You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 28, 2024

Diclofenac potassium - Generic Drug Details

✉ Email this page to a colleague

« Back to Dashboard

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 Aurobindo Pharma Ltd, Bionpharma, Strides Pharma, Assertio, Alkem Labs Ltd, Annora Pharma, Par Form, Amici, Novartis, Chartwell Rx, Novast Labs, Rk Pharma, Rubicon, Senores Pharms, Sun Pharm Industries, Teva, Umedica, and Watson Labs Teva, and is included in nineteen 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. Thirty-five suppliers are listed for this compound.

Summary for diclofenac potassium

International Patents:	34
US Patents:	10
Tradenames:	4
Applicants:	18
NDAs:	19
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	33
Patent Applications:	6,778
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
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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Strides Pharma	DICLOFENAC POTASSIUM	diclofenac potassium	CAPSULE;ORAL	210078-001	Dec 3, 2019	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Assertio	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Alkem Labs Ltd	DICLOFENAC POTASSIUM	diclofenac potassium	FOR SOLUTION;ORAL	216635-001	Jul 20, 2022	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm Industries	DICLOFENAC POTASSIUM	diclofenac potassium	TABLET;ORAL	075470-001	Feb 21, 2002		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Novartis	CATAFLAM	diclofenac potassium	TABLET;ORAL	020142-002	Nov 24, 1993		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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

Subscribe to access the full database, or Try a Trial
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 a Trial	⤷ Try a Trial
Assertio	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	⤷ Try a Trial	⤷ Try a Trial
Assertio	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	⤷ Try a Trial	⤷ Try a Trial
Assertio	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for diclofenac potassium

Subscribe to access the full database, or Try a Trial
Country	Patent Number	Title	Estimated Expiration
Canada	2632375	PREPARATIONS DE DICLOFENAC ET LEURS METHODES D'UTILISATION (DICLOFENAC FORMULATIONS AND METHODS OF USE)	⤷ Try a Trial
European Patent Office	2402003	Formulations de diclofénac et procédés d'utilisation (Diclofenac formulations and methods of use)	⤷ Try a Trial
South Korea	20080024202	DICLOFENAC FORMULATIONS AND METHODS OF USE	⤷ Try a Trial
Portugal	1890680		⤷ Try a Trial
Norway	20080352		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

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.