Mylan — NDA Secondary Org
- Nov 30, 2004
Perrigo — NDA Secondary Org
- Nov 30, 2004
Padagis Us — NDA Secondary Org
- Aug 12, 2005
Chartwell Pharmaceuticals — Marketing Organization
- Aug 12, 2005
Lannett Company, Inc. — Marketing Organization
- Nov 7, 2006
Medicis — Marketing Organization
- Mar 29, 2007
Fresenius — Marketing Organization
- Oct 23, 2008
Dow Pharmaceutical Sciences — Marketing Organization
- Aug 26, 2009
Aurobindo Pharma — Marketing Organization
2010s
- Mar 31, 2010
Padagis Us — Marketing Organization
- Jun 17, 2010
Akorn, Inc. — Marketing Organization
- Jul 16, 2010
Almirall — Marketing Organization
- Jul 16, 2010
Almirall — NDA Secondary Org
- Sep 30, 2011
Sagent Pharmaceuticals, Inc. — Marketing Organization
- May 31, 2012
Sandoz — Marketing Organization
- May 31, 2012
Novartis — Marketing Organization
- Aug 28, 2012
Lyne Laboratories — Marketing Organization
- Mar 13, 2014
Amneal Pharmaceuticals — Marketing Organization
- May 29, 2015
Apax Partners — Marketing Organization
- Jun 12, 2015
Allergan PLC (2015) — Marketing Organization
- Jun 19, 2015
Actavis — Marketing Organization
- Aug 25, 2016
Tolmar Inc. — Marketing Organization
- Dec 30, 2016
Pharmaceutical Associates — Marketing Organization
- Dec 30, 2016
Teligent Pharmaceuticals — Marketing Organization
- Apr 20, 2017
Shire — NDA Secondary Org
- May 5, 2017
Alembic — Marketing Organization
- May 5, 2017
Orit Labs Llc — Marketing Organization
- Jun 28, 2017
Shire — Marketing Organization
- Oct 10, 2017
Rising Pharmaceuticals — Marketing Organization
- Oct 10, 2017
Mylan — Marketing Organization
- Feb 8, 2018
Glasshouse Pharmaceuticals — Marketing Organization
- May 11, 2018
Heritage Pharma — Marketing Organization
- May 11, 2018
Emcure — Marketing Organization
- May 25, 2018
Taro Pharmaceuticals — Marketing Organization
- Jul 16, 2018
Zydus Discovery DMCC — Marketing Organization
- Jul 16, 2018
Cadila Healthcare — Marketing Organization
- Nov 5, 2018
Micro Labs Ltd India — Marketing Organization
- Jan 28, 2019
Encube Ethicals Pvt. Ltd. — Marketing Organization
- Mar 14, 2019
Glenmark Pharmaceuticals — Marketing Organization
- Aug 19, 2019
ANDA Repository — Marketing Organization
2020s
- Jul 29, 2020
Solaris Pharma Corp — Marketing Organization
- Apr 12, 2021
AbbVie — Marketing Organization
- Dec 7, 2021
Dare Bioscience — Marketing Organization
- Dec 7, 2021
Dare Bioscience — NDA Secondary Org
- Feb 10, 2022
Donaldson Company — Marketing Organization
Indications
Approved for
- Abdominal Abscess
- Abscess
- Acne Vulgaris
- Bone Diseases, Infectious (approved 1972)
- Empyema
- Endometritis
- Enterocolitis, Pseudomembranous
- Genital Diseases, Female
- Infections
- Intraabdominal Infections
- Irritable Bowel Syndrome
- Lung Abscess
- Osteomyelitis
- Parametritis
- Pelvic Infection (approved 1970)
- Peritonitis
- Pneumonia
- Reproductive Tract Infections (approved 1972)
- Respiratory Tract Infections
- Sepsis
- Skin and Connective Tissue Diseases (approved 1972)
- Skin Diseases, Bacterial (approved 1970)
- Soft Tissue Infections
- Vaginosis, Bacterial
