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Last Updated: March 29, 2024

Diclofenac sodium - Generic Drug Details


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What are the generic drug sources for diclofenac sodium and what is the scope of freedom to operate?

Diclofenac sodium is the generic ingredient in nine branded drugs marketed by 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, Rubicon, Sandoz, Novartis, 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, Chartwell Rx, Micro Labs, Pliva, Roxane, Teva, 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 seventy-two NDAs. There are twenty patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Diclofenac sodium has forty-two patent family members in fifteen countries.

There are twenty-one drug master file entries for diclofenac sodium. One hundred and twenty-five suppliers are listed for this compound. There are three tentative approvals for this compound.

Drug Prices for diclofenac sodium

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Drug Sales Revenue Trends for diclofenac sodium

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Recent Clinical Trials for diclofenac sodium

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

SponsorPhase
University of RijekaN/A
Fayoum University HospitalN/A
German University in CairoPhase 2

See all diclofenac sodium clinical trials

Generic filers with tentative approvals for DICLOFENAC SODIUM
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 Trial2%SOLUTION;TOPICAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for DICLOFENAC SODIUM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DYLOJECT Injection diclofenac sodium 37.5 mg/mL, 1 mL single-dose vials 022396 1 2015-12-15
PENNSAID Topical Solution diclofenac sodium 2.0% 204623 1 2014-06-03
PENNSAID Topical Solution diclofenac sodium 1.5% 020947 1 2012-07-11
SOLARAZE Topical Gel diclofenac sodium 3% 021005 1 2009-12-16

US Patents and Regulatory Information for diclofenac sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Haleon Us Holdings VOLTAREN ARTHRITIS PAIN diclofenac sodium GEL;TOPICAL 022122-001 Oct 17, 2007 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin Pharms DICLOFENAC SODIUM diclofenac sodium SOLUTION;TOPICAL 208021-001 Sep 20, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rising DICLOFENAC SODIUM diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 078553-001 Dec 28, 2007 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rubicon DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 216548-003 May 11, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vpna DICLOFENAC SODIUM diclofenac sodium TABLET, EXTENDED RELEASE;ORAL 075492-001 Feb 11, 2000 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms DICLOFENAC SODIUM diclofenac sodium SOLUTION;TOPICAL 206116-001 Sep 2, 2016 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Perrigo Pharma Intl DICLOFENAC SODIUM diclofenac sodium GEL;TOPICAL 211253-001 May 16, 2019 OTC 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

Expired US Patents for diclofenac sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Javelin Pharms Inc DYLOJECT diclofenac sodium SOLUTION;INTRAVENOUS 022396-001 Dec 23, 2014 ⤷  Try a Trial ⤷  Try a Trial
Fougera Pharms SOLARAZE diclofenac sodium GEL;TOPICAL 021005-001 Oct 16, 2000 ⤷  Try a Trial ⤷  Try a Trial
Novartis VOLTAREN diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 020037-001 Mar 28, 1991 ⤷  Try a Trial ⤷  Try a Trial
Novartis VOLTAREN diclofenac sodium TABLET, DELAYED RELEASE;ORAL 019201-001 Jul 28, 1988 ⤷  Try a Trial ⤷  Try a Trial
Fougera Pharms SOLARAZE diclofenac sodium GEL;TOPICAL 021005-001 Oct 16, 2000 ⤷  Try a Trial ⤷  Try a Trial
Novartis VOLTAREN diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 020037-001 Mar 28, 1991 ⤷  Try a Trial ⤷  Try a Trial
Novartis VOLTAREN diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 020037-001 Mar 28, 1991 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for diclofenac sodium

Country Patent Number Title Estimated Expiration
Hong Kong 1134024 DICLOFENAC GEL ⤷  Try a Trial
New Zealand 577020 DICLOFENAC GEL CONTAINING DIMETHYL SULFOXIDE (DMSO) ⤷  Try a Trial
Japan 2014005309 FORMULATION OF LOW DOSE DICLOFENAC AND &bgr;-CYCLODEXTRIN ⤷  Try a Trial
Brazil PI0709409 composição farmacêutica e método para tratar um mamìfero necessitando de analgesia ⤷  Try a Trial
Japan 2009531450 ⤷  Try a Trial
South Korea 20080112285 FORMULATIONS OF LOW DOSE DICLOFENAC AND BETA-CYCLODEXTRIN ⤷  Try a Trial
Denmark 2086504 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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