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.
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Commercial
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Drug Products
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EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| diclofenac epolamine | NDA authorized generic | 2026-01-05 |
| flector | New Drug Application | 2025-10-21 |
| licart | New Drug Application | 2026-04-02 |
| pennsaid | New Drug Application | 2010-10-01 |
| zipsor | New Drug Application | 2025-09-03 |
Indications
FDA
EMA
No data
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
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Clinical
Clinical Trials
577 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 pain | D010149 | — | G89.18 | — | — | 2 | 1 | — | 3 |
| Hip osteoarthritis | D015207 | EFO_1000786 | M16 | — | — | 1 | 1 | — | 2 |
| Low back pain | D017116 | — | M54.5 | — | — | 1 | 1 | — | 2 |
| Ankylosing spondylitis | D013167 | EFO_0003898 | M45 | — | — | 1 | 1 | — | 2 |
| Sprains and strains | D013180 | — | — | — | — | — | 2 | — | 2 |
| Spondylarthritis | D025241 | — | — | — | — | — | 1 | — | 1 |
| Spondylitis | D013166 | — | M46.9 | — | — | — | 1 | — | 1 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | 1 | — | 1 |
| Back pain | D001416 | — | M54 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | — | 4 | — | — | 4 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | — | 2 | — | — | 2 |
| Cancer pain | D000072716 | — | G89.3 | — | — | 1 | — | — | 1 |
| Chronic pain | D059350 | — | — | — | — | 1 | — | — | 1 |
| Renal colic | D056844 | EFO_1001412 | N23 | — | — | 1 | — | — | 1 |
| Colic | D003085 | — | R10.83 | — | — | 1 | — | — | 1 |
Indications Phases 2
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Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inflammation | D007249 | MP_0001845 | — | — | — | — | — | 1 | 1 |
| Glaucoma | D005901 | EFO_0000516 | H40 | — | — | — | — | 1 | 1 |
| Open-angle glaucoma | D005902 | EFO_0004190 | H40.1 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Diclofenac epolamine |
| 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.OCCN1CCCC1 |
Identifiers
| PDB | — |
| CAS-ID | 15307-86-5 |
| RxCUI | 3355 |
| ChEMBL ID | CHEMBL1201180 |
| ChEBI ID | 48296 |
| PubChem CID | 3033 |
| DrugBank | DB00586 |
| UNII ID | 144O8QL0L1 (ChemIDplus, GSRS) |
Target
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Financial
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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
Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 384 documents
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Safety
Black-box Warning
Black-box warning for: Diclofenac epolamine, Flector, Licart, Pennsaid, Zipsor
Adverse Events
Top Adverse Reactions
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5,822 adverse events reported
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