PharmaKB logo
Company Reports
Company Reports
Drug Reports
Drug Reports
Disease Reports
Disease Reports
Sets
Sets
Favorites
Favorites
Log in
Log in
AboutPricing
Drug ReportsDiclofenac epolamine
Diclofenac epolamine
Arthrotec, Cambia, Cataflam, Diclofenac, Flector, Licart, Voltaren, Zipsor, Zorvolex (diclofenac epolamine) is a small molecule pharmaceutical. Diclofenac epolamine was first approved as Voltaren on 1988-07-28.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Plot placeholder
Mock data
Subscribe for the real data
Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Cambia, Cataflam, Diclofenac potassium, Zipsor (discontinued: Cataflam, Diclofenac potassium)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Diclofenac potassium
Tradename
Company
Number
Date
Products
ZIPSORAssertio TherapeuticsN-022202 RX2009-06-16
1 products, RLD, RS
CAMBIAAssertio TherapeuticsN-022165 RX2009-06-17
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
aleve arthritis pain gelANDA2023-11-30
amazon basic care arthritis painANDA2024-05-17
arthritis painANDA2024-11-12
arthritis pain relieverANDA2024-06-14
arthritis pain relievingANDA2023-05-15
arthrotecNew Drug Application2023-08-16
aspercreme arthritisANDA2023-10-11
basic care arthritis painANDA2022-01-06
berkley and jensen arthritis painANDA2023-07-26
calcipotriene 0.005% / diclofenac sodium 3% / hyaluronic acid sodium salt 2% / niacinamide 2%unapproved drug other2019-05-06
Show 87 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
516 clinical trials
View more details
Plot placeholder
Mock data
Subscribe for the real data
Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ankle injuriesD016512—S93.4——1——1
Acute painD059787—R52——1——1
Sprains and strainsD013180————1——1
Actinic keratosisD055623—L57.0——1——1
KeratosisD007642————1——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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)Loading
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
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Cambia – Assertio Therapeutics
Plot placeholder
Mock data
Subscribe for the real data
Plot placeholder
Mock data
Subscribe for the real data
Cambia – Assertio Therapeutics
Plot placeholder
Mock data
Subscribe for the real data
Plot placeholder
Mock data
Subscribe for the real data
Zipsor – Assertio Therapeutics
Plot placeholder
Mock data
Subscribe for the real data
Plot placeholder
Mock data
Subscribe for the real data
Zipsor – Assertio Therapeutics
Plot placeholder
Mock data
Subscribe for the real data
Plot placeholder
Mock data
Subscribe for the real data
Arthrotec – Pfizer
Plot placeholder
Mock data
Subscribe for the real data
Plot placeholder
Mock data
Subscribe for the real data
Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Plot placeholder
Mock data
Subscribe for the real data
Additional graphs summarizing 37,124 documents
View more details
Safety
Black-box Warning
Black-box warning for: Arthrotec, Cambia, Capsinac, Cataflam, Clofenax, Diclofenac, Diclofenac epolamine, Diclofenac potassium, Diclofenac potassium for oral solution, Diclofenac sodium 1.5%, Diclofenac sodium and misoprostol, Diclofenac sodium d/r, Diclofenac sodium delayed release, Diclofenac sodium diclofenac sodium, Diclofenac sodium extended-release, Diclofenac sodium gel, Diclofenac sodium misoprostol, Diclofenac sodium topical sol, Diclofenac sodium topical solution, Diclofenac sodium/misoprostol, Diclogen, Diclosaicin, Diclostream, Diclotral pak, Diclovix, Diclovix cm, Diclovix m, Diclozor, Dimentho, Fenovar, Flector, Flexipak, Iclofenac cp, Inavix, Inflatherm, Lefluniclo, Lextol, Licart, Lixofen, Lofena, Pennsaid, Previdolrx analgesic pak, Previdolrx plus analgesic pak, Profinac, Solaravix, Varophen, Venngel one, Ziclopro, Zipsor, Zorvolex
Adverse Events
Top Adverse Reactions
Plot placeholder
Mock data
Subscribe for the real data
96,080 adverse events reported
View more details
© 2020-2024 Collaborative Drug Discovery Inc. (CDD) | Terms of Use