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Last Updated: October 23, 2021

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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 freedom to operate?

Diclofenac potassium is the generic ingredient in four branded drugs marketed by Bionpharma Inc, Strides Pharma, Assertio, Par Form, Amici, Novartis, Rk Pharma, Rubicon, Sandoz, Sun Pharm Industries, Teva, and Watson Labs Teva, and is included in thirteen NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Diclofenac potassium has thirty-three patent family members in twenty-three countries.

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

Summary for diclofenac potassium

International Patents:	33
US Patents:	10
Tradenames:	4
Applicants:	12
NDAs:	13
Drug Master File Entries:	47
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	30
Patent Applications:	3,961
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for diclofenac potassium
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for diclofenac potassium
What excipients (inactive ingredients) are in diclofenac potassium?	diclofenac potassium excipients list
DailyMed Link:	diclofenac potassium at DailyMed

See drug prices for diclofenac potassium

Recent Clinical Trials for diclofenac potassium

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Fayoum University Hospital	Phase 4
Cairo University	N/A
Gesellschaft für Therapieforschung mbH	Phase 3

See all diclofenac potassium clinical trials

Pharmacology for diclofenac potassium

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

Paragraph IV (Patent) Challenges for DICLOFENAC POTASSIUM

Tradename	Dosage	Ingredient	NDA	Submissiondate
ZIPSOR	CAPSULE;ORAL	diclofenac potassium	022202	2012-11-14
CAMBIA	FOR SOLUTION;ORAL	diclofenac potassium	022165	2011-01-24

US Patents and Regulatory Information for diclofenac potassium

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Glossary

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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
Sun Pharm Industries	DICLOFENAC POTASSIUM	diclofenac potassium	TABLET;ORAL	075470-001	Feb 21, 2002		DISCN	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Assertio	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	AB	RX	Yes	Yes	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Assertio	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	AB	RX	Yes	Yes	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Sandoz	DICLOFENAC POTASSIUM	diclofenac potassium	TABLET;ORAL	075582-001	Feb 23, 2001		DISCN	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Assertio	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	AB	RX	Yes	Yes	⤷ Try it Free	⤷ Try it Free	Y	Y		⤷ Try it Free
Assertio	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	AB	RX	Yes	Yes	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for diclofenac potassium

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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	⤷ Try it Free	⤷ Try it Free
Assertio	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	⤷ Try it Free	⤷ Try it Free
Assertio	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	⤷ Try it Free	⤷ Try it Free
Assertio	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	⤷ Try it Free	⤷ Try it Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for diclofenac potassium

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Country	Patent Number	Estimated Expiration
Russian Federation	2432160	⤷ Try it Free
Spain	2717879	⤷ Try it Free
Jordan	3352	⤷ Try it Free
Canada	2932603	⤷ Try it Free
Turkey	201706038	⤷ Try it Free
Poland	1890680	⤷ Try it Free
>Country	>Patent Number	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.