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Serving leading biopharmaceutical companies globally:

Fuji
Novartis
Argus Health
Dow
Daiichi Sankyo
Mallinckrodt
Julphar
US Department of Justice
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Express Scripts

Generated: November 18, 2017

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DICLOFENAC POTASSIUM - Generic Drug Details

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

Diclofenac potassium
is the generic ingredient in four branded drugs marketed by Depomed Inc, Teva, Sandoz, Novartis, Bionpharma Inc, Watson Labs Teva, Apotex, Mylan, Par Form, and Sun Pharm Inds, and is included in twelve NDAs. There are thirteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Diclofenac potassium has eighty-eight patent family members in thirty-six countries.

There are forty-seven drug master file entries for diclofenac potassium. Twenty-two suppliers are listed for this compound.

Pharmacology for DICLOFENAC POTASSIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Depomed Inc
CAMBIA
diclofenac potassium
FOR SOLUTION;ORAL022165-001Jun 17, 2009ABRXYesYes► Subscribe► Subscribe ► Subscribe
Depomed Inc
CAMBIA
diclofenac potassium
FOR SOLUTION;ORAL022165-001Jun 17, 2009ABRXYesYes► Subscribe► Subscribe ► Subscribe
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
Depomed Inc
ZIPSOR
diclofenac potassium
CAPSULE;ORAL022202-001Jun 16, 2009ABRXYesYes► Subscribe► Subscribe ► Subscribe
Depomed Inc
ZIPSOR
diclofenac potassium
CAPSULE;ORAL022202-001Jun 16, 2009ABRXYesYes► Subscribe► Subscribe ► Subscribe
Sun Pharm Inds
DICLOFENAC POTASSIUM
diclofenac potassium
TABLET;ORAL075470-001Feb 21, 2002DISCNNoNo► Subscribe► Subscribe► Subscribe
Depomed Inc
ZIPSOR
diclofenac potassium
CAPSULE;ORAL022202-001Jun 16, 2009ABRXYesYes► Subscribe► Subscribe ► Subscribe
Teva
DICLOFENAC POTASSIUM
diclofenac potassium
TABLET;ORAL075219-001Aug 6, 1998ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex
DICLOFENAC POTASSIUM
diclofenac potassium
TABLET;ORAL076561-001Mar 18, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: diclofenac potassium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Depomed Inc
CAMBIA
diclofenac potassium
FOR SOLUTION;ORAL022165-001Jun 17, 2009► Subscribe► Subscribe
Depomed Inc
CAMBIA
diclofenac potassium
FOR SOLUTION;ORAL022165-001Jun 17, 2009► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: diclofenac potassium

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
7,687,542Rapidly bioavailable tablet and capsule formulations 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 potassium

Country Document Number Estimated Expiration
Poland329919► Subscribe
Japan2002509103► Subscribe
Norway20003698► Subscribe
European Patent Office1159960► Subscribe
CroatiaP20020045► Subscribe
Canada2632375► Subscribe
New Zealand332655► Subscribe
Slovakia157698► Subscribe
Slovenia20849► Subscribe
Australia2117399► 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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Serving leading biopharmaceutical companies globally:

Julphar
AstraZeneca
Colorcon
Queensland Health
Fish and Richardson
UBS
Baxter
Fuji
McKesson
Teva

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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