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Last Updated: January 16, 2021

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EFINACONAZOLE - Generic Drug Details

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What are the generic drug sources for efinaconazole and what is the scope of patent protection?

Efinaconazole is the generic ingredient in one branded drug marketed by Bausch and is included in one NDA. There are twelve patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Efinaconazole has sixty-six patent family members in twenty-three countries.

There are fourteen drug master file entries for efinaconazole.

Recent Clinical Trials for EFINACONAZOLE

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

SponsorPhase
Dong-A ST Co., Ltd.Phase 4
Western University of Health SciencesPhase 3
Valeant Pharmaceuticals International, Inc.Phase 4

See all EFINACONAZOLE clinical trials

Paragraph IV (Patent) Challenges for EFINACONAZOLE
Tradename Dosage Ingredient NDA Submissiondate
JUBLIA SOLUTION;TOPICAL efinaconazole 203567 2018-06-06

US Patents and Regulatory Information for EFINACONAZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch JUBLIA efinaconazole SOLUTION;TOPICAL 203567-001 Jun 6, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bausch JUBLIA efinaconazole SOLUTION;TOPICAL 203567-001 Jun 6, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Bausch JUBLIA efinaconazole SOLUTION;TOPICAL 203567-001 Jun 6, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bausch JUBLIA efinaconazole SOLUTION;TOPICAL 203567-001 Jun 6, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bausch JUBLIA efinaconazole SOLUTION;TOPICAL 203567-001 Jun 6, 2014 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

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
Express Scripts
Colorcon
Harvard Business School
Medtronic

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