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Last Updated: November 30, 2022

Diclofenac - Generic Drug Details


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

Diclofenac is the generic ingredient in sixteen branded drugs marketed by Zyla, Inst Biochem, Ibsa Inst Bio, Aurobindo Pharma Ltd, Bionpharma Inc, Strides Pharma, Assertio, Alkem Labs Ltd, Annora Pharma, Par Form, Amici, Novartis, Novast Labs, Rk Pharma, Rubicon, Sandoz, Sun Pharm Industries, Teva, Umedica Labs Pvt Ltd, Watson Labs Teva, Actavis Mid Atlantic, Akorn, Aleor Dermaceuticals, Amneal Pharms, Aurolife Pharma Llc, Cipla, Encube, Glenmark Pharms Ltd, Padagis Israel, Perrigo Pharma Intl, Taro, Tolmar, Fougera Pharms, Glaxosmithkline Cons, Altaire Pharms Inc, Bausch And Lomb, Falcon Pharms, Rising, Sandoz Inc, Javelin Pharms Inc, Amneal, Apotex, Apotex Inc, Cadila, Lupin Ltd, Lupin Pharms, Novel Labs Inc, Pai Holdings Pharm, Twi Pharms, Watson Labs Inc, Horizon, Nuvo Pharms Inc, Actavis Elizabeth, Aurobindo Pharma Usa, Carlsbad, Chartwell Rx, Micro Labs, Pliva, Roxane, Teva Pharms, Unique Pharm Labs, Dexcel Ltd, Mylan, Riconpharma Llc, Vpna, Pfizer, Actavis Labs Fl Inc, Exela Holdings, and Yung Shin Pharm, and is included in eighty-nine 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. One supplier is listed for this compound. There are four tentative approvals for this compound.

Drug Prices for diclofenac

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Drug Sales Revenue Trends for diclofenac

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Recent Clinical Trials for diclofenac

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SponsorPhase
Almirall, S.A.Phase 4
Pakistan Kidney and Liver Institute and Research CenterN/A
Loma Linda UniversityPhase 3

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Generic filers with tentative approvals for DICLOFENAC
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing1.5% W/WSOLUTION;TOPICAL
See Plans and PricingSee Plans and Pricing2%SOLUTION;TOPICAL
See Plans and PricingSee Plans and Pricing35MGCAPSULE;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
Medical Subject Heading (MeSH) Categories for diclofenac
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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zyla ZORVOLEX diclofenac CAPSULE;ORAL 204592-002 Oct 18, 2013 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Actavis Mid Atlantic DICLOFENAC SODIUM diclofenac sodium GEL;TOPICAL 206493-001 Dec 2, 2015 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Taro DICLOFENAC SODIUM diclofenac sodium GEL;TOPICAL 206298-001 Apr 28, 2016 AB RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Taro DICLOFENAC SODIUM diclofenac sodium SOLUTION;TOPICAL 203818-001 Nov 26, 2014 AT RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis VOLTAREN diclofenac sodium TABLET, DELAYED RELEASE;ORAL 019201-002 Jul 28, 1988 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Assertio ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

Country Patent Number Title Estimated Expiration
China 106727477 双氯芬酸的新剂型 (A new formation of diclofenac) See Plans and Pricing
Singapore 175314 A NOVEL FORMULATION OF DICLOFENAC See Plans and Pricing
Denmark 2421525 See Plans and Pricing
New Zealand 595987 A novel formulation of diclofenac See Plans and Pricing
Japan 6154846 See Plans and Pricing
South Korea 20150086563 디클로페낙의 신규 제형 (A NOVEL FORMULATION OF DICLOFENAC) See Plans and Pricing
>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.