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Diclofenac
Arthrotec, Cambia, Flector, Licart, Pennsaid, Voltaren, Zipsor, Zorvolex (diclofenac) is a small molecule pharmaceutical. Diclofenac was first approved as Voltaren on 1988-07-28. It is used to treat ankylosing spondylitis, dysmenorrhea, inflammation, juvenile arthritis, and keratosis amongst others in the USA. The pharmaceutical is active against prostaglandin G/H synthase 1 and prostaglandin G/H synthase 2. In addition, it is known to target peroxisome proliferator-activated receptor gamma, acid-sensing ion channel 3, and transient receptor potential cation channel subfamily M member 3.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
nervous system diseasesD009422
eye diseasesD005128
skin and connective tissue diseasesD017437
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Cambia, Flector, Licart, Pennsaid, Voltaren, Zipsor (generic drugs available since 1996-03-26, discontinued: Cataflam, Dyloject, Solaraze, Zorvolex)
Combinations
Arthrotec (generic drugs available since 1996-03-26)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Diclofenac
Tradename
Company
Number
Date
Products
ZORVOLEXZyla Life SciencesN-204592 DISCN2013-10-18
2 products, RLD
Hide discontinued
Diclofenac epolamine
Tradename
Company
Number
Date
Products
LICARTIBSA GroupN-206976 RX2018-12-19
1 products, RLD, RS
FLECTORIBSA GroupN-021234 RX2007-01-31
1 products, RLD, RS
Diclofenac potassium
Tradename
Company
Number
Date
Products
CAMBIAAssertio TherapeuticsN-022165 RX2009-06-17
1 products, RLD, RS
ZIPSORAssertio TherapeuticsN-022202 RX2009-06-16
1 products, RLD, RS
Show 1 discontinued
Diclofenac sodium
Tradename
Company
Number
Date
Products
VOLTAREN ARTHRITIS PAINGSKN-022122 OTC2007-10-17
1 products, RLD, RS
PENNSAIDHorizon PharmaceuticalN-204623 RX2014-01-16
1 products, RLD, RS
Show 7 discontinued
Diclofenac sodium
+
Misoprostol
Tradename
Company
Number
Date
Products
ARTHROTECMylanN-020607 RX1997-12-24
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
arthrotecNew Drug Application2021-08-13
cambiaNew Drug Application2021-04-30
cataflamANDA2021-07-29
dermacinrx lexitral pharmapakunapproved drug other2023-05-04
flectorNew Drug Application2021-11-11
licartNew Drug Application2021-12-09
pennsaidNew Drug Application2022-02-08
voltarenANDA2023-03-31
zipsorNew Drug Application2021-04-30
zorvolexNew Drug Application2019-09-02
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
ankylosing spondylitisEFO_0003898D013167M45
dysmenorrheaHP_0100607D004412N94.6
inflammationMP_0001845D007249—
juvenile arthritisEFO_0002609D001171M08
keratosis—D007642—
osteoarthritisEFO_0002506D010003M15-M19
photophobia—D020795H53.14
rheumatoid arthritisEFO_0000685D001172M06.9
Agency Specific
FDA
EMA
Expiration
Code
DICLOFENAC POTASSIUM, ZIPSOR, ASSERTIO
2024-05-25NPP
Patent Expiration
Patent
Expires
Flag
FDA Information
Diclofenac Epolamine, Licart, Ibsa Inst Bio
113445202035-02-20U-3393
113511332035-02-20U-3393
Diclofenac Sodium, Pennsaid, Horizon
85464502030-08-09U-1435, U-1436
82170782029-07-10U-1248, U-1477
86181642029-07-10U-1477
87419562029-07-10U-1435
93705012029-07-10U-1614
93754122029-07-10U-1614
94150292029-07-10U-1614
82528382028-04-21DPU-1489
85636132027-10-17DPU-1488
88718092027-10-17U-1614
90669132027-10-17DPU-1488
91015912027-10-17DPU-1488
91321102027-10-17U-1488
91683042027-10-17DP
91683052027-10-17U-1488
92207842027-10-17U-1488
93395512027-10-17U-1488
93395522027-10-17DPU-1488
95393352027-10-17U-1614
Diclofenac, Zorvolex, Zyla
86795442030-04-23DP
89993872030-04-23U-55
90177212030-04-23DP
91738542030-04-23DP
91800952030-04-23U-55
91800962030-04-23DP
91863282030-04-23U-55
Diclofenac Potassium, Zipsor, Assertio
76628582029-02-24U-1035
78840952029-02-24U-1111
79395182029-02-24U-980
81106062029-02-24U-980
86239202029-02-24U-1482
95612002029-02-24U-1482
Diclofenac Sodium, Dyloject, Javelin Pharms Inc
89462922027-03-22U-1659
Diclofenac Potassium, Cambia, Assertio
77593942026-06-16DS, DPU-436
80976512026-06-16DS, DPU-436
89276042026-06-16U-436
98271972026-06-16DP
ATC Codes
D: Dermatologicals
— D11: Other dermatological preparations in atc
— D11A: Other dermatological preparations in atc
