JUBLIA Drug Patent Profile

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 eighteen patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-four 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 16^th, 2020.

Summary for JUBLIA

International Patents:	84
US Patents:	18
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	4
Patent Applications:	42
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for JUBLIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JUBLIA
What excipients (inactive ingredients) are in JUBLIA?	JUBLIA excipients list
DailyMed Link:	JUBLIA at DailyMed

See drug prices for JUBLIA

Recent Clinical Trials for JUBLIA

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

Sponsor	Phase
Dong-A ST Co., Ltd.	Phase 4
University of Alabama at Birmingham	Phase 4
University of Alabama at Birmingham	N/A

See all JUBLIA clinical trials

Pharmacology for JUBLIA

Drug Class

Azole Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for JUBLIA

D01AC	Imidazole and triazole derivatives
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

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 eighteen US patents.

Patents protecting 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	AB	RX	Yes	Yes
Bausch	JUBLIA	efinaconazole	SOLUTION;TOPICAL	203567-001	Jun 6, 2014	AB	RX	Yes	Yes			Y
Bausch	JUBLIA	efinaconazole	SOLUTION;TOPICAL	203567-001	Jun 6, 2014	AB	RX	Yes	Yes
Bausch	JUBLIA	efinaconazole	SOLUTION;TOPICAL	203567-001	Jun 6, 2014	AB	RX	Yes	Yes
Bausch	JUBLIA	efinaconazole	SOLUTION;TOPICAL	203567-001	Jun 6, 2014	AB	RX	Yes	Yes
Bausch	JUBLIA	efinaconazole	SOLUTION;TOPICAL	203567-001	Jun 6, 2014	AB	RX	Yes	Yes
Bausch	JUBLIA	efinaconazole	SOLUTION;TOPICAL	203567-001	Jun 6, 2014	AB	RX	Yes	Yes			Y

International Patents for JUBLIA

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

Country	Patent Number	Title	Estimated Expiration
Germany	60042453
Australia	2016277570	Compositions and methods for treating diseases of the nail
Canada	2924748	COMPOSITIONS D'EFINACONAZOLE STABILISEE (STABILIZED EFINACONAZOLE FORMULATIONS)
European Patent Office	2234621	COMPOSITIONS ET PROCÉDÉS DE TRAITEMENT DES MALADIES DE L'ONGLE (COMPOSITIONS AND METHODS FOR TREATING DISEASES OF THE NAIL)
European Patent Office	2853274	COMPOSITIONS ET PROCÉDÉS DE TRAITEMENT DES MALADIES DE L'ONGLE (COMPOSITIONS AND METHODS FOR TREATING DISEASES OF THE NAIL)
China	110433291	稳定的艾菲康唑组合物 (Stabilized efinaconazole compositions)
Mexico	2010007230	COMPOSICIONES Y METODOS PARA TRATAR ENFERMEDADES DE LAS UÑAS. (COMPOSITIONS AND METHODS FOR TREATING DISEASES OF THE NAIL.)