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Last Updated: November 2, 2024

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, Alembic, Amneal, Amneal Pharms, Aurolife Pharma Llc, Cipla, Encube, Glenmark Pharms Ltd, Hikma, Padagis Israel, Perrigo Pharma Intl, Taro, Fougera Pharms, Haleon Us Holdings, Altaire Pharms Inc, Bausch And Lomb, Falcon Pharms, Rising, Rubicon, Sandoz, Sciegen Pharms Inc, 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-eight 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
Jamia Millia IslamiaN/A
University of RijekaN/A
Fayoum University HospitalN/A

See all diclofenac sodium clinical trials

Generic filers with tentative approvals for DICLOFENAC SODIUM
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up1.5% W/WSOLUTION;TOPICAL
⤷  Sign Up⤷  Sign Up2%SOLUTION;TOPICAL
⤷  Sign Up⤷  Sign Up2%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 diclofenac sodium TABLET, DELAYED RELEASE;ORAL 074986-002 Feb 26, 1999 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Haleon Us Holdings VOLTAREN ARTHRITIS PAIN diclofenac sodium GEL;TOPICAL 022122-001 Oct 17, 2007 OTC Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch And Lomb DICLOFENAC SODIUM diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 078792-001 Dec 28, 2007 AT RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Lupin Pharms DICLOFENAC SODIUM diclofenac sodium SOLUTION;TOPICAL 208021-001 Sep 20, 2022 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Fougera Pharms SOLARAZE diclofenac sodium GEL;TOPICAL 021005-001 Oct 16, 2000 ⤷  Sign Up ⤷  Sign Up
Javelin Pharms Inc DYLOJECT diclofenac sodium SOLUTION;INTRAVENOUS 022396-001 Dec 23, 2014 ⤷  Sign Up ⤷  Sign Up
Fougera Pharms SOLARAZE diclofenac sodium GEL;TOPICAL 021005-001 Oct 16, 2000 ⤷  Sign Up ⤷  Sign Up
Novartis VOLTAREN diclofenac sodium TABLET, DELAYED RELEASE;ORAL 019201-003 Jul 28, 1988 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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.