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Efinaconazole - Generic Drug Details

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

Efinaconazole is the generic ingredient in one branded drug marketed by Bausch and is included in one NDA. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Efinaconazole has forty-seven patent family members in twenty-one countries.

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

Summary for efinaconazole

International Patents:	47
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	14
Suppliers / Packagers:	1
Bulk Api Vendors:	35
Clinical Trials:	4
Patent Applications:	34
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for efinaconazole
DailyMed Link:	efinaconazole at DailyMed

Pharmacology for efinaconazole

Drug Class

Azole Antifungal

Synonyms for efinaconazole

(2R, 3R)-2-(2,4-Difluorophenyl)-3-(4-methylenepiperidyl)-1-(1,2,4-triazolyl)butan-2-ol

(2R,3R)-2-(2,4-Difluorofenil)-3-(4-metilenopiperidin-1-il)-1-(1H-1,2,4-triazin-1-il)butan-2-ol

(2R,3R)-2-(2,4-Difluorophenyl)-3-(4-methylene-1-piperidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol

(2R,3R)-2-(2,4-difluorophenyl)-3-(4-methylene-1-piperidyl)-1-(1,2,4-triazol-1-yl)butan-2-ol

(2R,3R)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidin-1-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol

(2R,3R)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidine-1-yl)-1-(1H-1,2,4-triazole-1-yl)butane-2-ol

(2R,3R)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidino)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol

(2R,3R)-2-(2,4-difluorophenyl)-3-(4-methylidenepiperidin-1-yl)-1-(1,2,4-triazol-1-yl)butan-2-ol

(2r,3r)-2-(2,4-difluorophenyl)-3-(4-methylidenepiperidin-1-yl)-1-(1h-1,2,4-triazol-1-yl)butan-2-ol

1-Piperidineethanol, alpha-(2,4-difluorophenyl)-beta-methyl-4-methylene-alpha-(1H-1,2,4-triazol-1- ylmethyl)-, (alphaR,betaR)-

164650-44-6

164905-19-5

2856AH

AC1LAJ21

AK315814

AKOS027323571

AS-30126

BCP11665

C18H22F2N4O

CHEBI:82718

CHEMBL2103877

Clenafin (TN)

CS-3500

CTK5J2975

D10021

DB09040

DTXSID40167787

efinaconazol

Efinaconazole (JAN/USAN/INN)

Efinaconazole [USAN:INN]

Efinaconazole; KP-103

Efinaconazole(KP-103)

efinaconazolum

EX-A2643

HSDB 8341

HY-15660

J82SB7FXWB

JUBLIA

Jublia (TN)

KB-145948

KP-103

KP103

KS-00000SEK

MolPort-039-139-376

NCGC00390702-01

NFEZZTICAUWDHU-RDTXWAMCSA-N

SCHEMBL300738

UNII-J82SB7FXWB

ZINC6251

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

International Patents for efinaconazole

Country	Patent Number	Estimated Expiration
Singapore	11201602596U
Australia	5852400
Portugal	1205559
Mexico	2016004168
Spain	2532133