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Diclofenac epolamine
Arthrotec, Cambia, Flector, Licart, Pennsaid, Voltaren, Zipsor, Zorvolex (diclofenac epolamine) is a small molecule pharmaceutical. Diclofenac epolamine was first approved as Voltaren on 1988-07-28. It is known to target peroxisome proliferator-activated receptor gamma, prostaglandin G/H synthase 2, prostaglandin G/H synthase 1, and acid-sensing ion channel 3.
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Commercial
Therapeutic Areas
No data
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
diclofenac epolamineNDA authorized generic2023-04-11
flectorNew Drug Application2021-04-16
licartNew Drug Application2020-10-01
pennsaidNew Drug Application2022-02-08
up and up arthritis pain relieverANDA2023-06-07
voltarenANDA2023-03-31
zipsorNew Drug Application2021-04-30
Show 1 more
Indications
FDA
EMA
No data
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
No data
Clinical
Clinical Trials
337 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PainD010146EFO_0003843R5276813842
OsteoarthritisD010003EFO_0002506M15-M19—4165227
Knee osteoarthritisD020370EFO_0004616M172792423
Postoperative painD010149G89.18—284519
Healthy volunteers/patients—10——1314
Actinic keratosisD055623L57.01165114
Low back painD017116HP_0003419M54.5—125210
PulpitisD011671EFO_1001139K04.0—43329
Ankle injuriesD016512S93.4—24128
Ankylosing spondylitisD013167EFO_0003898M45——24—6
Show 50 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Acute painD059787R52—16——6
InflammationD0072493—1—15
Soft tissue injuriesD017695—12—14
Dental pinsD003772—12——3
SciaticaD012585HP_0011868M54.3——1—12
DysmenorrheaD004412HP_0100607N94.6—11—12
Procedural painD000073818——2——2
MyalgiaD063806HP_0003326M79.1——1——1
SunburnD013471EFO_0003958L55——1——1
ColicD003085HP_0011848R10.83——1——1
Show 16 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GoutD006073EFO_0004274M10—1——12
Skin neoplasmsD012878EFO_0004198C44—2———2
Gouty arthritisD015210—1———1
Basal cell neoplasmsD018295—1———1
NeoplasmsD009369C80—1———1
Chronic periodontitisD055113EFO_0006343K05.311———1
Chronic painD059350HP_0012532—1———1
Musculoskeletal painD059352—1———1
Chronic kidney failureD007676EFO_0003884N18.6—1———1
ArthralgiaD018771HP_0002829M25.5—1———1
Show 4 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C502———13
ArthritisD001168EFO_0005856M05-M141———12
UveitisD014605EFO_1001231H20.91———12
AgingD000375GO_0007568R41.811————1
Carpal tunnel syndromeD002349EFO_0004143G56.01————1
Therapeutic equivalencyD0138101————1
Chronic renal insufficiencyD051436N181————1
Hepatic insufficiencyD0485501————1
PharmacokineticsD0105991————1
Biological availabilityD0016821————1
Show 5 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CataractD002386EFO_0001059H26.9————22
Pathologic dilatationD004108————22
KeratoconusD007640EFO_0004223H18.6————22
RegenerationD012038————22
Diabetic retinopathyD003930EFO_0003770————22
HemostasisD006487————11
Erectile dysfunctionD007172EFO_0004234F52.21————11
HeadacheD006261HP_0002315R51————11
TendinopathyD052256EFO_1001434M77.9————11
SynovitisD013585EFO_0008997M67.5————11
Show 24 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDICLOFENAC EPOLAMINE
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.OCCN1CCCC1
Identifiers
PDB—
CAS-ID15307-86-5
RxCUI3355
ChEMBL IDCHEMBL1201180
ChEBI ID48296
PubChem CID3033
DrugBankDB00586
UNII ID144O8QL0L1 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
PPARG
PPARG
PTGS2
PTGS2
PTGS1
PTGS1
ASIC3
ASIC3
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
Zipsor - Assertio Therapeutics
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Zipsor - Assertio Therapeutics
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Arthrotec - Pfizer
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Cambia - Assertio Therapeutics
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Cambia - Assertio Therapeutics
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 31,248 documents
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Safety
Black-box Warning
Black-box warning for: Arthrotec, Cambia, Cataflam, Diclofenac epolamine, Flector, Licart, Pennsaid, Voltaren, Zipsor, Zorvolex
Adverse Events
Top Adverse Reactions
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72,409 adverse events reported
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