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Serving leading biopharmaceutical companies globally:

Harvard Business School
Deloitte
Queensland Health
Julphar
Cantor Fitzgerald
Johnson and Johnson
Farmers Insurance
UBS
Covington
Boehringer Ingelheim

Generated: February 23, 2018

DrugPatentWatch Database Preview

DICLOFENAC SODIUM - Generic Drug Details

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What are the generic sources for diclofenac sodium and what is the scope of diclofenac sodium patent protection?

Diclofenac sodium
is the generic ingredient in eight branded drugs marketed by Actavis Mid Atlantic, Amneal Pharms, Glenmark Pharms Ltd, Taro, Tolmar, Fougera Pharms, Glaxosmithkline Cons, Akorn, Altaire Pharms Inc, Apotex Inc, Bausch And Lomb, Falcon Pharms, Rising Pharms Inc, Sandoz Inc, Novartis, Javelin Pharms Inc, Anda Repository, Lupin Ltd, Novel Labs Inc, Riconpharma Llc, Teligent Pharma Inc, Watson Labs Inc, Horizon Pharma, Nuvo Pharms Inc, Actavis Elizabeth, Allied Pharma Inc, Carlsbad, Mylan Pharms Inc, Pliva, Roxane, Sandoz, Teva, Teva Pharms, Unique Pharm Labs, Dexcel Ltd, Mylan, Vpna, Gd Searle Llc, Actavis Labs Fl Inc, and Exela Holdings, and is included in fifty-one NDAs. There are twenty-one 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. Eighty-eight suppliers are listed for this compound. There are four tentative approvals for this compound.
Tentative approvals for DICLOFENAC SODIUM
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up2%SOLUTION;TOPICAL
➤ Sign Up➤ Sign Up2%SOLUTION;TOPICAL
➤ Sign Up➤ Sign Up2%SOLUTION;TOPICAL

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
Mylan Pharms Inc DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 075281-003 Feb 12, 2002 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Tolmar DICLOFENAC SODIUM diclofenac sodium GEL;TOPICAL 200936-001 Oct 28, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis VOLTAREN diclofenac sodium TABLET, DELAYED RELEASE;ORAL 019201-002 Jul 28, 1988 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Exela Holdings DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 200540-002 Mar 14, 2014 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Horizon Pharma PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Horizon Pharma PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Horizon Pharma PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Allied Pharma Inc DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 074986-002 Feb 26, 1999 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Amneal Pharms DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 203995-001 Nov 25, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Horizon Pharma PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 019201-003 Jul 28, 1988 ➤ Sign Up ➤ Sign Up
Fougera Pharms SOLARAZE diclofenac sodium GEL;TOPICAL 021005-001 Oct 16, 2000 ➤ Sign Up ➤ Sign Up
Fougera Pharms SOLARAZE diclofenac sodium GEL;TOPICAL 021005-001 Oct 16, 2000 ➤ Sign Up ➤ Sign Up
Novartis VOLTAREN diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 020037-001 Mar 28, 1991 ➤ Sign Up ➤ Sign Up
Novartis VOLTAREN diclofenac sodium TABLET, DELAYED RELEASE;ORAL 019201-002 Jul 28, 1988 ➤ Sign Up ➤ Sign Up
Fougera Pharms SOLARAZE diclofenac sodium GEL;TOPICAL 021005-001 Oct 16, 2000 ➤ Sign Up ➤ Sign Up
Falcon Pharms DICLOFENAC SODIUM diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 020809-001 May 4, 1998 ➤ Sign Up ➤ Sign Up
Novartis VOLTAREN diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 020037-001 Mar 28, 1991 ➤ Sign Up ➤ Sign Up
Falcon Pharms DICLOFENAC SODIUM diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 020809-001 May 4, 1998 ➤ Sign Up ➤ Sign Up
Fougera Pharms SOLARAZE diclofenac sodium GEL;TOPICAL 021005-001 Oct 16, 2000 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for DICLOFENAC SODIUM

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,580,954 Formulations of low dose diclofenac and beta-cyclodextrin ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for DICLOFENAC SODIUM

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Argus Health
Cantor Fitzgerald
Cerilliant
Baxter
UBS
US Department of Justice
Fish and Richardson
Accenture

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 verifification 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.

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