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Last Updated: November 2, 2024

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, Ibsa, Ibsa Inst Bio, Aurobindo Pharma Ltd, Bionpharma, Strides Pharma, Assertio, Alkem Labs Ltd, Annora Pharma, Endo Operations, Taro, 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, Fougera Pharms, Haleon Us Holdings, Altaire Pharms Inc, Bausch And Lomb, Falcon Pharms, Rising, Sandoz, Sciegen Pharms Inc, 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-five 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.

Drug Prices for diclofenac

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*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
assertio Therapeutics, IncPhase 1/Phase 2
University of Texas Southwestern Medical CenterPhase 1/Phase 2
Washington State UniversityEarly Phase 1

See all diclofenac clinical trials

Generic filers with tentative approvals for DICLOFENAC
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up1.5% W/WSOLUTION;TOPICAL
⤷  Sign Up⤷  Sign Up2%SOLUTION;TOPICAL
⤷  Sign Up⤷  Sign Up35MGCAPSULE;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
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
Carlsbad DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 075185-001 Nov 13, 1998 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apotex DICLOFENAC SODIUM diclofenac sodium SOLUTION;TOPICAL 202027-001 May 27, 2014 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Unique DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 090066-002 Dec 1, 2010 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Micro Labs DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 074986-002 Feb 26, 1999 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zyla ZORVOLEX diclofenac CAPSULE;ORAL 204592-002 Oct 18, 2013 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Ibsa Inst Bio LICART diclofenac epolamine SYSTEM;TOPICAL 206976-001 Dec 19, 2018 RX Yes Yes ⤷  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

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) ⤷  Sign Up
Denmark 2421525 ⤷  Sign Up
South Korea 20150018647 A NOVEL FORMULATION OF NAPROXEN ⤷  Sign Up
Mexico 2011011222 UNA FORMULACION NOVEDOSA DE DICLOFENACO. (A NOVEL FORMULATION OF DICLOFENAC.) ⤷  Sign Up
Hong Kong 1231383 雙氯芬酸的新劑型 (A NOVEL FORMULATION OF DICLOFENAC) ⤷  Sign Up
Malaysia 168079 A NOVEL FORMULATION OF DICLOFENAC ⤷  Sign Up
>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.