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Last Updated: November 17, 2019

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Diclofenac epolamine - Generic Drug Details

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What are the generic drug 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. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Diclofenac epolamine has ten patent family members in nine countries.

There are forty-seven drug master file entries for diclofenac epolamine. Eight 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

See all diclofenac epolamine clinical trials

Recent Litigation for diclofenac epolamine

Identify potential future generic entrants

District Court Litigation
Case NameDate
Altergon SA v. Actavis Laboratories UT, Inc.2015-10-01

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Pharmacology for diclofenac epolamine
Paragraph IV (Patent) Challenges for DICLOFENAC EPOLAMINE
Tradename Dosage Ingredient NDA Submissiondate
FLECTOR PATCH;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
Inst Biochem FLECTOR diclofenac epolamine PATCH;TOPICAL 021234-001 Jan 31, 2007 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Ibsa Inst Bio LICART diclofenac epolamine SYSTEM;TOPICAL 206976-001 Dec 19, 2018 DISCN Yes 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 epolamine

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

Baxter
Mallinckrodt
Johnson and Johnson
Colorcon
Medtronic
Dow

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