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Last Updated: September 28, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203567

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NDA 203567 describes JUBLIA, which is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug and one Paragraph IV challenge. Additional details are available on the JUBLIA profile page.

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.
Summary for 203567
Tradename:JUBLIA
Applicant:Bausch
Ingredient:efinaconazole
Patents:12
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 203567
Generic Entry Date for 203567*:
Constraining patent/regulatory exclusivity:
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.

Pharmacology for NDA: 203567
Suppliers and Packaging for NDA: 203567
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
JUBLIA efinaconazole SOLUTION;TOPICAL 203567 NDA Bausch Health US LLC 0187-5400 0187-5400-02 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-02) > 2 mL in 1 BOTTLE, WITH APPLICATOR
JUBLIA efinaconazole SOLUTION;TOPICAL 203567 NDA Bausch Health US LLC 0187-5400 0187-5400-04 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-04) > 4 mL in 1 BOTTLE, WITH APPLICATOR
Paragraph IV (Patent) Challenges for 203567
Tradename Dosage Ingredient NDA Submissiondate
JUBLIA SOLUTION;TOPICAL efinaconazole 203567 2018-06-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength10%
Approval Date:Jun 6, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 27, 2023
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:  Start TrialPatent Expiration:Jul 8, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Oct 2, 2034Product Flag?YSubstance Flag?Delist Request?
Patented Use:ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS; TOPICAL TREATMENT OF THE TOENAIL(S) DUE TO TRICHOPHYTON RUBRUM AND TRICHOPHYTON MENTAGROPHYTES

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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim
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AstraZeneca
Harvard Business School
Dow

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