LUZU Drug Patent Profile

When do Luzu patents expire, and when can generic versions of Luzu launch?

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

This drug has thirty-one patent family members in seven countries.

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

DrugPatentWatch^® Generic Entry Outlook for Luzu

Luzu was eligible for patent challenges on November 14, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 28, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LUZU

International Patents:	31
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	60
Patent Applications:	28
Drug Prices:	Drug price information for LUZU
What excipients (inactive ingredients) are in LUZU?	LUZU excipients list
DailyMed Link:	LUZU at DailyMed

See drug prices for LUZU

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LUZU

NDA:

204153

Dosage:

CREAM;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for LUZU

Drug Class	Azole Antifungal
Mechanism of Action	Cytochrome P450 2C19 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for LUZU

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

US Patents and Regulatory Information for LUZU

LUZU is protected by four US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting LUZU

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

Expired US Patents for LUZU

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	LUZU	luliconazole	CREAM;TOPICAL	204153-001	Nov 14, 2013

International Patents for LUZU

When does loss-of-exclusivity occur for LUZU?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Japan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LUZU around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2014042231
South Korea	101751726
Finland	119357
Japan	2015091890	結晶及び該結晶を含有してなる医薬製剤 (CRYSTAL AND PHARMACEUTICAL FORMULATION COMPRISING THE CRYSTAL)