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Last Updated: November 29, 2022

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, Akorn, Aleor Dermaceuticals, Amneal Pharms, Aurolife Pharma Llc, Cipla, Encube, Glenmark Pharms Ltd, Padagis Israel, Perrigo Pharma Intl, Taro, Tolmar, Fougera Pharms, Glaxosmithkline Cons, Altaire Pharms Inc, Bausch And Lomb, Falcon Pharms, Rising, Rubicon, Sandoz Inc, Novartis, Javelin Pharms Inc, Amneal, Apotex, Apotex Inc, Cadila, Lupin Ltd, Lupin Pharms, Novel Labs Inc, Pai Holdings Pharm, Twi Pharms, Watson Labs Inc, Horizon, Nuvo Pharms Inc, Actavis Elizabeth, Aurobindo Pharma Usa, Carlsbad, Chartwell Rx, Micro Labs, Pliva, Roxane, Teva, Teva Pharms, Unique Pharm Labs, Dexcel Ltd, Mylan, Riconpharma Llc, Vpna, Pfizer, Actavis Labs Fl Inc, Exela Holdings, Sandoz, and Yung Shin Pharm, and is included in sixty-eight 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 six 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
Cairo UniversityEarly Phase 1
Almirall, S.A.Phase 4
Pakistan Kidney and Liver Institute and Research CenterN/A

See all diclofenac sodium clinical trials

Generic filers with tentative approvals for DICLOFENAC SODIUM
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing1.5% W/WSOLUTION;TOPICAL
See Plans and PricingSee Plans and Pricing2%SOLUTION;TOPICAL
See Plans and PricingSee Plans and Pricing2%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
Micro Labs DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 204355-002 Jul 15, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amneal Pharms DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 203995-002 Nov 25, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Riconpharma Llc DICLOFENAC SODIUM diclofenac sodium TABLET, EXTENDED RELEASE;ORAL 216275-001 Sep 23, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 074390-001 Aug 15, 1996 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Horizon PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma Usa DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 075281-002 Feb 12, 2002 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Novartis VOLTAREN diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 020037-001 Mar 28, 1991 See Plans and Pricing See Plans and Pricing
Falcon Pharms DICLOFENAC SODIUM diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 020809-001 May 4, 1998 See Plans and Pricing See Plans and Pricing
Falcon Pharms DICLOFENAC SODIUM diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 020809-001 May 4, 1998 See Plans and Pricing See Plans and Pricing
Novartis VOLTAREN diclofenac sodium TABLET, DELAYED RELEASE;ORAL 019201-001 Jul 28, 1988 See Plans and Pricing See Plans and Pricing
Fougera Pharms SOLARAZE diclofenac sodium GEL;TOPICAL 021005-001 Oct 16, 2000 See Plans and Pricing See Plans and Pricing
Novartis VOLTAREN diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 020037-001 Mar 28, 1991 See Plans and Pricing See Plans and Pricing
>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 20140038575 FORMULATIONS OF LOW DOSE DICLOFENAC AND BETA-CYCLODEXTRIN See Plans and Pricing
Japan 5823093 See Plans and Pricing
Mexico 2009004038 GEL DE DICLOFENACO. (DICLOFENAC GEL.) See Plans and Pricing
Canada 2647348 FORMULATIONS DE DICLOFENAC ET DE CYCLODEXTRINE BETA A FAIBLEDOSAGE (FORMULATIONS OF LOW DOSE DICLOFENAC AND BETA-CYCLODEXTRIN) See Plans and Pricing
South Korea 20170123724 저 투여량의 디클로페낙 및 베타-사이클로덱스트린 제형 (- FORMULATIONS OF LOW DOSE DICLOFENAC AND BETA-CYCLODEXTRIN) See Plans and Pricing
Australia 2007311019 Diclofenac gel See Plans and Pricing
>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.