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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
US Department of Justice
Dow
Express Scripts
Teva
Farmers Insurance
Federal Trade Commission
QuintilesIMS
US Army
Medtronic

Generated: July 22, 2017

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Diclofenac sodium - Generic Drug Details

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What are the generic drug 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 Apotex Inc, Glenmark Pharms Ltd, Novartis, Dexcel Ltd, Fougera Pharms, Falcon Pharms, Actavis Elizabeth, Amneal Pharms, Taro, Glaxosmithkline Cons, Horizon Pharma, Teva, Sandoz Inc, Lupin Ltd, Pliva, Tolmar, Actavis Labs Ut Inc, Akorn, Nuvo Pharms Inc, Watson Labs Inc, Mylan, Rising Pharms Inc, Teva Pharms, Unique Pharm Labs, Teligent Pharma Inc, Sandoz, Novel Labs Inc, Mylan Pharms Inc, Altaire Pharms Inc, Carlsbad, Allied Pharma Inc, Roxane, Bausch And Lomb, Vpna, Actavis Mid Atlantic, Twi Pharms Inc, Javelin Pharms Inc, Gd Searle Llc, Exela Holdings, and Actavis Labs Fl Inc, and is included in fifty-one NDAs. There are twenty-two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Diclofenac sodium has thirty-eight patent family members in fifteen countries.

There are forty-seven drug master file entries for diclofenac sodium. Eighty-two suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for Generic Name: diclofenac sodium

Tradenames:8
Patents:22
Applicants:40
NDAs:51
Drug Master File Entries: see list47
Suppliers / Packagers: see list82
Bulk Api Vendors: see list70
Clinical Trials: see list2,538
Patent Applications: see list6,470
Therapeutic Class:Ophthalmic Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:diclofenac sodium at DailyMed

Tentative approvals for DICLOFENAC SODIUM

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe2%SOLUTION;TOPICAL
► Subscribe► Subscribe2%SOLUTION;TOPICAL
► Subscribe► Subscribe2%SOLUTION;TOPICAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Falcon Pharms
DICLOFENAC SODIUM
diclofenac sodium
SOLUTION/DROPS;OPHTHALMIC020809-001May 4, 1998DISCNNoNo► Subscribe► Subscribe
Nuvo Pharms Inc
PENNSAID
diclofenac sodium
SOLUTION;TOPICAL020947-001Nov 4, 2009DISCNYesNo8,618,164► Subscribe ► Subscribe
Sandoz
DICLOFENAC SODIUM
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL074394-001Nov 30, 1995ABRXNoYes► Subscribe► Subscribe
Novartis
VOLTAREN
diclofenac sodium
SOLUTION/DROPS;OPHTHALMIC020037-001Mar 28, 1991ATRXYesYes► Subscribe► Subscribe
Unique Pharm Labs
DICLOFENAC SODIUM
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL090066-002Dec 1, 2010ABRXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: diclofenac sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
VOLTAREN
diclofenac sodium
SOLUTION/DROPS;OPHTHALMIC020037-001Mar 28, 19913,652,762► Subscribe
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 20005,792,753► Subscribe
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 20005,852,002► Subscribe
Novartis
VOLTAREN
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL019201-001Jul 28, 19883,652,762► Subscribe
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 20005,914,322► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
8,580,954Formulations of low dose diclofenac and beta-cyclodextrin► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: diclofenac sodium

Country Document Number Estimated Expiration
China104606126► Subscribe
European Patent Office2522344► Subscribe
BrazilPI0709409► Subscribe
European Patent Office2004203► Subscribe
South Korea20150050595► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Argus Health
McKesson
Chubb
Medtronic
Merck
QuintilesIMS
Citi
Teva
Cantor Fitzgerald
Deloitte

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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