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Last Updated: March 18, 2024

Diclofenac potassium - Generic Drug Details


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

Diclofenac potassium is the generic ingredient in four branded drugs marketed by Aurobindo Pharma Ltd, Bionpharma, Strides Pharma, Assertio, Alkem Labs Ltd, Annora Pharma, Par Form, Amici, Novartis, Chartwell Rx, Novast Labs, Rk Pharma, Rubicon, Senores Pharms, Sun Pharm Industries, Teva, Umedica, and Watson Labs Teva, and is included in nineteen 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-four patent family members in twenty-three countries.

There are eleven drug master file entries for diclofenac potassium. Thirty-five suppliers are listed for this compound.

Drug Prices for diclofenac potassium

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Recent Clinical Trials for diclofenac potassium

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SponsorPhase
Danish Headache CenterPhase 4
Fayoum University HospitalPhase 4
Cairo UniversityN/A

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Pharmacology for diclofenac potassium
Paragraph IV (Patent) Challenges for DICLOFENAC POTASSIUM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ZIPSOR Capsules diclofenac potassium 25 mg 022202 1 2012-11-14
CAMBIA Oral Solution (Sachet) diclofenac potassium 50 mg 022165 1 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
Par Form DICLOFENAC POTASSIUM diclofenac potassium FOR SOLUTION;ORAL 202964-001 May 2, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Rx DICLOFENAC POTASSIUM diclofenac potassium TABLET;ORAL 075582-001 Feb 23, 2001 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Assertio CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165-001 Jun 17, 2009 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Assertio CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165-001 Jun 17, 2009 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Assertio ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 a Trial ⤷  Try a Trial
Assertio CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165-001 Jun 17, 2009 ⤷  Try a Trial ⤷  Try a Trial
Assertio CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165-001 Jun 17, 2009 ⤷  Try a Trial ⤷  Try a Trial
Assertio ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for diclofenac potassium

Country Patent Number Title Estimated Expiration
Spain 2641889 ⤷  Try a Trial
China 112755014 双氯芬酸制剂和使用方法 (DICLOFENAC FORMULATIONS AND METHODS OF USE) ⤷  Try a Trial
New Zealand 564002 Diclofenac formulations and methods of use ⤷  Try a Trial
European Patent Office 1890680 PREPARATIONS DE DICLOFENAC ET LEURS METHODES D'UTILISATION (DICLOFENAC FORMULATIONS AND METHODS OF USE) ⤷  Try a Trial
Brazil PI0612245 formulações de diclofenaco e métodos de uso ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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