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 Aurobindo Pharma Ltd, Bionpharma, Strides Pharma, Assertio, Alkem Labs Ltd, Annora Pharma, Endo Operations, Taro, Amici Pharma, Novartis, Chartwell Rx, Novast Labs, Rk Pharma, Rubicon, Senores Pharms, Sun Pharm Industries, Teva, Umedica, and Watson Labs Teva, and is included in twenty 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-four patent family members in twenty-three countries.

There are eleven drug master file entries for diclofenac potassium. Forty-one suppliers are listed for this compound.

Summary for diclofenac potassium

International Patents:	34
US Patents:	10
Tradenames:	4
Applicants:	19
NDAs:	20
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	41
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	33
Patent Applications:	6,823
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
Danish Headache Center	Phase 4
Fayoum University Hospital	Phase 4
Cairo University	N/A

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	Strength	NDA	ANDAs Submitted	Submissiondate
ZIPSOR	Capsules	diclofenac potassium	25 mg	022202	1	2012-11-14
CAMBIA	Oral Solution (Sachet)	diclofenac potassium	50 mg	022165	1	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
Assertio	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	AB	RX	Yes	Yes	8,927,604	⤷ Subscribe				⤷ Subscribe
Alkem Labs Ltd	DICLOFENAC POTASSIUM	diclofenac potassium	FOR SOLUTION;ORAL	216635-001	Jul 20, 2022	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Novast Labs	DICLOFENAC POTASSIUM	diclofenac potassium	TABLET;ORAL	215585-001	Oct 8, 2021	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Assertio	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	AB	RX	Yes	Yes	8,097,651	⤷ Subscribe	Y	Y		⤷ Subscribe
>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	6,974,595	⤷ Subscribe
Assertio	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	6,287,594	⤷ Subscribe
Assertio	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	7,482,377	⤷ Subscribe
Assertio	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	6,365,180	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for diclofenac potassium

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1890680	PREPARATIONS DE DICLOFENAC ET LEURS METHODES D'UTILISATION (DICLOFENAC FORMULATIONS AND METHODS OF USE)	⤷ Subscribe
European Patent Office	2402003	Formulations de diclofénac et procédés d'utilisation (Diclofenac formulations and methods of use)	⤷ Subscribe
Spain	2912897		⤷ Subscribe
China	112755014	双氯芬酸制剂和使用方法 (DICLOFENAC FORMULATIONS AND METHODS OF USE)	⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

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