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Last Updated: May 18, 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.

Drug Prices for DICLOFENAC

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Drug Sales Revenue Trends for DICLOFENAC

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DICLOFENAC
Generic Entry Date for DICLOFENAC*:
Constraining patent/regulatory exclusivity:

*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

National Trauma CenterN/A
ZetrOZ, Inc.Phase 1
University of the PacificPhase 3

See all DICLOFENAC clinical trials

Generic filers with tentative approvals for DICLOFENAC
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial1.5% W/WSOLUTION;TOPICAL
⤷  Try a Trial⤷  Try a Trial2%SOLUTION;TOPICAL
⤷  Try a Trial⤷  Try a 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.

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
Amneal DICLOFENAC SODIUM diclofenac sodium GEL;TOPICAL 200936-001 Oct 28, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Horizon PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nuvo Pharms Inc PENNSAID diclofenac sodium SOLUTION;TOPICAL 020947-001 Nov 4, 2009 DISCN Yes 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

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