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Diclofenac potassium - Generic Drug Details

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What are the generic drug sources for diclofenac potassium and what is the scope of diclofenac potassium freedom to operate?

Diclofenac potassium is the generic ingredient in four branded drugs marketed by Bionpharma Inc, Depomed Inc, Par Form, Novartis, Apotex, Casi Pharms Inc, Mylan, Sandoz, Sun Pharm Industries, Teva, and Watson Labs Teva, and is included in twelve NDAs. There are twelve patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Diclofenac potassium has fifty-four patent family members in twenty-nine countries.

There are forty-seven drug master file entries for diclofenac potassium. Twenty-one suppliers are listed for this compound.

Summary for diclofenac potassium

International Patents:	54
US Patents:	12
Tradenames:	4
Applicants:	11
NDAs:	12
Drug Master File Entries:	47
Suppliers / Packagers:	21
Bulk Api Vendors:	36
Clinical Trials:	885
Patent Applications:	3,161
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for diclofenac potassium
DailyMed Link:	diclofenac potassium at DailyMed

Pharmacology for diclofenac potassium

Ingredient-type	Nonsteroidal Anti-inflammatory Compounds
Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Decreased Prostaglandin Production

Synonyms for diclofenac potassium

15307-81-0

15307-86-5 (Parent)

2-((2,6-dichlorophenyl)amino)benzeneacetic acid, monopotassium salt

AB0013318

AC-18735

AK163133

AKOS015889752

AKOS015994733

AN-8291

Benzeneacetic acid, 2-((2,6-dichlorophenyl)amino)-, monopotassium salt

C14H10Cl2KNO2

C14H10Cl2NO2.K

Cambia

Cambia (TN)

Cataflam

Cataflam (TN)

CGP 45840B

CGP-45840B

CHEBI:4508

CHEMBL1200804

D00903

Diclofenac potassium (USAN)

Diclofenac potassium [USAN:USP]

Diclofenac potassium [USAN]

Diclofenic potassium

DR001603

DTXSID30165212

FT-0603076

H866

HMS3656D18

I01-3215

KS-5037

KXZOIWWTXOCYKR-UHFFFAOYSA-M

L4D5UA6CB4

LS-173441

MolPort-005-937-655

Potassium (o-(2,6-dichloroanilino)phenyl)acetate

potassium {2-[(2,6-dichlorophenyl)amino]phenyl}acetate

potassium 2-(2-((2,6-dichlorophenyl)amino)phenyl)acetate

potassium 2-[2-(2,6-dichloroanilino)phenyl]acetate

potassium;2-[2-(2,6-dichloroanilino)phenyl]acetate

PubChem5895

s3062

SC-01315

SCHEMBL40784

ST51051764

UNII-L4D5UA6CB4

Voltfast

Zipsor

Zipsor (TN)

US Patents and Regulatory Information for diclofenac potassium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs Teva	DICLOFENAC POTASSIUM	diclofenac potassium	TABLET;ORAL	075152-001	Nov 27, 1998		DISCN	No	No
Sandoz	DICLOFENAC POTASSIUM	diclofenac potassium	TABLET;ORAL	075582-001	Feb 23, 2001		DISCN	No	No
Novartis	CATAFLAM	diclofenac potassium	TABLET;ORAL	020142-002	Nov 24, 1993		DISCN	No	No
Depomed Inc	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	AB	RX	Yes	Yes

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Expired US Patents for diclofenac potassium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Depomed Inc	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009
Depomed Inc	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009

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International Patents for diclofenac potassium

Country	Document Number	Estimated Expiration
Canada	2632375
Taiwan	200740470
Norway	20020208
World Intellectual Property Organization (WIPO)	0113897