DICLOFENAC SODIUM - Generic Drug Details

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What are the generic 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, Altaire Pharms Inc, Bausch And Lomb, Falcon Pharms, Rising, Rubicon, Sandoz, Sciegen Pharms Inc, 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-nine 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:	129
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	145
Patent Applications:	7,113
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

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Recent Clinical Trials for DICLOFENAC SODIUM

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

Sponsor	Phase
Jamia Millia Islamia	N/A
University of Rijeka	N/A
Fayoum University Hospital	N/A

See all DICLOFENAC SODIUM clinical trials

Generic filers with tentative approvals for DICLOFENAC SODIUM

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	1.5% W/W	SOLUTION;TOPICAL
⤷ Sign Up	⤷ Sign Up	2%	SOLUTION;TOPICAL
⤷ Sign Up	⤷ Sign Up	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
Rubicon	DICLOFENAC SODIUM	diclofenac sodium	TABLET, DELAYED RELEASE;ORAL	216548-001	May 11, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	DICLOFENAC SODIUM	diclofenac sodium	TABLET, DELAYED RELEASE;ORAL	074390-001	Aug 15, 1996		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Micro Labs	DICLOFENAC SODIUM	diclofenac sodium	TABLET, DELAYED RELEASE;ORAL	074986-001	Feb 26, 1999		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-002	Dec 24, 1997	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Perrigo Pharma Intl	DICLOFENAC SODIUM	diclofenac sodium	GEL;TOPICAL	211253-001	May 16, 2019		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Horizon	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	204623-001	Jan 16, 2014		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taro	DICLOFENAC SODIUM	diclofenac sodium	SOLUTION;TOPICAL	208098-001	Sep 29, 2022	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 SODIUM

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	VOLTAREN	diclofenac sodium	TABLET, DELAYED RELEASE;ORAL	019201-001	Jul 28, 1988	⤷ Sign Up	⤷ Sign Up
Javelin Pharms Inc	DYLOJECT	diclofenac sodium	SOLUTION;INTRAVENOUS	022396-001	Dec 23, 2014	⤷ Sign Up	⤷ Sign Up
Fougera Pharms	SOLARAZE	diclofenac sodium	GEL;TOPICAL	021005-001	Oct 16, 2000	⤷ Sign Up	⤷ Sign Up
Fougera Pharms	SOLARAZE	diclofenac sodium	GEL;TOPICAL	021005-001	Oct 16, 2000	⤷ Sign Up	⤷ Sign Up
Fougera Pharms	SOLARAZE	diclofenac sodium	GEL;TOPICAL	021005-001	Oct 16, 2000	⤷ Sign Up	⤷ Sign Up
Falcon Pharms	DICLOFENAC SODIUM	diclofenac sodium	SOLUTION/DROPS;OPHTHALMIC	020809-001	May 4, 1998	⤷ Sign Up	⤷ Sign Up
Falcon Pharms	DICLOFENAC SODIUM	diclofenac sodium	SOLUTION/DROPS;OPHTHALMIC	020809-001	May 4, 1998	⤷ Sign Up	⤷ Sign Up
>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
Israel	222432	תערובות של תרופות דקלופנאק וביתא-ציקלודקסטרין במינון נמוך (Formulations of low dose diclofenac and beta-cyclodextrin)	⤷ Sign Up
Japan	5823093		⤷ Sign Up
China	101410123	Formulations of low dose diclofenac and beta-cyclodextrin	⤷ Sign Up
Canada	2647348	FORMULATIONS DE DICLOFENAC ET DE CYCLODEXTRINE BETA A FAIBLEDOSAGE (FORMULATIONS OF LOW DOSE DICLOFENAC AND BETA-CYCLODEXTRIN)	⤷ Sign Up
South Africa	200808115	FORMULATIONS OF LOW DOSE DICLOFENAC AND BETA-CYCLODEXTRIN	⤷ Sign Up
Japan	6265964		⤷ Sign Up
Japan	2009531450		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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