Efinaconazole - Generic Drug Details

What are the generic sources for efinaconazole and what is the scope of freedom to operate?

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 sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Efinaconazole has eighty 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:	80
US Patents:	16
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	5
Patent Applications:	48
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
Valeant Pharmaceuticals International, 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

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
Zydus	EFINACONAZOLE	efinaconazole	SOLUTION;TOPICAL	212178-001	Jul 15, 2022	AB	RX	No	No
Lupin Ltd	EFINACONAZOLE	efinaconazole	SOLUTION;TOPICAL	212169-001	Mar 2, 2022		DISCN	No	No
Bausch	JUBLIA	efinaconazole	SOLUTION;TOPICAL	203567-001	Jun 6, 2014	AB	RX	Yes	Yes
Nivagen Pharms Inc	EFINACONAZOLE	efinaconazole	SOLUTION;TOPICAL	211969-001	Jun 21, 2021	AB	RX	No	No
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 efinaconazole

Country	Patent Number	Title	Estimated Expiration
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.
Canada	3052643	PROCEDES, COMPOSITIONS ET DISPOSITIFS ANTI-INFECTIEUX (ANTI-INFECTIVE METHODS, COMPOSITIONS, AND DEVICES)
Japan	6774518
Austria	434667
Canada	2706114	COMPOSITIONS ET PROCEDES DE TRAITEMENT DES MALADIES DE L'ONGLE (COMPOSITIONS AND METHODS FOR TREATING DISEASES OF THE NAIL)
Australia	5852400
Portugal	1205559