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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Queensland Health
Colorcon
Healthtrust
Citi
McKesson
Chinese Patent Office
Accenture
Medtronic

Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203567

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NDA 203567 describes JUBLIA, which is a drug marketed by Dow Pharm and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. 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:Dow Pharm
Ingredient:efinaconazole
Patents:8
Formulation / Manufacturing:see details
Pharmacology for NDA: 203567
Ingredient-typeAzoles
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 Valeant Pharmaceuticals North America LLC 0187-5400 N 0187-5400-02
JUBLIA efinaconazole SOLUTION;TOPICAL 203567 NDA Valeant Pharmaceuticals North America LLC 0187-5400 N 0187-5400-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength10%
Approval Date:Jun 6, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 6, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Sign UpPatent Expiration:Oct 5, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS
Patent:➤ Sign UpPatent Expiration:Jul 8, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Chinese Patent Office
Julphar
AstraZeneca
Daiichi Sankyo
UBS
Harvard Business School
Chubb
Cipla

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