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Last Updated: March 19, 2024

Diclofenac sodium - Generic Drug Details


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What are the generic 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
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
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
Sandoz DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 200158-001 May 9, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Elizabeth DICLOFENAC SODIUM diclofenac sodium TABLET, EXTENDED RELEASE;ORAL 075910-001 Jan 7, 2002 DISCN 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
Falcon Pharms DICLOFENAC SODIUM diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 020809-001 May 4, 1998 ⤷  Try a Trial ⤷  Try a Trial
Fougera Pharms SOLARAZE diclofenac sodium GEL;TOPICAL 021005-001 Oct 16, 2000 ⤷  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 TABLET, DELAYED RELEASE;ORAL 019201-003 Jul 28, 1988 ⤷  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 20160033796 저 복용량의 디클로페낙 및 베타-사이클로덱스트린 제형 (FORMULATIONS OF LOW DOSE DICLOFENAC AND BETA-CYCLODEXTRIN) ⤷  Try a Trial
Japan 2014005309 FORMULATION OF LOW DOSE DICLOFENAC AND &bgr;-CYCLODEXTRIN ⤷  Try a Trial
Mexico 2008012495 FORMULACIONES DE DOSIS BAJA DE DICLOFENACO Y BETA-CICLODEXTRINA. (FORMULATIONS OF LOW DOSE DICLOFENAC AND BETA-CYCLODEXTRIN.) ⤷  Try a Trial
Japan 2016040327 低投与量のジクロフェナク及びβ−シクロデキストリンの配合物 (FORMULATION OF LOW DOSE DICLOFENAC AND &bgr;-CYCLODEXTRIN) ⤷  Try a Trial
>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.