— D11AX: Other dermatological preparations in atc
— D11AX18: Diclofenac
M: Musculo-skeletal system drugs
— M01: Antiinflammatory and antirheumatic products
— M01A: Antiinflammatory and antirheumatic products, non-steroids
— M01AB: Acetic acid derivatives and related substances
— M01AB05: Diclofenac
— M01AB55: Diclofenac, combinations
— M02: Topical products for joint and muscular pain
— M02A: Topical products for joint and muscular pain
— M02AA: Antiinflammatory preparations, non-steroids for topical use
— M02AA15: Diclofenac
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01B: Antiinflammatory agents, ophthalmologic
— S01BC: Antiinflammatory agents, non-steroidal, ophthalmologic
— S01BC03: Diclofenac
— S01C: Antiinflammatory agents and antiinfectives in combination
— S01CC: Antiinflammatory agents, non-steroids and antiinfectives in combination
— S01CC01: Diclofenac and antiinfectives
HCPCS
Code
Description
J1130
Injection, diclofenac sodium, 0.5 mg
Clinical
Clinical Trials
9 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Postoperative painD010149G89.18———123
Patient-controlled analgesiaD016058———1—1
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AnaplasiaD000708————11
BronchoscopyD001999————11
ColonoscopyD003113————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDICLOFENAC
INNdiclofenac
Description
Diclofenac is a monocarboxylic acid consisting of phenylacetic acid having a (2,6-dichlorophenyl)amino group at the 2-position. It has a role as a non-narcotic analgesic, an antipyretic, an EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor, a xenobiotic, an environmental contaminant, a drug allergen and a non-steroidal anti-inflammatory drug. It is a secondary amino compound, an amino acid, a dichlorobenzene, an aromatic amine and a monocarboxylic acid. It is functionally related to a phenylacetic acid and a diphenylamine. It is a conjugate acid of a diclofenac(1-).
Classification
Small molecule
Drug classanti-inflammatory agents (acetic acid derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
O=C(O)Cc1ccccc1Nc1c(Cl)cccc1Cl
Identifiers
PDB4OJ4
CAS-ID15307-86-5
RxCUI3355
ChEMBL IDCHEMBL139
ChEBI ID47381
PubChem CID3033
DrugBankDB00586
UNII ID144O8QL0L1 (ChemIDplus, GSRS)
Target
Agency Approved
PTGS1
PTGS1
PTGS2
PTGS2
Organism
Homo sapiens
Gene name
PTGS1
Gene synonyms
COX1
NCBI Gene ID
5742
Protein name
prostaglandin G/H synthase 1
Protein synonyms
COX-1, Cyclooxygenase-1, PGH synthase 1, PGHS-1, PHS 1, Prostaglandin H2 synthase 1, Prostaglandin-endoperoxide synthase 1, prostaglandin-endoperoxide synthase 1 (prostaglandin G/H synthase and cyclooxygenase)
Uniprot ID
Q5T7T8
Mouse ortholog
Ptgs1 (19224)
prostaglandin G/H synthase 1 (P22437)
Alternate
PPARG
PPARG
ASIC3
ASIC3
TRPM3
TRPM3
Organism
Homo sapiens
Gene name
PPARG
Gene synonyms
NR1C3
NCBI Gene ID
5468
Protein name
peroxisome proliferator-activated receptor gamma
Protein synonyms
Nuclear receptor subfamily 1 group C member 3, peroxisome proliferator-activated receptor-gamma 5, peroxisome proliferator-activated receptor-gamma splicing, PPAR-gamma
Uniprot ID
Q96J12
Mouse ortholog
Pparg (19016)
peroxisome proliferator-activated receptor gamma (P37238)
Variants
Clinical Variant
No data
Financial
Diclofenac - Amneal Pharmaceuticals
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Diclofenac - Novartis
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Zipsor - Assertio Therapeutics
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Zipsor - Assertio Therapeutics
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Cambia - Assertio Therapeutics
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Cambia - Assertio Therapeutics
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Arthrotec - Pfizer
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 30,732 documents
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Safety
Black-box Warning
Black-box warning for: Arthrotec, Cambia, Cataflam, Dermacinrx lexitral pharmapak, Flector, Licart, Pennsaid, Voltaren, Zipsor, Zorvolex
Adverse Events
Top Adverse Reactions
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27 adverse events reported
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