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Diclofenac potassium - Generic Drug Details

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, Assertio, 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.

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

US Patents:	12
Tradenames:	4
Applicants:	11
NDAs:	12
Drug Master File Entries:	47
Suppliers / Packagers:	19
Bulk Api Vendors:	38
Clinical Trials:	19
Patent Applications:	3,235
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for diclofenac potassium
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for diclofenac potassium
DailyMed Link:	diclofenac potassium at DailyMed

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

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)

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	CATAFLAM	diclofenac potassium	TABLET;ORAL	020142-002	Nov 24, 1993		DISCN	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Assertio	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	AB	RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Par Form	DICLOFENAC POTASSIUM	diclofenac potassium	FOR SOLUTION;ORAL	202964-001	May 2, 2016	AB	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Assertio	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	AB	RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y	Y		➤ Sign Up
Assertio	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	AB	RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

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