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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Accenture
Express Scripts
Deloitte
Healthtrust
Cipla
Fuji
Cantor Fitzgerald
Baxter
Novartis

Generated: December 11, 2017

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Diclofenac potassium - Generic Drug Details

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What are the generic drug 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 Bionpharma Inc, Depomed Inc, Par Form, Novartis, Apotex, Mylan, Sandoz, Sun Pharm Industries, Teva, and Watson Labs Teva, 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-nine 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 Patent Submitted Product Substance Delist Req. Exclusivity Expiration
SandozDICLOFENAC POTASSIUMdiclofenac potassiumTABLET;ORAL075229-001Nov 20, 1998ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
NovartisCATAFLAMdiclofenac potassiumTABLET;ORAL020142-002Nov 24, 1993DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Bionpharma IncDICLOFENAC POTASSIUMdiclofenac potassiumCAPSULE;ORAL204648-001Feb 23, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Depomed IncCAMBIAdiclofenac potassiumFOR SOLUTION;ORAL022165-001Jun 17, 2009ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
ApotexDICLOFENAC POTASSIUMdiclofenac potassiumTABLET;ORAL076561-001Mar 18, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Depomed IncCAMBIAdiclofenac potassiumFOR SOLUTION;ORAL022165-001Jun 17, 2009ABRXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Par FormDICLOFENAC POTASSIUMdiclofenac potassiumFOR SOLUTION;ORAL202964-001May 2, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
MylanDICLOFENAC POTASSIUMdiclofenac potassiumTABLET;ORAL075463-001Jul 26, 1999ABRXNoYes► Subscribe► Subscribe► Subscribe► Subscribe
Depomed IncZIPSORdiclofenac potassiumCAPSULE;ORAL022202-001Jun 16, 2009ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
NovartisCATAFLAMdiclofenac potassiumTABLET;ORAL020142-001Nov 24, 1993DISCNYesNo► Subscribe► 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 IncCAMBIAdiclofenac potassiumFOR SOLUTION;ORAL022165-001Jun 17, 2009► Subscribe► Subscribe
Depomed IncCAMBIAdiclofenac potassiumFOR 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
9,827,197Diclofenac formulations and methods of use► Subscribe
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
South Korea20020050223► Subscribe
European Patent Office3103441► Subscribe
European Patent Office2402003► Subscribe
CroatiaP970269► Subscribe
World Intellectual Property Organization (WIPO)2006133954► Subscribe
Norway20080352► Subscribe
South Africa200710858► Subscribe
Guatemala200600261► Subscribe
Australia733083► Subscribe
World Intellectual Property Organization (WIPO)0113897► 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:

Merck
Daiichi Sankyo
Federal Trade Commission
Deloitte
Cipla
Mallinckrodt
Accenture
Argus Health
Novartis
UBS

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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