Diclofenac potassium - Generic Drug Details

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What are the generic sources for diclofenac potassium and what is the scope of patent protection?

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. Sixteen 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:	16
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
Amici	CATAFLAM	diclofenac potassium	TABLET;ORAL	076561-001	Mar 18, 2004	AB	RX	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Par Form	DICLOFENAC POTASSIUM	diclofenac potassium	FOR SOLUTION;ORAL	202964-001	May 2, 2016	AB	RX	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Novartis	CATAFLAM	diclofenac potassium	TABLET;ORAL	020142-002	Nov 24, 1993		DISCN	Yes	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				⤷ Try it Free
Rubicon	DICLOFENAC POTASSIUM	diclofenac potassium	TABLET;ORAL	075229-002	Sep 16, 2021	AB	RX	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Novartis	CATAFLAM	diclofenac potassium	TABLET;ORAL	020142-001	Nov 24, 1993		DISCN	Yes	No	⤷ 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	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	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
European Patent Office	2705837	⤷ Try it Free
New Zealand	564002	⤷ Try it Free
Peru	20070074	⤷ Try it Free
Ecuador	SP077989	⤷ Try it Free
European Patent Office	3103441	⤷ Try it Free
>Country	>Patent Number	>Estimated Expiration

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