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LUZU Drug Profile

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When do Luzu patents expire, and what generic alternatives are available?

Luzu is a drug marketed by Medicis and is included in one NDA. There are five patents protecting this drug.

This drug has sixty-four patent family members in twenty-five countries.

The generic ingredient in LUZU is luliconazole. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the luliconazole profile page.

Summary for LUZU

International Patents:	64
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	36
Patent Applications:	23
Drug Prices:	see details
DailyMed Link:	LUZU at DailyMed

Pharmacology for LUZU

Ingredient-type	Azoles
Drug Class	Azole Antifungal
Mechanism of Action	Cytochrome P450 2C19 Inhibitors

Synonyms for LUZU

(-)-(E)-((4R)-4-(2,4-Dichlorophenyl)-1,3-dithiolan-2-ylidene)(1H-imidazol-1-yl)acetonitrile

(2E)-2-[(4R)-4-(2,4-dichlorophenyl)-1,3-dithiolan-2-ylidene]-2-imidazol-1-yl-acetonitrile

(2E)-2-[(4R)-4-(2,4-dichlorophenyl)-1,3-dithiolan-2-ylidene]-2-imidazol-1-ylacetonitrile

(R,E)-2-(4-(2,4-dichlorophenyl)-1,3-dithiolan-2-ylidene)-2-(1H-imidazol-1-yl)acetonitrile

164L198

187164-19-8

1H-Imidazole-1-acetonitrile, alpha-((4R)-4-(2,4-dichlorophenyl)-1,3-dithiolan-2-ylidene)-, (alphaE)-

2-[(2E,4R)-4-(2,4-dichlorophenyl)-1,3-dithiolan-2-ylidene]-2-(1H-imidazol-1-yl)acetonitrile

4-(2,4-Dichlorophenyl)-1,3-dithiolan-2-ylidene-1-imidazolylacetonitrile

AC1MHEOF

AKOS015897320

AM84645

AN-15036

BCP9000863

C13478

CAS-187164-19-8

CHEBI:34825

CHEMBL2105689

CS-0587

D01980

D0U4XJ

DB08933

DSSTox_CID_28533

DSSTox_GSID_48607

DSSTox_RID_82805

DTXSID3048607

GTPL7366

HE064141

HE320898

HY-14283

Imidazole antimycotic

JA-004

JA-005

Lulicon

Lulicon (TN)

Lulicon|||NND 502

Luliconazole

Luliconazole (JAN/USAN/INN)

Luliconazole [USAN:INN]

Luliconazole, >=98% (HPLC)

Lulifin

Luzu (TN)

MFCD00953915

MolPort-035-395-835

NCGC00182704-01

NCGC00182704-02

NCGC00182704-03

NND 502

NND-502

NND502

PR-2699

RE91AN4S8G

s4258

SCHEMBL342362

SR-01000945039

SR-01000945039-1

Tox21_112942

Tox21_112974

Tox21_112974_1

UNII-5JA16R08FJ component YTAOBBFIOAEMLL-REQDGWNSSA-N

UNII-RE91AN4S8G

W-5249

ZINC3929486

US Patents and Regulatory Information for LUZU

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Medicis	LUZU	luliconazole	CREAM;TOPICAL	204153-001	Nov 14, 2013		RX	Yes	Yes			Y	Y
Medicis	LUZU	luliconazole	CREAM;TOPICAL	204153-001	Nov 14, 2013		RX	Yes	Yes
Medicis	LUZU	luliconazole	CREAM;TOPICAL	204153-001	Nov 14, 2013		RX	Yes	Yes				Y
Medicis	LUZU	luliconazole	CREAM;TOPICAL	204153-001	Nov 14, 2013		RX	Yes	Yes			Y	Y

Non-Orange Book US Patents for LUZU

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
9,085,554	Method of evaluating pharmaceutical preparation containing luliconazole and index substance

International Patents for LUZU

Country	Document Number	Estimated Expiration
China	1091596
Taiwan	450969
Russian Federation	2603963
Russian Federation	2015113638