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Last Updated: February 26, 2021

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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 patent protection?

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.

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
Theodor Bilharz Research InstitutePhase 4
Joanneum Research Forschungsgesellschaft mbHN/A
Olakunle Ifeoluwa MakindeN/A

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Generic filers with tentative approvals for DICLOFENAC
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial1.5% W/WSOLUTION;TOPICAL
  Start Trial  Start Trial2%SOLUTION;TOPICAL
  Start Trial  Start Trial35MGCAPSULE;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 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   Start Trial   Start Trial   Start Trial
Horizon PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Horizon PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis VOLTAREN diclofenac sodium TABLET, DELAYED RELEASE;ORAL 019201-002 Jul 28, 1988 DISCN Yes No   Start Trial   Start Trial   Start Trial
Lupin Ltd DICLOFENAC SODIUM diclofenac sodium SOLUTION;TOPICAL 204132-001 Aug 20, 2015 AT RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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.