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Last Updated: April 18, 2024

Diclofenac sodium - Generic Drug Details

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

Diclofenac sodium is the generic ingredient in nine branded drugs marketed by Actavis Mid Atlantic, Alembic, Amneal, Amneal Pharms, Aurolife Pharma Llc, Cipla, Encube, Glenmark Pharms Ltd, Hikma, Padagis Israel, Perrigo Pharma Intl, Taro, Fougera Pharms, Haleon Us Holdings, Akorn, Altaire Pharms Inc, Bausch And Lomb, Falcon Pharms, Rising, Rubicon, Sandoz, Novartis, Javelin Pharms Inc, Apotex, Epic Pharma Llc, Lupin Ltd, Lupin Pharms, Novel Labs Inc, Pai Holdings Pharm, Twi Pharms, Watson Labs Inc, Zydus Lifesciences, Horizon, Nuvo Pharms Inc, Actavis Elizabeth, Aurobindo Pharma Usa, Carlsbad, Chartwell Rx, Micro Labs, Pliva, Roxane, Teva, Teva Pharms, Unique, Dexcel Ltd, Riconpharma Llc, Vpna, Pfizer, Actavis Labs Fl Inc, Exela Holdings, Yung Shin Pharm, and Zydus Pharms, and is included in seventy-two NDAs. There are twenty patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Diclofenac sodium has forty-two patent family members in fifteen countries.

There are twenty-one drug master file entries for diclofenac sodium. One hundred and twenty-five suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for diclofenac sodium

International Patents:	42
US Patents:	20
Tradenames:	9
Applicants:	52
NDAs:	72
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	125
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	141
Patent Applications:	7,170
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for diclofenac sodium
Drug Sales Revenues:	Drug sales revenues for diclofenac sodium
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for diclofenac sodium
What excipients (inactive ingredients) are in diclofenac sodium?	diclofenac sodium excipients list
DailyMed Link:	diclofenac sodium at DailyMed

See drug prices for diclofenac sodium

Drug Sales Revenue Trends for diclofenac sodium

See drug sales revenues for diclofenac sodium

Recent Clinical Trials for diclofenac sodium

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

Sponsor	Phase
University of Rijeka	N/A
Fayoum University Hospital	N/A
German University in Cairo	Phase 2

See all diclofenac sodium clinical trials

Generic filers with tentative approvals for DICLOFENAC SODIUM

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	1.5% W/W	SOLUTION;TOPICAL
⤷ Try a Trial	⤷ Try a Trial	2%	SOLUTION;TOPICAL
⤷ Try a Trial	⤷ Try a Trial	2%	SOLUTION;TOPICAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for diclofenac sodium

Drug Class	Nonsteroidal Anti-inflammatory Drug Anti-coagulant Calculi Dissolution Agent
Mechanism of Action	Cyclooxygenase Inhibitors Acidifying Activity Calcium Chelating Activity
Physiological Effect	Decreased Prostaglandin Production Decreased Coagulation Factor Activity

Paragraph IV (Patent) Challenges for DICLOFENAC SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DYLOJECT	Injection	diclofenac sodium	37.5 mg/mL, 1 mL single-dose vials	022396	1	2015-12-15
PENNSAID	Topical Solution	diclofenac sodium	2.0%	204623	1	2014-06-03
PENNSAID	Topical Solution	diclofenac sodium	1.5%	020947	1	2012-07-11
SOLARAZE	Topical Gel	diclofenac sodium	3%	021005	1	2009-12-16

US Patents and Regulatory Information for diclofenac sodium

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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
Glenmark Pharms Ltd	DICLOFENAC SODIUM	diclofenac sodium	GEL;TOPICAL	208301-001	Sep 13, 2016	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Twi Pharms	DICLOFENAC SODIUM	diclofenac sodium	SOLUTION;TOPICAL	202393-001	Nov 24, 2014		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Nuvo Pharms Inc	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	020947-001	Nov 4, 2009		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus Lifesciences	DICLOFENAC SODIUM	diclofenac sodium	SOLUTION;TOPICAL	206411-001	Apr 17, 2018	AT	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Actavis Elizabeth	DICLOFENAC SODIUM	diclofenac sodium	TABLET, EXTENDED RELEASE;ORAL	075910-001	Jan 7, 2002		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Horizon	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	204623-001	Jan 16, 2014	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Alembic	DICLOFENAC SODIUM	diclofenac sodium	SOLUTION;TOPICAL	212506-001	Nov 29, 2022	AB	RX	No	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 sodium

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fougera Pharms	SOLARAZE	diclofenac sodium	GEL;TOPICAL	021005-001	Oct 16, 2000	⤷ Try a Trial	⤷ Try a Trial
Fougera Pharms	SOLARAZE	diclofenac sodium	GEL;TOPICAL	021005-001	Oct 16, 2000	⤷ Try a Trial	⤷ Try a Trial
Fougera Pharms	SOLARAZE	diclofenac sodium	GEL;TOPICAL	021005-001	Oct 16, 2000	⤷ Try a Trial	⤷ Try a Trial
Fougera Pharms	SOLARAZE	diclofenac sodium	GEL;TOPICAL	021005-001	Oct 16, 2000	⤷ Try a Trial	⤷ Try a Trial
Javelin Pharms Inc	DYLOJECT	diclofenac sodium	SOLUTION;INTRAVENOUS	022396-001	Dec 23, 2014	⤷ Try a Trial	⤷ Try a Trial
Novartis	VOLTAREN	diclofenac sodium	SOLUTION/DROPS;OPHTHALMIC	020037-001	Mar 28, 1991	⤷ Try a Trial	⤷ Try a Trial
Fougera Pharms	SOLARAZE	diclofenac sodium	GEL;TOPICAL	021005-001	Oct 16, 2000	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for diclofenac sodium

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Country	Patent Number	Title	Estimated Expiration
China	104606126	DICLOFENAC GEL	⤷ Try a Trial
European Patent Office	2004203	FORMULATIONS DE DICLOFÉNAC ET DE CYCLODEXTRINE BÊTA À FAIBLE DOSAGE (FORMULATIONS OF LOW DOSE DICLOFENAC AND BETA-CYCLODEXTRIN)	⤷ Try a Trial
Australia	2007311019	Diclofenac gel	⤷ Try a Trial
Mexico	2008012495	FORMULACIONES DE DOSIS BAJA DE DICLOFENACO Y BETA-CICLODEXTRINA. (FORMULATIONS OF LOW DOSE DICLOFENAC AND BETA-CYCLODEXTRIN.)	⤷ Try a Trial
European Patent Office	2522343	Formulations de faible dose du diclofénac et de beta-cyclodextrine (Formulations of Low Dose Diclofenac and Beta-Cyclodextrin)	⤷ Try a Trial
Russian Federation	2463038	ДИКЛОФЕНАКОВЫЙ ГЕЛЬ (DICLOFENAC GEL)	⤷ Try a Trial
Israel	198161	ג'ל דיכלופני (Diclofenac gel)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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