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Last Updated: July 2, 2022

Diclofenac sodium - Generic Drug Details


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What are the generic 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, Akorn, 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, Apotex, Apotex Inc, Cadila, Lupin Ltd, 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, Vpna, Pfizer, Actavis Labs Fl Inc, Exela Holdings, Sandoz, and Yung Shin Pharm, and is included in sixty-three 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 five suppliers are listed for this compound. There are six 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
Dow University of Health SciencesEarly Phase 1
Azienda Ospedaliera Città della Salute e della Scienza di TorinoPhase 4
Noven Pharmaceuticals, Inc.Phase 1

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
Altaire Pharms Inc DICLOFENAC SODIUM diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 203383-001 Nov 16, 2015 AT RX 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
Pai Holdings Pharm DICLOFENAC SODIUM diclofenac sodium SOLUTION;TOPICAL 202769-001 Jul 8, 2015 AT RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Rising DICLOFENAC SODIUM diclofenac sodium SOLUTION;TOPICAL 206715-001 Aug 7, 2017 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Unique Pharm Labs DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 090066-002 Dec 1, 2010 AB RX No Yes 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
>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 TABLET, DELAYED RELEASE;ORAL 019201-002 Jul 28, 1988 See Plans and Pricing See Plans and Pricing
Novartis VOLTAREN diclofenac sodium TABLET, DELAYED RELEASE;ORAL 019201-003 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
Fougera Pharms SOLARAZE diclofenac sodium GEL;TOPICAL 021005-001 Oct 16, 2000 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for diclofenac sodium

Country Patent Number Title Estimated Expiration
Israel 198161 ג'ל דיכלופני (Diclofenac gel) See Plans and Pricing
European Patent Office 2522343 Formulations de faible dose du diclofénac et de beta-cyclodextrine (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
Japan 5823093 See Plans and Pricing
South Korea 20140038575 FORMULATIONS OF LOW DOSE DICLOFENAC AND BETA-CYCLODEXTRIN See Plans and Pricing
New Zealand 577020 DICLOFENAC GEL CONTAINING DIMETHYL SULFOXIDE (DMSO) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Boehringer Ingelheim
McKesson
Express Scripts
Dow
Merck

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