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Last Updated: September 27, 2022

JUBLIA Drug Patent Profile


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When do Jublia patents expire, and what generic alternatives are available?

Jublia is a drug marketed by Bausch and is included in one NDA. There are sixteen patents protecting this drug and one Paragraph IV challenge.

This drug has eighty patent family members in twenty-four countries.

The generic ingredient in JUBLIA is efinaconazole. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the efinaconazole profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Jublia

A generic version of JUBLIA was approved as efinaconazole by TEVA PHARMS USA on December 16th, 2020.

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Drug patent expirations by year for JUBLIA
Drug Prices for JUBLIA

See drug prices for JUBLIA

Recent Clinical Trials for JUBLIA

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

SponsorPhase
Dong-A ST Co., Ltd.Phase 4
University of Alabama at BirminghamPhase 4
University of Alabama at BirminghamN/A

See all JUBLIA clinical trials

Pharmacology for JUBLIA
Paragraph IV (Patent) Challenges for JUBLIA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
JUBLIA Topical Solution efinaconazole 10% 203567 19 2018-06-06

US Patents and Regulatory Information for JUBLIA

JUBLIA is protected by sixteen US patents and one FDA Regulatory Exclusivity.

Patents protecting JUBLIA

Compositions and methods for treating diseases of the nail
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stabilized efinaconazole compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS; TOPICAL TREATMENT OF THE TOENAIL(S) DUE TO TRICHOPHYTON RUBRUM AND TRICHOPHYTON MENTAGROPHYTES

Applicator
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL TREATMENT OF TINEA UNGUIUM BY USING AN APPLICATOR FOR APPLYING A SOLUTION FOR TREATING TINEA UNGUIUM TO AN AFFECTED PART OF A PATIENT

Compositions and methods for treating diseases of the nail
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL TREATMENT OF ONYCHOMYCOSIS OF THE TOENAIL(S) DUE TO TRICHOPHYTON RUBRUM AND TRICHOPHYTON MENTAGROPHYTES

Anti-infective methods, compositions, and devices
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS; TOPICAL TREATMENT OF THE TOENAIL(S) DUE TO TRICHOPHYTON RUBRUM AND TRICHOPHYTON MENTAGROPHYTES

Compositions and methods for treating diseases of the nail
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stabilized efinaconazole formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS; TOPICAL TREATMENT OF THE TOENAIL(S) DUE TO TRICHOPHYTON RUBRUM AND TRICHOPHYTON MENTAGROPHYTES

Compositions and methods for treating diseases of the nail
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS; TOPICAL TREATMENT OF THE TOENAIL(S) DUE TO TRICHOPHYTON RUBRUM AND TRICHOPHYTON MENTAGROPHYTES

Method for treating onychomycosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS

Compositions and methods for treating diseases of the nail
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS

Compositions and methods for treating diseases of the nail
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and methods for treating diseases of the nail
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and methods for treating diseases of the nail
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL TREATMENT OF ONYCHOMYCOSIS OF THE TOENAIL(S) DUE TO TRICHOPHYTON RUBRUM AND TRICHOPHYTON MENTAGROPHYTES

Stabilized efinaconazole compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and methods for treating diseases of the nail
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and methods for treating diseases of the nail
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL TREATMENT OF ONYCHOMYCOSIS OF THE TOENAIL(S) DUE TO TRICHOPHYTON RUBRUM AND TRICHOPHYTON MENTAGROPHYTES

FDA Regulatory Exclusivity protecting JUBLIA

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

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

International Patents for JUBLIA

See the table below for patents covering JUBLIA around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 2112228 See Plans and Pricing
Canada 3052643 PROCEDES, COMPOSITIONS ET DISPOSITIFS ANTI-INFECTIEUX (ANTI-INFECTIVE METHODS, COMPOSITIONS, AND DEVICES) See Plans and Pricing
Malaysia 179756 STABILIZED EFINACONAZOLE FORMULATIONS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
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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.