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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Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

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Completion date

Results first post date

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Commercial

Therapeutic Areas

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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)

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

Tradename	Company	Number	Date	Products
LICART	IBSA Group	N-206976 RX	2018-12-19	1 products, RLD, RS
FLECTOR	IBSA Group	N-021234 RX	2007-01-31	1 products, RLD, RS

Diclofenac potassium

Tradename	Company	Number	Date	Products
CAMBIA	Assertio Therapeutics	N-022165 RX	2009-06-17	1 products, RLD, RS
ZIPSOR	Assertio Therapeutics	N-022202 RX	2009-06-16	1 products, RLD, RS

Show 1 discontinued

Diclofenac sodium

Tradename	Company	Number	Date	Products
VOLTAREN ARTHRITIS PAIN	GSK	N-022122 OTC	2007-10-17	1 products, RLD, RS
PENNSAID	Horizon Pharmaceutical	N-204623 RX	2014-01-16	1 products, RLD, RS

Show 7 discontinued

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
aleve arthritis pain gel	ANDA	2023-11-30
arthritis pain	ANDA	2023-06-09
arthritis pain reliever	ANDA	2023-11-17
arthritis pain relieving	ANDA	2023-05-15
arthrotec	New Drug Application	2023-08-16
aspercreme arthritis	ANDA	2023-10-11
basic care arthritis pain	ANDA	2022-01-06
berkley and jensen arthritis pain	ANDA	2023-07-26
calcipotriene 0.005% / diclofenac sodium 3% / hyaluronic acid sodium salt 2% / niacinamide 2%	unapproved drug other	2019-05-06
cambia	New Drug Application	2021-04-30

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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

No data

Clinical

Clinical Trials

489 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pain	D010146	EFO_0003843	R52	8	6	9	13	15	51
Postoperative pain	D010149	—	G89.18	—	4	8	7	17	36
Osteoarthritis	D010003	EFO_0002506	M15-M19	1	4	18	6	6	35
Knee osteoarthritis	D020370	EFO_0004616	M17	3	8	11	4	6	30
Healthy volunteers/patients	—	—	—	11	—	—	2	3	16
Low back pain	D017116	HP_0003419	M54.5	—	1	4	6	2	13
Actinic keratosis	D055623	—	L57.0	1	—	5	5	1	12
Pulpitis	D011671	EFO_1001139	K04.0	—	4	3	3	3	10
Acute pain	D059787	—	R52	—	1	6	1	2	9
Ankle injuries	D016512	—	S93.4	—	2	4	1	2	8

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Inflammation	D007249	MP_0001845	—	3	—	2	—	2	7
Breast neoplasms	D001943	EFO_0003869	C50	2	—	1	—	1	4
Dysmenorrhea	D004412	HP_0100607	N94.6	—	1	1	—	3	4
Soft tissue injuries	D017695	—	—	—	1	2	—	1	4
Dental pins	D003772	—	—	—	1	2	—	—	3
Sciatica	D012585	HP_0011868	M54.3	—	—	1	—	2	3
Rotator cuff injuries	D000070636	—	M75.1	—	2	2	—	—	2
Tennis elbow	D013716	EFO_1001896	M77.1	—	2	1	—	—	2
Procedural pain	D000073818	—	—	—	—	2	—	—	2
Cancer pain	D000072716	—	G89.3	—	—	1	—	—	1

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Arthritis	D001168	HP_0001369	M05-M14	1	2	—	—	1	4
Gout	D006073	EFO_0004274	M10	—	1	—	—	1	2
Neoplasms	D009369	—	C80	1	1	—	—	—	2
Shoulder pain	D020069	HP_0030834	M25.51	—	1	—	—	1	2
Skin neoplasms	D012878	EFO_0004198	C44	—	2	—	—	—	2
Bursitis	D002062	EFO_1000941	M71.9	—	1	—	—	1	2
Urolithiasis	D052878	—	N20-N23	1	1	—	—	1	2
Chronic disease	D002908	—	—	—	1	—	—	—	1
Rhinitis	D012220	EFO_0008521	J31	—	1	—	—	—	1
Gouty arthritis	D015210	—	—	—	1	—	—	—	1

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Uveitis	D014605	HP_0000554	H20.9	1	—	—	—	1	2
Therapeutic equivalency	D013810	—	—	2	—	—	—	—	2
Aging	D000375	GO_0007568	R41.81	1	—	—	—	—	1
Carpal tunnel syndrome	D002349	EFO_0004143	G56.0	1	—	—	—	—	1
Chronic renal insufficiency	D051436	—	N18	1	—	—	—	—	1
Hepatic insufficiency	D048550	—	—	1	—	—	—	—	1
Pharmacokinetics	D010599	—	—	1	—	—	—	—	1
Biological availability	D001682	—	—	1	—	—	—	—	1
Asymptomatic diseases	D058070	—	—	1	—	—	—	—	1
Covid-19	D000086382	—	U07.1	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pathologic dilatation	D004108	—	—	—	—	—	—	3	3
Keratoconus	D007640	EFO_0004223	H18.6	—	—	—	—	3	3
Regeneration	D012038	—	—	—	—	—	—	3	3
Headache	D006261	HP_0002315	R51	—	—	—	—	2	2
Trismus	D014313	—	—	—	—	—	—	2	2
Obesity	D009765	EFO_0001073	E66.9	—	—	—	—	2	2
Cataract	D002386	HP_0000518	H26.9	—	—	—	—	2	2
Pancreatic neoplasms	D010190	EFO_0003860	C25	—	—	—	—	2	2
Wounds and injuries	D014947	—	T14.8	—	—	—	—	2	2
Rib fractures	D012253	—	—	—	—	—	—	2	2

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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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Variants

No data

Financial

Revenue by drug

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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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Estimated US medical usage

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Trends

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Safety

Black-box Warning

Black-box warning for: Arthrotec, Cambia, Capsinac, Cataflam, Clofenax, Dermacinrx lexitral pharmapak, Dermacinrx lexitral pharmapak ii, Dfs 1.5%/ms 25%/menth 6%/cap 0.025% pak, Dfs 75mg dr/ms 25%/menth 6%/cap 0.025% pak, Diclareal topical kit, Diclofenac, Diclofenac epolamine, Diclofenac potassium, Diclofenac potassium for oral solution, Diclofenac sodium, 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, Diclosaicin, Diclostream, Diclotral pak, Diclotrex, Diclovix, Diclovix cm, Diclovix m, Diclozor, Dimentho, Flector, Flexipak, Iclofenac cp, Inavix, Inflatherm, Lefluniclo, Lextol, Licart, Lofena, Nudiclo solupak, Nudiclo tabpak, Nudroxipak dsdr-50, Nudroxipak dsdr-75, Pennsaid, Previdolrx analgesic pak, Previdolrx plus analgesic pak, Profinac, Solaravix, Varophen, Venngel one, Xrylix, Ziclopro, Zipsor, Zorvolex

Adverse Events

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72,409 adverse events reported

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