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Serving leading biopharmaceutical companies globally:

Cipla
Covington
Cantor Fitzgerald
McKinsey
Teva
Baxter
US Department of Justice
Citi
Healthtrust
Cerilliant

Generated: January 22, 2018

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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 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.
Summary for DICLOFENAC POTASSIUM
Pharmacology for DICLOFENAC POTASSIUM

US Patents and Regulatory Information 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
Sandoz DICLOFENAC POTASSIUM diclofenac potassium TABLET;ORAL 075229-001 Nov 20, 1998 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Par Form DICLOFENAC POTASSIUM diclofenac potassium FOR SOLUTION;ORAL 202964-001 May 2, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Apotex DICLOFENAC POTASSIUM diclofenac potassium TABLET;ORAL 076561-001 Mar 18, 2004 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Depomed Inc CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165-001 Jun 17, 2009 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Depomed Inc ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Depomed Inc ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva DICLOFENAC POTASSIUM diclofenac potassium TABLET;ORAL 075219-001 Aug 6, 1998 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Depomed Inc CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165-001 Jun 17, 2009 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan DICLOFENAC POTASSIUM diclofenac potassium TABLET;ORAL 075463-001 Jul 26, 1999 AB RX No Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Depomed Inc ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
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 POTASSIUM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Depomed Inc CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165-001 Jun 17, 2009 ➤ Subscribe ➤ Subscribe
Depomed Inc CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165-001 Jun 17, 2009 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
9,827,197 Diclofenac formulations and methods of use ➤ Subscribe
7,687,542 Rapidly bioavailable tablet and capsule formulations of diclofenac ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for DICLOFENAC POTASSIUM

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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Moodys
Covington
Healthtrust
Merck
Novartis
US Department of Justice
Colorcon
Cerilliant

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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