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Last Updated: March 28, 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 patent protection?

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
Novartis VOLTAREN diclofenac sodium TABLET, DELAYED RELEASE;ORAL 019201-001 Jul 28, 1988 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurolife Pharma Llc DICLOFENAC SODIUM diclofenac sodium SOLUTION;TOPICAL 213040-001 Feb 3, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Roxane DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 074391-002 Jun 29, 1995 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal DICLOFENAC SODIUM diclofenac sodium SOLUTION;TOPICAL 208198-001 Aug 18, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Unique DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 077863-003 Jun 8, 2007 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Micro Labs DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 074986-002 Feb 26, 1999 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 200158-002 May 9, 2013 AB RX 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
South Korea 20170123724 저 투여량의 디클로페낙 및 베타-사이클로덱스트린 제형 (- FORMULATIONS OF LOW DOSE DICLOFENAC AND BETA-CYCLODEXTRIN) ⤷  Try a Trial
European Patent Office 2522344 Formulations de faible dose du diclofénac et de beta-cyclodextrine (Formulations of Low Dose Diclofenac and Beta-Cyclodextrin) ⤷  Try a Trial
South Korea 20160033796 저 복용량의 디클로페낙 및 베타-사이클로덱스트린 제형 (FORMULATIONS OF LOW DOSE DICLOFENAC AND BETA-CYCLODEXTRIN) ⤷  Try a Trial
China 102846585 Formulations of low dose diclofenac and beta-cyclodextrin ⤷  Try a Trial
South Korea 20150050595 저 복용량의 디클로페낙 및 베타-사이클로덱스트린 제형 (FORMULATIONS OF LOW DOSE DICLOFENAC AND BETA-CYCLODEXTRIN) ⤷  Try a Trial
Russian Federation 2009118392 ДИКЛОФЕНАКОВЫЙ ГЕЛЬ ⤷  Try a Trial
Australia 2007230716 Formulations of low dose diclofenac and beta-cyclodextrin ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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