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Last Updated: September 22, 2020

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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, Amneal Pharms, Cipla, Encube, Glenmark Pharms Ltd, Hi Tech, Mylan, Perrigo Uk Finco, Taro, Tolmar, Fougera Pharms, Glaxosmithkline Cons, Akorn, Altaire Pharms Inc, Bausch And Lomb, Falcon Pharms, Rising, Rubicon, Sandoz Inc, Novartis, Mylan Labs Ltd, Javelin Pharms Inc, Apotex Inc, Cadila, Lupin Ltd, Novel Labs Inc, Riconpharma Llc, Teligent Pharma Inc, Twi Pharms, Watson Labs Inc, Horizon, Nuvo Pharms Inc, Actavis Elizabeth, Carlsbad, Casi Pharms Inc, Micro Labs Usa, Mylan Pharms Inc, Pliva, Roxane, Teva, Teva Pharms, Unique Pharm Labs, Dexcel Ltd, Vpna, Gd Searle Llc, Actavis Labs Fl Inc, Exela Holdings, Sandoz, and Yung Shin Pharm, and is included in sixty 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 forty-seven drug master file entries for diclofenac sodium. Seventy-seven 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
Assiut UniversityN/A
Guang'anmen Hospital of China Academy of Chinese Medical SciencesN/A
William N HandelmanPhase 2

See all DICLOFENAC SODIUM clinical trials

Generic filers with tentative approvals for DICLOFENAC SODIUM
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial1.5% W/WSOLUTION;TOPICAL
  Start Trial  Start Trial2%SOLUTION;TOPICAL
  Start Trial  Start 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 NDA Submissiondate
DYLOJECT SOLUTION;INTRAVENOUS diclofenac sodium 022396 2015-12-15
PENNSAID SOLUTION;TOPICAL diclofenac sodium 204623 2014-06-03
PENNSAID SOLUTION;TOPICAL diclofenac sodium 020947 2012-07-11
SOLARAZE GEL;TOPICAL diclofenac sodium 021005 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 SOLUTION/DROPS;OPHTHALMIC 020037-001 Mar 28, 1991 AT RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis VOLTAREN diclofenac sodium TABLET, DELAYED RELEASE;ORAL 019201-003 Jul 28, 1988 DISCN Yes No   Start Trial   Start Trial   Start Trial
Carlsbad DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 075185-001 Nov 13, 1998 AB RX No No   Start Trial   Start Trial   Start Trial
Exela Holdings DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 200540-002 Mar 14, 2014 DISCN No No   Start Trial   Start Trial   Start Trial
Sandoz Inc DICLOFENAC SODIUM diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 078031-001 Feb 6, 2008 AT RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms DICLOFENAC SODIUM diclofenac sodium GEL;TOPICAL 208077-001 Mar 18, 2016 AB RX No No   Start Trial   Start Trial   Start 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
Novartis VOLTAREN diclofenac sodium TABLET, DELAYED RELEASE;ORAL 019201-002 Jul 28, 1988   Start Trial   Start Trial
Fougera Pharms SOLARAZE diclofenac sodium GEL;TOPICAL 021005-001 Oct 16, 2000   Start Trial   Start Trial
Falcon Pharms DICLOFENAC SODIUM diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 020809-001 May 4, 1998   Start Trial   Start Trial
Novartis VOLTAREN diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 020037-001 Mar 28, 1991   Start Trial   Start Trial
Falcon Pharms DICLOFENAC SODIUM diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 020809-001 May 4, 1998   Start Trial   Start Trial
Fougera Pharms SOLARAZE diclofenac sodium GEL;TOPICAL 021005-001 Oct 16, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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