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Last Updated: December 1, 2021

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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 patent protection?

Diclofenac potassium is the generic ingredient in four branded drugs marketed by Bionpharma Inc, Strides Pharma, Assertio, Par Form, Amici, Novartis, Rk Pharma, Rubicon, Sandoz, Sun Pharm Industries, Teva, and Watson Labs Teva, and is included in thirteen NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Diclofenac potassium has thirty-three patent family members in twenty-three countries.

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

Drug Prices for diclofenac potassium

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Recent Clinical Trials for diclofenac potassium

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Fayoum University HospitalPhase 4
Cairo UniversityN/A
Gesellschaft für Therapieforschung mbHPhase 3

See all diclofenac potassium clinical trials

Pharmacology for diclofenac potassium
Paragraph IV (Patent) Challenges for DICLOFENAC POTASSIUM
Tradename Dosage Ingredient NDA Submissiondate
ZIPSOR CAPSULE;ORAL diclofenac potassium 022202 2012-11-14
CAMBIA FOR SOLUTION;ORAL diclofenac potassium 022165 2011-01-24

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
Amici CATAFLAM diclofenac potassium TABLET;ORAL 076561-001 Mar 18, 2004 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Par Form DICLOFENAC POTASSIUM diclofenac potassium FOR SOLUTION;ORAL 202964-001 May 2, 2016 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Novartis CATAFLAM diclofenac potassium TABLET;ORAL 020142-002 Nov 24, 1993 DISCN Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Assertio CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165-001 Jun 17, 2009 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Rubicon DICLOFENAC POTASSIUM diclofenac potassium TABLET;ORAL 075229-002 Sep 16, 2021 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Novartis CATAFLAM diclofenac potassium TABLET;ORAL 020142-001 Nov 24, 1993 DISCN Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for diclofenac potassium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Assertio ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 ⤷  Try it Free ⤷  Try it Free
Assertio CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165-001 Jun 17, 2009 ⤷  Try it Free ⤷  Try it Free
Assertio CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165-001 Jun 17, 2009 ⤷  Try it Free ⤷  Try it Free
Assertio ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
Medtronic
AstraZeneca
Johnson and Johnson
Harvard Business School

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 verification 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.