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DICLOFENAC - Generic Drug Details

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What are the generic sources for diclofenac and what is the scope of freedom to operate?

Diclofenac is the generic ingredient in sixteen branded drugs marketed by Zyla, Inst Biochem, Ibsa Inst Bio, Bionpharma Inc, Strides Pharma, Assertio, Par Form, Novartis, Amici, Rk Pharma, Rubicon, Sandoz, Sun Pharm Industries, Teva, Watson Labs Teva, Actavis Mid Atlantic, Akorn, Amneal Pharms, Cipla, Encube, Glenmark Pharms Ltd, Mylan, Perrigo Uk Finco, Taro, Tolmar, Fougera Pharms, Glaxosmithkline Cons, Altaire Pharms Inc, Bausch And Lomb, Falcon Pharms, Rising, Sandoz Inc, Mylan Labs Ltd, Javelin Pharms Inc, Apotex Inc, Cadila, Lupin Ltd, Novast Labs, Novel Labs Inc, Teligent, Twi Pharms, Watson Labs Inc, Horizon, Nuvo Pharms Inc, Actavis Elizabeth, Carlsbad, Chartwell Rx, Micro Labs Usa, Mylan Pharms Inc, Pliva, Roxane, Teva Pharms, Unique Pharm Labs, Dexcel Ltd, Vpna, Pfizer, Actavis Labs Fl Inc, Exela Holdings, and Yung Shin Pharm, and is included in seventy-six NDAs. There are thirty-seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Diclofenac has forty-four patent family members in twenty-three countries.

There are forty-seven drug master file entries for diclofenac. One supplier is listed for this compound. There are seven tentative approvals for this compound.

Summary for DICLOFENAC

International Patents:	44
US Patents:	37
Tradenames:	16
Applicants:	59
NDAs:	76
Drug Master File Entries:	47
Suppliers / Packagers:	1
Bulk Api Vendors:	92
Clinical Trials:	373
Patent Applications:	6,706
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for DICLOFENAC
Drug Sales Revenues:	Drug sales revenues for DICLOFENAC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DICLOFENAC
DailyMed Link:	DICLOFENAC at DailyMed

See drug prices for DICLOFENAC

See drug sales revenues for DICLOFENAC

Recent Clinical Trials for DICLOFENAC

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

Sponsor	Phase
Theodor Bilharz Research Institute	Phase 4
Joanneum Research Forschungsgesellschaft mbH	N/A
Olakunle Ifeoluwa Makinde	N/A

See all DICLOFENAC clinical trials

Generic filers with tentative approvals for DICLOFENAC

Applicant	Application No.	Strength	Dosage Form
		1.5% W/W	SOLUTION;TOPICAL
		2%	SOLUTION;TOPICAL
		35MG	CAPSULE;ORAL

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

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Decreased Prostaglandin Production

Medical Subject Heading (MeSH) Categories for DICLOFENAC

Anti-Inflammatory Agents, Non-Steroidal

Cyclooxygenase Inhibitors

Paragraph IV (Patent) Challenges for DICLOFENAC

Tradename	Dosage	Ingredient	NDA	Submissiondate
ZORVOLEX	CAPSULE;ORAL	diclofenac	204592	2014-06-06

US Patents and Regulatory Information for DICLOFENAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Akorn	DICLOFENAC SODIUM	diclofenac sodium	GEL;TOPICAL	209484-001	Nov 21, 2018	AB	RX	No	No
Horizon	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	204623-001	Jan 16, 2014		RX	Yes	Yes			Y
Horizon	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	204623-001	Jan 16, 2014		RX	Yes	Yes
Novartis	VOLTAREN	diclofenac sodium	TABLET, DELAYED RELEASE;ORAL	019201-002	Jul 28, 1988		DISCN	Yes	No
Lupin Ltd	DICLOFENAC SODIUM	diclofenac sodium	SOLUTION;TOPICAL	204132-001	Aug 20, 2015	AT	RX	No	No
Actavis Labs Fl Inc	DICLOFENAC SODIUM AND MISOPROSTOL	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	201089-002	Jul 9, 2012	AB	RX	No	No
Glenmark Pharms Ltd	DICLOFENAC SODIUM	diclofenac sodium	GEL;TOPICAL	208301-001	Sep 13, 2016	AB	RX	No	No

International Patents for DICLOFENAC

Country	Patent Number	Estimated Expiration
Mexico	347290
New Zealand	710383
Australia	2014208310
China	106420667
China	104161743
Denmark	2421525
Eurasian Patent Organization	201171285