Studied for
- Abdominal Abscess · Phase 2
- Abortion, Septic · Phase 4
- Abscess · Phase 4
- Amputation, Surgical · Phase 4
- Anesthesia and Analgesia · Phase 3
- Anti-Bacterial Agents · Phase 4
- Appendicitis · Phase 3
- Arm Injuries · Phase 4
- Bacteremia · Phase 4
- Bacterial Infections · Phase 4
- Bites and Stings · Phase 4
- Breast Neoplasms · Phase 3
- Burns · Phase 4
- Candidiasis · Phase 4
- Candidiasis, Vulvovaginal · Phase 3
- Carcinoma, Non-Small-Cell Lung · Phase 2
- Cellulitis · Phase 4
- Chorioretinitis · Phase 3
- Colorectal Neoplasms · Phase 1
- COVID-19 · Phase 2/Phase 3
- Delivery, Obstetric · Phase 4
- Dental Pulp · Phase 4
- Diabetes Mellitus · Phase 3
- Diabetic Foot · Phase 4
- Drug-Related Side Effects and Adverse Reactions · Phase 2
- Endocarditis · Phase 4
- Endometriosis · Phase 1
- Endometrium · Phase 4
- Endophthalmitis · Phase 4
- Exanthema · Phase 2
- Femoral Neck Fractures · Phase 3
- Focal Infection, Dental · Phase 4
- Folliculitis · Phase 4
- Fractures, Bone · Phase 4
- Fractures, Open · Phase 4
- General Surgery · Phase 4
- Glioblastoma · Phase 2
- Hand Injuries · Phase 4
- Head and Neck Neoplasms · Phase 1
- Healthy Volunteers · Phase 1
- Heart Failure · Phase 3
- Hemopneumothorax · Phase 2/Phase 3
- Hernia · Phase 3
- HIV Infections · Phase 3
- Infant, Premature, Diseases · Phase 4
- Infertility, Female · Phase 2
- Inflammation · Phase 4
- Jaw Fractures · Phase 1
- Keratosis, Actinic · Phase 2
- Kidney Calculi · Phase 3
- Malaria · Phase 3
- Methicillin-Resistant Staphylococcus aureus · Phase 3
- Nasal Obstruction · Phase 3
- Nasal Surgical Procedures · Phase 3
- Neoplasms · Phase 2
- Obesity · Phase 1
- Obstetrics · Phase 4
- Pain · Phase 3
- Periodontal Pocket · Phase 3
- Periodontitis · Phase 3
- Pneumonia · Phase 4
- Pneumonia, Pneumocystis · Phase 4
- Pneumothorax · Phase 2/Phase 3
- Postpartum Hemorrhage · Phase 4
- Postpartum Period · Phase 4
- Prediabetic State · Phase 2
- Pregnancy · Phase 4
- Premature Birth · Phase 4
- Prosthesis-Related Infections · Phase 2
- Rosacea · Phase 2/Phase 3
- Salivary Ducts · Phase 4
- Sick Sinus Syndrome · Phase 3
- Signs and Symptoms · Phase 3
- Skin Diseases · Phase 3
- Skin Diseases, Bacterial · Phase 3
- Skin Diseases, Infectious · Phase 3
- Staphylococcal Infections · Phase 4
- Surgical Wound Infection · Phase 3
- Syncope · Phase 3
- Tooth · Phase 4
- Tooth Abnormalities · Phase 4
- Traumatology · Phase 4
- Urinary Bladder Neoplasms · Phase 4
- Urinary Tract Infections · Phase 4
- Vagina · Phase 3
- Vaginal Diseases · Phase 4
- Vaginitis · Phase 3
- Vaginosis, Bacterial · Phase 4
- Vulvovaginitis · Phase 3
- Wound Infection · 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
benzaclin
with benzoyl peroxide
Also known as acanya, duac, onexton
cabtreo
with adapalene, benzoyl peroxide
ziana
with tretinoin
Also known as veltin
Approval history
- approvedFeb 22, 1970
Chemistry & pharmacology
SMILES
CCCCCCCCCCCCCCCC(=O)O[C@@H]1[C@@H](O)[C@@H](O)[C@@H]([C@H](NC(=O)[C@@H]2C[C@@H](CCC)CN2C)[C@H](C)Cl)O[C@@H]1SC.Cl- Mol. weight
- 699.87 g/mol
