EFINACONAZOLE - Generic Drug Details

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What are the generic drug 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, Padagis Us, Teva Pharms Usa, Umedica, Zydus Lifesciences, 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-five 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:	85
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:	545
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
⤷ Sign Up	⤷ Sign Up	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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch	JUBLIA	efinaconazole	SOLUTION;TOPICAL	203567-001	Jun 6, 2014	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Umedica	EFINACONAZOLE	efinaconazole	SOLUTION;TOPICAL	211969-001	Jun 21, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for EFINACONAZOLE

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	3052487	COMPOSITIONS D'ÉFINACONAZOLE STABILISÉE (STABILIZED EFINACONAZOLE COMPOSITIONS)	⤷ Sign Up
Poland	2730310		⤷ Sign Up
South Korea	102612453		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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