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Last Updated: April 19, 2024

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, Ibsa, Ibsa Inst Bio, 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, Watson Labs Teva, 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, Sandoz, 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, Micro Labs, Pliva, Roxane, 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 ninety-four NDAs. There are thirty-nine 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. There are four tentative approvals for this compound.

Summary for DICLOFENAC

International Patents:	44
US Patents:	39
Tradenames:	16
Applicants:	69
NDAs:	94
Drug Master File Entries:	47
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	419
Patent Applications:	7,122
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
What excipients (inactive ingredients) are in DICLOFENAC?	DICLOFENAC excipients list
DailyMed Link:	DICLOFENAC at DailyMed

See drug prices for DICLOFENAC

Drug Sales Revenue Trends for DICLOFENAC

See drug sales revenues for DICLOFENAC

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DICLOFENAC

Generic Entry Date for DICLOFENAC^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial Dosage: CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for DICLOFENAC

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

Sponsor	Phase
National Trauma Center	N/A
ZetrOZ, Inc.	Phase 1
University of the Pacific	Phase 3

See all DICLOFENAC clinical trials

Generic filers with tentative approvals for DICLOFENAC

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	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.

Medical Subject Heading (MeSH) Categories for DICLOFENAC

Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors

Paragraph IV (Patent) Challenges for DICLOFENAC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZORVOLEX	Capsules	diclofenac	18 mg and 35 mg	204592	1	2014-06-06

US Patents and Regulatory Information for DICLOFENAC

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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
Actavis Elizabeth	DICLOFENAC SODIUM	diclofenac sodium	TABLET, DELAYED RELEASE;ORAL	074514-002	Mar 26, 1996	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zyla	ZORVOLEX	diclofenac	CAPSULE;ORAL	204592-002	Oct 18, 2013		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Rubicon	DICLOFENAC SODIUM	diclofenac sodium	TABLET, DELAYED RELEASE;ORAL	216548-001	May 11, 2023	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

International Patents for DICLOFENAC

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Country	Patent Number	Title	Estimated Expiration
China	104161743	A novel formulation of diclofenac	⤷ Try a Trial
Mexico	337619	UNA FORMULACION NOVEDOSA DE DICLOFENACO. (A NOVEL FORMULATION OF DICLOFENAC.)	⤷ Try a Trial
South Korea	101580656		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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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.