- Lipinski Ro5
- 2 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL1200632 ↗
- WikipediaClindamycin/benzoyl peroxide ↗
- NCATS3U02EL437C ↗
- ChEMBLCHEMBL1237086 ↗
- ChEMBLCHEMBL3184512 ↗
- WikipediaClindamycin ↗
- WikipediaBenzoyl peroxide/clindamycin ↗
- ChEMBLCHEMBL1200588 ↗
- ChEMBLCHEMBL1753 ↗
- ChEMBLCHEMBL1237120 ↗
Also known as
- 7-cdl
- 7-cdl
- 7-chloro-7-deoxylincomycin
- 7-chloro-7-deoxylincomycin palmitate
- 7-chlorolincomycin
- 7-chlorolincomycin palmitate
- 7-deoxy-7(s)-chlorolincomycin
- 7(s)-chloro-7-deoxylincomycin
- 7(s)-chloro-7-deoxylincomycin
- antirobe
- antirobe
- benzaclin
- benzaclin
- chlolincocin
- chlorodeoxylincomycin
- chlorodeoxylincomycin
- chlorolincomycin
- chlorolincomycin
- cleocin
- cleocin
- cleocin
- cleocin
- cleocin palmitate
- cleocin phosphate
- cleocin phosphate
- cleocin t
- cleocin t
- cleocin (tn)
- cleocin (tn)
- clincin
- clindagel
- clindagel
- clindagel
- clindamicina
- clindamicina
- clindamycin
- clindamycin
- clindamycin
- clindamycin
- clindamycin
- clindamycin
- clindamycin
- clindamycin
- clindamycin 2-palmitate
- clindamycin-2-phosphate
- clindamycin-2-phosphate
- clindamycine
- clindamycine
- clindamycin hcl
- clindamycin hcl
- clindamycin hcl
- clindamycin hydrochloride
- clindamycin hydrochloride
- clindamycin hydrochloride
- clindamycin hydrochloride
- clindamycin hydrochloride hydrate
- clindamycin hydrochloride hydrate
- clindamycin hydrochloride hydrate
- clindamycin hydrochloride hydrate
- clindamycin hydrochloride hydrate
- clindamycin hydrochloride hydrate
- clindamycin hydrochloride monohydrate
- clindamycin palmitate
- clindamycin palmitate
- clindamycin palmitate
- clindamycin palmitate
- clindamycin palmitate
- clindamycin palmitate
- clindamycin palmitate hcl
- clindamycin palmitate hcl
- clindamycin palmitate hcl
- clindamycin palmitate hydrochloride
- clindamycin palmitate hydrochloride
- clindamycin palmitate hydrochloride
- clindamycin palmitate hydrochloride
- clindamycin palmitate hydrochloride
- clindamycin palmitate hydrochloride
- clindamycin phosphate
- clindamycin phosphate
- clindamycin phosphate
- clindamycin phosphate
- clindamycin phosphate
- clindamycin phosphate
- clindamycin phosphate
- clindamycin phosphate
- clindamycinum
- clindamycinum
- clindesse
- clindesse
- clindesse
- clindets
- clinimycin
- dalacin
- dalacin
- dalacin c
- dalacin c
- dalacin c
- dalacin c phos
- dalacine
- dalacin t
- dalacin t
- evoclin
- evoclin
- idp-110
- lindamycin phosphate
- methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-l-2-pyrrolidinecarboxamido)-1-thio-l-threo-alpha-d-galacto-octopyranoside
- methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-l-2-pyrrolidinecarboxamido)-1-thio-l-threo-alpha-d-galacto-octopyranoside
- onexton
- sobelin
- sobelin
- sobelin
- u-21251
- u-21251
- u-25179e
- u-25179e
- u-25179-e
- u-25179-e
- u-28508
- u-28508
- zindaclin
- zindaclin
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07267013 | Phase 2 | Jan 15, 2026 | University of Nantes |
