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Last Updated: November 26, 2020

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JUBLIA Drug 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 twelve patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-four patent family members in twenty-three 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.

US ANDA Litigation and Generic Entry Outlook for Jublia

Jublia was eligible for patent challenges on June 6, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 24, 2030. This may change due to patent challenges or generic licensing.

There have been eighteen patent litigation cases 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.

There is one tentative approval for the generic drug (efinaconazole), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for JUBLIA
Drug Prices for JUBLIA

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Generic Entry Opportunity Date for JUBLIA
Generic Entry Date for JUBLIA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;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 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 NDA Submissiondate
JUBLIA SOLUTION;TOPICAL efinaconazole 203567 2018-06-06

US Patents and Regulatory Information for JUBLIA

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   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
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   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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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.