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Last Updated: October 29, 2020

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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 Bionpharma Inc, Strides Pharma, Assertio, Par Form, Novartis, Amici, Mylan, 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-two patent family members in twenty-three countries.

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

Drug Prices for diclofenac potassium

See drug prices for diclofenac potassium

Recent Clinical Trials for diclofenac potassium

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

SponsorPhase
Aswan University HospitalN/A
Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, GermanyPhase 1
Cairo UniversityPhase 4

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
Assertio ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis CATAFLAM diclofenac potassium TABLET;ORAL 020142-002 Nov 24, 1993 DISCN Yes No   Start Trial   Start Trial   Start Trial
Assertio ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Teva DICLOFENAC POTASSIUM diclofenac potassium TABLET;ORAL 075219-001 Aug 6, 1998 AB RX No No   Start Trial   Start Trial   Start Trial
Assertio CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165-001 Jun 17, 2009 AB RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Strides Pharma DICLOFENAC POTASSIUM diclofenac potassium CAPSULE;ORAL 210078-001 Dec 3, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Assertio ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 AB RX Yes Yes   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Assertio CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165-001 Jun 17, 2009   Start Trial   Start Trial
Assertio ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009   Start Trial   Start Trial
Assertio CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165-001 Jun 17, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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.