| NCT06702345 | N/A | Mar 1, 2025 | GlaxoSmithKline, Helmholtz Centre for Infection Research, Leiden University, University of Cologne, University of Oxford |
| NCT06841003 | Phase 3 | Feb 28, 2025 | Spaarne Gasthuis, ZonMw: The Netherlands Organisation for Health Research and Development |
| NCT06494072 | Phase 4 | Aug 22, 2024 | Medical College of Wisconsin |
| NCT05867654 | Phase 4 | Jul 31, 2024 | University of Louisville |
| NCT06422221 | Phase 4 | Jul 15, 2024 | Santiago de Compostela University, University of Santiago de Compostela |
| NCT06336824 | Phase 3 | Jun 28, 2024 | Clinical Research Centre, Malaysia, Government of Malaysia |
| NCT06787885 | N/A | May 1, 2024 | Fayoum University |
| NCT06120140 | Phase 2 | Mar 8, 2024 | — |
| NCT05899140 | Phase 4 | Feb 1, 2024 | University of Munster |
| NCT07247851 | N/A | Jan 10, 2024 | Ain Shams University |
| NCT05846399 | Phase 4 | Sep 7, 2023 | University of Missouri |
| NCT06616168 | Phase 1 | Sep 1, 2023 | Lviv National Medical University |
| NCT05762484 | N/A | Apr 30, 2023 | Erasmus University Rotterdam |
| NCT06172010 | Phase 4 | Apr 1, 2023 | Alrijne Hospital, Elisabeth-TweeSteden Ziekenhuis, Erasmus University Rotterdam, Isala Clinics, Zwolle, The Netherlands, Leiden University, Medical Center Leeuwarden, Onze Lieve Vrouw Hospital, Radboud University, Reade Rheumatology Research Institute, Reinier Haga Orthopedisch Centrum, Rijnstate Hospital, Spaarne Gasthuis, Tergooi Hospital, University of Amsterdam, University of Groningen |
| NCT05849090 | Early Phase 1 (Phase 1) | Mar 27, 2023 | University of Utah |
| NCT06068673 | N/A | Mar 1, 2023 | Damanhour University |
| NCT05582434 | Early Phase 1 (Phase 1) | Jan 31, 2023 | Bausch Health Companies, Wake Forest University |
| NCT05926869 | Phase 2 | Aug 1, 2022 | Jinnah Postgraduate Medical Centre, University of Karachi |
| NCT05398679 | Phase 4 | Jun 1, 2022 | University of Barcelona |
Organizations
Research & Development (282)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| GlaxoSmithKline | For profit | 26 | 8 | 5 | 2004 |
| Stiefel Laboratories | For profit | 17 | 17 | 4 | 2004 |
| Bausch Health Companies | For profit | 7 | 5 | 3 | 2017 |
| Taro Pharmaceuticals | For profit | 6 | 6 | 1 | 2012 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 5 | 5 | 3 | 1999 |
| Pfizer | For profit | 5 | 2 | 4 | 2005 |
| Leiden University | Academic/Hospital | 4 | 4 | 2 | 2018 |
| Perrigo | For profit | 4 | 4 | 2 | 2007 |
| Actavis | For profit | 3 | 3 | 2 | 2010 |
| Albert Schweitzer Hospital | Academic/Hospital | 3 | 2 | 2 | 2002 |
| Cairo University | Academic/Hospital | 3 | 3 | 3 | 2016 |
| Catawba Clinical Research | For profit | 3 | 0 | 2 | 2015 |
| Duke University | Academic/Hospital | 3 | 3 | 2 | 2013 |
| Icahn School of Medicine at Mount Sinai | Academic/Hospital | 3 | 3 | 2 | 2011 |
| Medicis | For profit | 3 | 1 | 2 | 2009 |
| Miguel Hernández University | Academic/Hospital | 3 | 3 | 1 | 2013 |
| Northwestern University | Academic/Hospital | 3 | 3 | 2 | 2010 |
| Thomas Jefferson University | Academic/Hospital | 3 | 2 | 2 | 2013 |
