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Last Updated: January 23, 2020

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FLECTOR Drug Profile

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Which patents cover Flector, and when can generic versions of Flector launch?

Flector is a drug marketed by Inst Biochem and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has ten patent family members in nine countries.

The generic ingredient in FLECTOR is diclofenac epolamine. There are forty-seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the diclofenac epolamine profile page.

US ANDA Litigation and Generic Entry Outlook for Flector

Flector was eligible for patent challenges on December 31, 1968.

Annual sales in 2017 were $39mm indicating the motivation for generic entry (peak sales were $278mm in 2012).

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for FLECTOR
Drug Prices for FLECTOR

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Drug Sales Revenue Trends for FLECTOR

See drug sales revenues for FLECTOR

Recent Clinical Trials for FLECTOR

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

SponsorPhase
IBSA Institut Biochimique SAPhase 4
Actavis Inc.Phase 3
PfizerPhase 4

See all FLECTOR clinical trials

Recent Litigation for FLECTOR

Identify potential future generic entrants

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

See all FLECTOR litigation

Pharmacology for FLECTOR
Synonyms for FLECTOR
2-((2,6-Dichlorophenyl)amino)benzeneacetic acid, compd. with 1-pyrrolidineethanol (1:1)
2-(pyrrolidin-1-yl)ethan-1-ol 2-(2-((2,6-dichlorophenyl)amino)phenyl)acetate
2-[2-(2,6-dichloroanilino)phenyl]acetic acid; 2-pyrrolidin-1-ylethanol
2-[2-(2,6-dichloroanilino)phenyl]acetic acid;2-pyrrolidin-1-ylethanol
528D502
AC1L3FWH
Aclonac, Cataflam, Voltaren
Benzeneacetic acid, 2-((2,6-dichlorophenyl)amino)-, compd. with 1-pyrrolidineethanol (1:1)
CHEBI:48296
CHEMBL1201180
D07818
DHEP plaster
Diclofenac acid N-(2-hydroxyetheyl) pyrrolidine salt
Diclofenac-N-(2-hydroxyethyl) pyrrolidine
DIEP
DTXSID80152531
Flector (TN)
LS-186916
N-(2-Hydroxyethyl)pyrrolidinium (2-((2,6-dichlorophenyl)amino)phenyl)acetate
SCHEMBL1006944
UNII-X5F8EKL9ZG
X5F8EKL9ZG
Paragraph IV (Patent) Challenges for FLECTOR
Tradename Dosage Ingredient NDA Submissiondate
FLECTOR PATCH;TOPICAL diclofenac epolamine 021234 2015-06-26

US Patents and Regulatory Information for FLECTOR

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
>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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Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
Merck
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Johnson and Johnson
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