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 Aurobindo Pharma Ltd, Bionpharma, Strides Pharma, Assertio, Alkem Labs Ltd, Annora Pharma, Endo Operations, Taro, Amici, 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-two 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:	42
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	33
Patent Applications:	6,778
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	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Annora Pharma	DICLOFENAC POTASSIUM	diclofenac potassium	FOR SOLUTION;ORAL	215375-001	Mar 4, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs Teva	DICLOFENAC POTASSIUM	diclofenac potassium	TABLET;ORAL	075152-001	Nov 27, 1998		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Rx	DICLOFENAC POTASSIUM	diclofenac potassium	TABLET;ORAL	075582-001	Feb 23, 2001		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
Rubicon	DICLOFENAC POTASSIUM	diclofenac potassium	TABLET;ORAL	075229-002	Sep 16, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Senores Pharms	DICLOFENAC POTASSIUM	diclofenac potassium	TABLET;ORAL	215787-001	Mar 15, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	⤷ Sign Up	⤷ Sign Up
Assertio	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	⤷ Sign Up	⤷ Sign Up
Assertio	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 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

International Patents for DICLOFENAC POTASSIUM

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Country	Patent Number	Title	Estimated Expiration
New Zealand	564002	Diclofenac formulations and methods of use	⤷ Sign Up
Russian Federation	2008101784	СОСТАВЫ, СОДЕРЖАЩИЕ ДИКЛОФЕНАК, И СПОСОБЫ ИХ ПРИМЕНЕНИЯ	⤷ Sign Up
Spain	2717879		⤷ Sign Up
Taiwan	200740470	Diclofenac formulations and methods of use	⤷ Sign Up
China	101272768	Diclofenac formulations and methods of use	⤷ Sign Up
Hong Kong	1213814	雙氯芬酸製劑和使用方法 (DICLOFENAC FORMULATIONS AND METHODS OF USE)	⤷ Sign Up
South Korea	20080024202	DICLOFENAC FORMULATIONS AND METHODS OF USE	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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