| University of Amsterdam | Academic/Hospital | 3 | 0 | 3 | 2012 |
| University of Barcelona | Academic/Hospital | 3 | 1 | 2 | 2010 |
Marketing (111)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ACP Nimble | For profit | MKTG | Sep 20, 1989 |
| ANDA Repository | For profit | MKTG | Aug 19, 2019 |
| AbbVie | For profit | MKTG | Apr 12, 2021 |
| Abbott | For profit | MKTG | Jun 29, 2001 |
| Abraxis | For profit | NDA2 | Dec 22, 1989 |
| Abraxis | For profit | MKTG | — |
| Actavis | For profit | MKTG | Jun 19, 2015 |
| Actavis | For profit | SYN | Jun 12, 2015 |
| Akorn, Inc. | For profit | MKTG | Jun 17, 2010 |
| Akorn, Inc. | For profit | SYN | Apr 4, 2013 |
| Alembic | For profit | MKTG | May 5, 2017 |
| Allergan PLC (2015) | For profit | MKTG | Jun 12, 2015 |
| Almaject | For profit | MKTG | Jul 24, 1987 |
| Almirall | For profit | MKTG | Jul 16, 2010 |
| Almirall | For profit | NDA2 | Jul 16, 2010 |
| Alvogen | For profit | MKTG | Jul 24, 1987 |
| Alvogen | For profit | SYN | Jul 24, 1987 |
| Amneal Pharmaceuticals | For profit | SYN | Aug 5, 2022 |
| Amneal Pharmaceuticals | For profit | MKTG | Mar 13, 2014 |
| Apax Partners | For profit | MKTG | May 29, 2015 |
| Athenex, Inc. | For profit | MKTG | — |
| Aurobindo Pharma | For profit | MKTG | Aug 26, 2009 |
| Aurobindo Pharma | For profit | SYN | Apr 30, 2013 |
| Bausch Health Companies | For profit | MKTG | Dec 21, 2000 |
| Bausch Health Companies | For profit | NDA2 | Nov 27, 2000 |
| Baxalta | For profit | NDA2 | Dec 29, 1989 |
| Baxalta | For profit | SYN | Apr 20, 2017 |
| Baxter | For profit | NDA2 | Dec 29, 1989 |
| Bedford Pharmaceuticals | For profit | MKTG | — |
| Boca Pharmacal | For profit | MKTG | Jan 11, 1989 |
| Bristol-Myers Squibb | For profit | MKTG | — |
| Cadila Healthcare | For profit | MKTG | Jul 16, 2018 |
| Chartwell Pharmaceuticals | For profit | MKTG | Aug 12, 2005 |
| Chartwell Pharmaceuticals | For profit | SYN | May 5, 2017 |
| Cosette | For profit | MKTG | Sep 20, 1989 |
| Dare Bioscience | For profit | MKTG | Dec 7, 2021 |
| Dare Bioscience | For profit | NDA2 | Dec 7, 2021 |
| Donaldson Company | For profit | MKTG | Feb 10, 2022 |
| Dow Pharmaceutical Sciences | For profit | MKTG | Oct 23, 2008 |
| Emcure | For profit | MKTG | May 11, 2018 |
| Encube Ethicals Pvt. Ltd. | For profit | MKTG | Jan 28, 2019 |
| Encube Ethicals Pvt. Ltd. | For profit | SYN | Mar 11, 2021 |
| Epic Pharma Llc | For profit | MKTG | Mar 22, 2004 |
| Flaga Group | For profit | MKTG | May 9, 1988 |
| Fougera | For profit | MKTG | Jan 28, 2000 |
| Fougera | For profit | SYN | Jun 5, 1997 |
| Fresenius | For profit | MKTG | Mar 29, 2007 |
| G & W Laboratories Inc. | For profit | MKTG | Sep 1, 1988 |
| Glasshouse Pharmaceuticals | For profit | MKTG | Feb 8, 2018 |
| Glenmark Pharmaceuticals | For profit | MKTG | Mar 14, 2019 |
| Glenmark Pharmaceuticals | For profit | SYN | Feb 10, 2021 |
| Heritage Pharma | For profit | MKTG | May 11, 2018 |
| Hikma | For profit | MKTG | Oct 15, 1987 |
| Lannett Company, Inc. | For profit | MKTG | Aug 12, 2005 |
