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Last Updated: November 2, 2024

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 Ibsa and Ibsa Inst Bio, and is included in two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for diclofenac epolamine. Seven suppliers are listed for this compound.

Summary for diclofenac epolamine
Drug Prices for diclofenac epolamine

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for diclofenac epolamine
Generic Entry Date for diclofenac epolamine*:
Constraining patent/regulatory exclusivity:
Dosage:
SYSTEM;TOPICAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for diclofenac epolamine

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

SponsorPhase
IBSA Institut Biochimique SAPhase 3
Food and Drug Administration (FDA)Early Phase 1
University of Maryland, BaltimoreEarly Phase 1

See all diclofenac epolamine clinical trials

Pharmacology for diclofenac epolamine
Paragraph IV (Patent) Challenges for DICLOFENAC EPOLAMINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FLECTOR Topical Patch diclofenac epolamine 1.3% 021234 1 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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ibsa Inst Bio LICART diclofenac epolamine SYSTEM;TOPICAL 206976-001 Dec 19, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ibsa FLECTOR diclofenac epolamine SYSTEM;TOPICAL 021234-001 Jan 31, 2007 RX Yes Yes ⤷  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

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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.