Efinaconazole - Generic Drug Details

What are the generic drug sources for efinaconazole and what is the scope of patent protection?

Efinaconazole is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Lupin Ltd, Nivagen Pharms Inc, Padagis Us, Teva Pharms Usa, Zydus, and Bausch, and is included in seven NDAs. There are eighteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Efinaconazole has eighty-four patent family members in twenty-four countries.

There are fourteen drug master file entries for efinaconazole. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for efinaconazole

International Patents:	84
US Patents:	18
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	5
Patent Applications:	54
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for efinaconazole
What excipients (inactive ingredients) are in efinaconazole?	efinaconazole excipients list
DailyMed Link:	efinaconazole at DailyMed

Recent Clinical Trials for efinaconazole

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

Sponsor	Phase
Dong-A ST Co., Ltd.	Phase 4
Western University of Health Sciences	Phase 3
Bausch Health Americas, Inc.	Phase 4

See all efinaconazole clinical trials

Generic filers with tentative approvals for EFINACONAZOLE

Applicant	Application No.	Strength	Dosage Form
		10%	SOLUTION;TOPICAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for efinaconazole

Drug Class

Azole Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for efinaconazole

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

Paragraph IV (Patent) Challenges for EFINACONAZOLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JUBLIA	Topical Solution	efinaconazole	10%	203567	19	2018-06-06

US Patents and Regulatory Information for efinaconazole

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			Y
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
Zydus	EFINACONAZOLE	efinaconazole	SOLUTION;TOPICAL	212178-001	Jul 15, 2022		DISCN	No	No
Padagis Us	EFINACONAZOLE	efinaconazole	SOLUTION;TOPICAL	211851-001	Dec 16, 2020		DISCN	No	No
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

International Patents for efinaconazole

Country	Patent Number	Title	Estimated Expiration
Argentina	070083	COMPOSICIONES Y METODOS PARA TRATAR ENFERMEDADES DE LA UNA
Denmark	1205559
Brazil	PI0822162	Método para tratamento de doenças das unhas ou leito ungueal e composição farmacêutica para tratamento tópico de doença das unhas ou leito ungueal.
Japan	2010004893	METHOD FOR DETECTING PATHOGENIC MICROORGANISM AND ANTIMICROBIAL AGENT, METHOD FOR EVALUATING EFFECT OF ANTIMICROBIAL AGENT, AND ANTIMICROBIAL AGENT
European Patent Office	1205559	METHODE DE DETECTION DES MICRO-ORGANISMES PATHOGENES ET DES AGENTS ANTIMICROBIENS, METHODE D'EVALUATION DE L'EFFET MEDICAMENTEUX DES AGENTS ANTIMICROBIENS, ET AGENTS ANTIMICROBIENS (METHOD FOR DETECTING PATHOGENIC MICROORGANISMS AND ANTIMICROBIAL AGENTS, METHOD FOR EVALUATING THE DRUG EFFECT OF ANTIMICROBIAL AGENTS, AND ANTIMICROBIAL AGENTS)
China	105848719	抗感染的方法、组合物和装置 (Anti-infective methods, compositions, and devices)
Canada	2391274	METHODE DE DETECTION DE MICROORGANISME PATHOGENE ET D'AGENT ANTIMICROBIEN, METHODE D'EVALUATION DE L'EFFET DE L'AGENT ANTIMICROBIEN, ET AGENT ANTIMICROBIEN (METHOD FOR DETECTING PATHOGENIC MICROORGANISM AND ANTIMICROBIAL AGENT, METHOD FOR EVALUATING EFFECT OF ANTIMICROBIAL AGENT, AND ANTIMICROBIAL AGENT)