| Lannett Company, Inc. | For profit | SYN | Aug 12, 2005 |
| Lyne Laboratories | For profit | MKTG | Aug 28, 2012 |
| Marsam Pharmaceuticals | For profit | MKTG | Oct 20, 1988 |
| Medicis | For profit | MKTG | Nov 7, 2006 |
| Micro Labs Ltd India | For profit | MKTG | Nov 5, 2018 |
| Mylan | For profit | NDA2 | Oct 22, 2004 |
| Mylan | For profit | SYN | Oct 22, 2004 |
| Mylan | For profit | MKTG | Oct 10, 2017 |
| Novartis | For profit | MKTG | May 31, 2012 |
| Novast Labs | For profit | MKTG | Sep 27, 1996 |
| Orit Labs Llc | For profit | MKTG | May 5, 2017 |
| Padagis Us | For profit | MKTG | Mar 31, 2010 |
| Padagis Us | For profit | MKTG | Sep 30, 1992 |
| Padagis Us | For profit | NDA2 | Nov 30, 2004 |
| Paddock Laboratories | For profit | SYN | Jul 7, 2010 |
| Paddock Laboratories | For profit | MKTG | Sep 30, 1992 |
| Perrigo | For profit | NDA2 | Nov 30, 2004 |
| Perrigo | For profit | SYN | Mar 31, 2010 |
| Perrigo | For profit | SYN | Sep 30, 1996 |
| Perrigo | For profit | SYN | Jun 26, 2012 |
| Perrigo | For profit | MKTG | Nov 30, 1995 |
| Pfizer | For profit | MKTG | Feb 22, 1970 |
| Pfizer | For profit | NDA2 | Feb 22, 1970 |
| Pharmaceutical Associates | For profit | MKTG | Dec 30, 2016 |
| Pharmacia & Upjohn | For profit | NDA2 | Feb 22, 1970 |
| Pharmacia & Upjohn | For profit | NDA | Jul 9, 1980 |
| Pharmacia & Upjohn | For profit | MKTG | Feb 8, 1982 |
| PreCision Dermatology | For profit | NDA2 | Nov 27, 2000 |
| Rising Pharmaceuticals | For profit | SYN | Oct 10, 2017 |
| Rising Pharmaceuticals | For profit | MKTG | Oct 10, 2017 |
| SOLOPAK | For profit | MKTG | — |
| Sagent Pharmaceuticals, Inc. | For profit | MKTG | Sep 30, 2011 |
| Sagent Pharmaceuticals, Inc. | For profit | SYN | Sep 30, 2011 |
| Sandoz | For profit | MKTG | May 31, 2012 |
| Shire | For profit | NDA2 | Apr 20, 2017 |
| Shire | For profit | MKTG | Jun 28, 2017 |
| Solaris Pharma Corp | For profit | MKTG | Jul 29, 2020 |
| Stiefel Laboratories | For profit | MKTG | Aug 26, 2002 |
| Stiefel Laboratories | For profit | NDA2 | Aug 26, 2002 |
| Sun Pharmaceuticals | For profit | MKTG | Feb 2, 2001 |
| Taro Pharmaceuticals | For profit | MKTG | May 25, 2018 |
| Taro Pharmaceuticals | For profit | SYN | Mar 31, 2004 |
| Taro Pharmaceuticals | For profit | SYN | Dec 15, 2017 |
| Taro Pharmaceuticals | For profit | SYN | Mar 11, 2020 |
| Teligent Pharmaceuticals | For profit | MKTG | Dec 30, 2016 |
| Teligent Pharmaceuticals | For profit | SYN | Dec 30, 2016 |
| Teva | For profit | MKTG | Sep 20, 1989 |
| Teva | For profit | SYN | Dec 29, 1989 |
| Tolmar Inc. | For profit | MKTG | Aug 25, 2016 |
| Vintage | For profit | MKTG | Jun 28, 1989 |
| Watson Pharmaceuticals | For profit | MKTG | Jul 31, 1991 |
| West-Ward Pharmaceutical | For profit | MKTG | Oct 15, 1987 |
| Wockhardt | For profit | MKTG | Jul 15, 1997 |
| Xttrium Laboratories | For profit | MKTG | Jul 15, 1997 |
| Zydus Discovery DMCC | For profit | MKTG | Jul 16, 2018 |
| Zydus Discovery DMCC | For profit | SYN | Jan 31, 2005 |
| Zydus Discovery DMCC | For profit | SYN | Sep 19, 2023 |