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
Trade Name
FDA
EMA
Cambia, Flector, Licart, Pennsaid, Voltaren, Zipsor (generic drugs available since 1996-03-26, discontinued: Cataflam, Dyloject, Solaraze, Zorvolex)
CombinationsArthrotec (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 |
---|---|---|---|---|
ZORVOLEX | Zyla Life Sciences | N-204592 DISCN | 2013-10-18 | 2 products, RLD |
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Diclofenac epolamine
Diclofenac potassium
Diclofenac sodium
Diclofenac sodium
+
Misoprostol
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
ARTHROTEC | Mylan | N-020607 RX | 1997-12-24 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
arthrotec | New Drug Application | 2021-08-13 |
cambia | New Drug Application | 2021-04-30 |
cataflam | ANDA | 2021-07-29 |
dermacinrx lexitral pharmapak | unapproved drug other | 2023-05-04 |
flector | New Drug Application | 2021-11-11 |
licart | New Drug Application | 2021-12-09 |
pennsaid | New Drug Application | 2022-02-08 |
voltaren | ANDA | 2023-03-31 |
zipsor | New Drug Application | 2021-04-30 |
zorvolex | New Drug Application | 2019-09-02 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
ankylosing spondylitis | EFO_0003898 | D013167 | M45 |
dysmenorrhea | HP_0100607 | D004412 | N94.6 |
inflammation | MP_0001845 | D007249 | — |
juvenile arthritis | EFO_0002609 | D001171 | M08 |
keratosis | — | D007642 | — |
osteoarthritis | EFO_0002506 | D010003 | M15-M19 |
photophobia | — | D020795 | H53.14 |
rheumatoid arthritis | EFO_0000685 | D001172 | M06.9 |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
DICLOFENAC POTASSIUM, ZIPSOR, ASSERTIO | |||
2024-05-25 | NPP |
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Diclofenac Epolamine, Licart, Ibsa Inst Bio | |||
11344520 | 2035-02-20 | U-3393 | |
11351133 | 2035-02-20 | U-3393 | |
Diclofenac Sodium, Pennsaid, Horizon | |||
8546450 | 2030-08-09 | U-1435, U-1436 | |
8217078 | 2029-07-10 | U-1248, U-1477 | |
8618164 | 2029-07-10 | U-1477 | |
8741956 | 2029-07-10 | U-1435 | |
9370501 | 2029-07-10 | U-1614 | |
9375412 | 2029-07-10 | U-1614 | |
9415029 | 2029-07-10 | U-1614 | |
8252838 | 2028-04-21 | DP | U-1489 |
8563613 | 2027-10-17 | DP | U-1488 |
8871809 | 2027-10-17 | U-1614 | |
9066913 | 2027-10-17 | DP | U-1488 |
9101591 | 2027-10-17 | DP | U-1488 |
9132110 | 2027-10-17 | U-1488 | |
9168304 | 2027-10-17 | DP | |
9168305 | 2027-10-17 | U-1488 | |
9220784 | 2027-10-17 | U-1488 | |
9339551 | 2027-10-17 | U-1488 | |
9339552 | 2027-10-17 | DP | U-1488 |
9539335 | 2027-10-17 | U-1614 | |
Diclofenac, Zorvolex, Zyla | |||
8679544 | 2030-04-23 | DP | |
8999387 | 2030-04-23 | U-55 | |
9017721 | 2030-04-23 | DP | |
9173854 | 2030-04-23 | DP | |
9180095 | 2030-04-23 | U-55 | |
9180096 | 2030-04-23 | DP | |
9186328 | 2030-04-23 | U-55 | |
Diclofenac Potassium, Zipsor, Assertio | |||
7662858 | 2029-02-24 | U-1035 | |
7884095 | 2029-02-24 | U-1111 | |
7939518 | 2029-02-24 | U-980 | |
8110606 | 2029-02-24 | U-980 | |
8623920 | 2029-02-24 | U-1482 | |
9561200 | 2029-02-24 | U-1482 | |
Diclofenac Sodium, Dyloject, Javelin Pharms Inc | |||
8946292 | 2027-03-22 | U-1659 | |
Diclofenac Potassium, Cambia, Assertio | |||
7759394 | 2026-06-16 | DS, DP | U-436 |
8097651 | 2026-06-16 | DS, DP | U-436 |
8927604 | 2026-06-16 | U-436 | |
9827197 | 2026-06-16 | DP |
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 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | DICLOFENAC |
INN | diclofenac |
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 class | anti-inflammatory agents (acetic acid derivatives) |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | O=C(O)Cc1ccccc1Nc1c(Cl)cccc1Cl |
Target
Agency Approved
PTGS1
PTGS1
PTGS2
PTGS2
Organism
Homo sapiens
Gene name
PTGS1
Gene synonyms
COX1
NCBI Gene ID
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
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
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
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
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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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