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Last Updated: January 27, 2023

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 Inc, Strides Pharma, Assertio, Alkem Labs Ltd, Annora Pharma, Par Form, Amici, Novartis, Novast Labs, Rk Pharma, Rubicon, Sandoz, Sun Pharm Industries, Teva, Umedica Labs Pvt Ltd, and Watson Labs Teva, and is included in eighteen 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. Twenty-eight 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
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
Sun Pharm Industries DICLOFENAC POTASSIUM diclofenac potassium TABLET;ORAL 075470-001 Feb 21, 2002 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Assertio CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165-001 Jun 17, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Rubicon DICLOFENAC POTASSIUM diclofenac potassium TABLET;ORAL 075229-002 Sep 16, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Assertio ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bionpharma Inc DICLOFENAC POTASSIUM diclofenac potassium CAPSULE;ORAL 204648-001 Feb 23, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165-001 Jun 17, 2009 See Plans and Pricing See Plans and Pricing
Assertio ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 See Plans and Pricing See Plans and Pricing
Assertio CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165-001 Jun 17, 2009 See Plans and Pricing See Plans and Pricing
Assertio ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for diclofenac potassium

Country Patent Number Title Estimated Expiration
Jordan 3352 صيغ دايكلوفيناك وطرق استخدامه (Diclofenac formulations and methods of use) See Plans and Pricing
New Zealand 564002 Diclofenac formulations and methods of use See Plans and Pricing
Ecuador SP077989 FORMULACIÓN DE DICLOFENAC Y MÉTODOS PARA USARLAS See Plans and Pricing
Spain 2912897 See Plans and Pricing
Australia 2006257072 Diclofenac formulations and methods of use See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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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.