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Last Updated: December 5, 2020

DrugPatentWatch Database Preview

Diclofenac epolamine - Generic Drug Details

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What are the generic sources for diclofenac epolamine and what is the scope of patent protection?

Diclofenac epolamine is the generic ingredient in two branded drugs marketed by Inst Biochem and Ibsa Inst Bio, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for diclofenac epolamine

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Recent Clinical Trials for diclofenac epolamine

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SponsorPhase
Food and Drug Administration (FDA)Early Phase 1
University of MarylandEarly Phase 1
IBSA Institut Biochimique SAPhase 4

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Pharmacology for diclofenac epolamine
Paragraph IV (Patent) Challenges for DICLOFENAC EPOLAMINE
Tradename Dosage Ingredient NDA Submissiondate
FLECTOR SYSTEM;TOPICAL diclofenac epolamine 021234 2015-06-26

US Patents and Regulatory Information for diclofenac epolamine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ibsa Inst Bio LICART diclofenac epolamine SYSTEM;TOPICAL 206976-001 Dec 19, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Inst Biochem FLECTOR diclofenac epolamine SYSTEM;TOPICAL 021234-001 Jan 31, 2007 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 epolamine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Inst Biochem FLECTOR diclofenac epolamine SYSTEM;TOPICAL 021234-001 Jan 31, 2007   Start Trial   Start Trial
Inst Biochem FLECTOR diclofenac epolamine SYSTEM;TOPICAL 021234-001 Jan 31, 2007   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:

Dow
Colorcon
Johnson and Johnson
McKesson
AstraZeneca
Mallinckrodt

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