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Last Updated: December 5, 2020

DrugPatentWatch Database Preview

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, Novartis, Anda Repository, 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

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Recent Clinical Trials for diclofenac potassium

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

SponsorPhase
Cairo UniversityN/A
Gesellschaft für Therapieforschung mbHPhase 3
Infectopharm Arzneimittel GmbHPhase 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
Sandoz DICLOFENAC POTASSIUM diclofenac potassium TABLET;ORAL 075582-001 Feb 23, 2001 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan DICLOFENAC POTASSIUM diclofenac potassium TABLET;ORAL 075463-001 Jul 26, 1999 AB RX No 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
>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 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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Serving leading biopharmaceutical companies globally:

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