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Last Updated: November 21, 2024

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 Aurobindo Pharma Ltd, Bionpharma, Strides Pharma, Assertio, Alkem Labs Ltd, Annora Pharma, Endo Operations, Taro, Amici, Novartis, Chartwell Rx, Novast Labs, Rk Pharma, Rubicon, Senores Pharms, Sun Pharm Industries, Teva, Umedica, and Watson Labs Teva, and is included in twenty 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. Forty-two 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

See all DICLOFENAC POTASSIUM clinical trials

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
Assertio ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Assertio ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Assertio ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Assertio ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bionpharma DICLOFENAC POTASSIUM diclofenac potassium CAPSULE;ORAL 204648-001 Feb 23, 2016 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Assertio ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 ⤷  Sign Up ⤷  Sign Up
Assertio ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 ⤷  Sign Up ⤷  Sign Up
Assertio CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165-001 Jun 17, 2009 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for DICLOFENAC POTASSIUM

Country Patent Number Title Estimated Expiration
China 104856959 Diclofenac formulations and methods of use ⤷  Sign Up
South Africa 200710858 Diclofenac formulations and methods of use ⤷  Sign Up
China 101272768 Diclofenac formulations and methods of use ⤷  Sign Up
Australia 2006257072 Diclofenac formulations and methods of use ⤷  Sign Up
Spain 2641889 ⤷  Sign Up
>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.