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Serving leading biopharmaceutical companies globally:

Novartis
Argus Health
QuintilesIMS
Covington
Daiichi Sankyo
AstraZeneca
McKesson
Boehringer Ingelheim
Deloitte
Farmers Insurance

Generated: October 23, 2017

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Diclofenac - Generic Drug Details

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What are the generic sources for diclofenac and what is the scope of diclofenac freedom to operate?

Diclofenac
is the generic ingredient in fourteen branded drugs marketed by Iroko Pharms Llc, Inst Biochem, Depomed Inc, Teva, Sandoz, Novartis, Bionpharma Inc, Watson Labs Teva, Apotex, Mylan, Par Form, Sun Pharm Inds, Apotex Inc, Glenmark Pharms Ltd, Dexcel Ltd, Fougera Pharms, Falcon Pharms, Actavis Elizabeth, Riconpharma Llc, Amneal Pharms, Taro, Glaxosmithkline Cons, Horizon Pharma, Sandoz Inc, Lupin Ltd, Pliva, Tolmar, Actavis Labs Ut Inc, Akorn, Nuvo Pharms Inc, Watson Labs Inc, Rising Pharms Inc, Teva Pharms, Unique Pharm Labs, Teligent Pharma Inc, Novel Labs Inc, Mylan Pharms Inc, Altaire Pharms Inc, Carlsbad, Allied Pharma Inc, Roxane, Bausch And Lomb, Vpna, Actavis Mid Atlantic, Anda Repository, Javelin Pharms Inc, Gd Searle Llc, Exela Holdings, and Actavis Labs Fl Inc, and is included in sixty-six NDAs. There are forty-two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Diclofenac has thirty-nine patent family members in twenty-two countries.

There are forty-seven drug master file entries for diclofenac. One supplier is listed for this compound. There are four tentative approvals for this compound.

Summary for Generic Name: diclofenac

US Patents:42
Tradenames:14
Applicants:49
NDAs:66
Drug Master File Entries: see list47
Suppliers / Packagers: see list1
Bulk Api Vendors: see list62
Clinical Trials: see list293
Patent Applications: see list6,175
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:diclofenac at DailyMed

Pharmacology for Ingredient: diclofenac

Tentative approvals for DICLOFENAC

Applicant Application No. Strength Dosage Form
u► Subscribe2%SOLUTION;TOPICAL
u► Subscribe2%SOLUTION;TOPICAL
u► 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
Par Form
DICLOFENAC POTASSIUM
diclofenac potassium
FOR SOLUTION;ORAL202964-001May 2, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Depomed Inc
ZIPSOR
diclofenac potassium
CAPSULE;ORAL022202-001Jun 16, 2009ABRXYesYes► Subscribe► Subscribe ► Subscribe
Actavis Labs Fl Inc
DICLOFENAC SODIUM AND MISOPROSTOL
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL201089-002Jul 9, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Akorn
DICLOFENAC SODIUM
diclofenac sodium
SOLUTION/DROPS;OPHTHALMIC077845-001Apr 17, 2008ATRXNoNo► Subscribe► Subscribe► Subscribe
Depomed Inc
ZIPSOR
diclofenac potassium
CAPSULE;ORAL022202-001Jun 16, 2009ABRXYesYes► Subscribe► Subscribe ► Subscribe
Iroko Pharms Llc
ZORVOLEX
diclofenac
CAPSULE;ORAL204592-001Oct 18, 2013RXYesNo► Subscribe► SubscribeY ► Subscribe
Allied Pharma Inc
DICLOFENAC SODIUM
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL074986-002Feb 26, 1999DISCNNoNo► Subscribe► Subscribe► Subscribe
Apotex Inc
DICLOFENAC SODIUM
diclofenac sodium
SOLUTION;TOPICAL202027-001May 27, 2014ATRXNoYes► Subscribe► Subscribe► Subscribe
Iroko Pharms Llc
ZORVOLEX
diclofenac
CAPSULE;ORAL204592-001Oct 18, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Roxane
DICLOFENAC SODIUM
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL074391-001Jun 29, 1995DISCNNoNo► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: diclofenac

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
8,735,450Formulation of diclofenac► 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

Country Document Number Estimated Expiration
Mexico347290► Subscribe
Singapore10201401700X► Subscribe
Japan6154846► Subscribe
South Korea20140124873► Subscribe
Canada2759123► Subscribe
Singapore175314► Subscribe
New Zealand620887► Subscribe
South Africa201108650► Subscribe
Japan2015157851► Subscribe
Ukraine106232► 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 leading biopharmaceutical companies globally:

Mallinckrodt
Covington
Citi
Fuji
Chubb
Moodys
Harvard Business School
Julphar
Medtronic
US Department of Justice

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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