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Last Updated: July 22, 2024

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LUZU Drug Patent Profile


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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

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Summary for LUZU
International Patents:31
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 61
Patent Applications: 311
Drug Prices: Drug price information for LUZU
What excipients (inactive ingredients) are in LUZU?LUZU excipients list
DailyMed Link:LUZU at DailyMed
Drug patent expirations by year for LUZU
Drug Prices for LUZU

See drug prices for LUZU

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LUZU
Generic Entry Date for LUZU*:
Constraining patent/regulatory exclusivity:
NDA:
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 ClassAzole Antifungal
Mechanism of ActionCytochrome P450 2C19 Inhibitors

US Patents and Regulatory Information for LUZU

LUZU is protected by four US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of LUZU is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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

Method of evaluating pharmaceutical preparation containing luliconazole and index substance
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Crystal and pharmaceutical preparation containing the same crystal
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF FUNGAL INFECTIONS

Crystal having crystal habits and pharmaceutical composition obtained by processing the crystal
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Crystalline form having specific crystal habit and pharmaceutical composition containing this crystalline form as active ingredient
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Bausch LUZU luliconazole CREAM;TOPICAL 204153-001 Nov 14, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bausch LUZU luliconazole CREAM;TOPICAL 204153-001 Nov 14, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bausch LUZU luliconazole CREAM;TOPICAL 204153-001 Nov 14, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  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 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

Patent: 87488
Estimated Expiration: ⤷  Sign Up

Patent: 15114210
Patent: ルリコナゾールを含有する製剤の評価方法及び指標物質 (EVALUATION METHOD AND INDEX SUBSTANCE FOR FORMULATION CONTAINING LULICONAZOLE)
Estimated Expiration: ⤷  Sign Up

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
Norway 980055 ⤷  Sign Up
Denmark 176599 ⤷  Sign Up
South Africa 9605745 ⤷  Sign Up
Japan H09100279 ANTIFUNGAL AGENT, ITS COMPOUND, PRODUCTION THEREOF AND ITS USAGE ⤷  Sign Up
New Zealand 311796 R-(-)-(E)-[4-DICHLOROPHENYL]-1,3-DITHIOLAN-2-YLIDENE]-1-IMIDAZO LYLACETONITRILE, MEDICAMENTS CONTAINING THE SAME AND PROCESS FOR PRODUCING THE SAME ⤷  Sign Up
Russian Federation 2015109127 КРИСТАЛЛ, ОБЛАДАЮЩИЙ КРИСТАЛЛИЧЕСКИМИ ГАБИТУСАМИ, И ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, ПОЛУЧЕННАЯ ОБРАБОТКОЙ ДАННОГО КРИСТАЛЛА ⤷  Sign Up
World Intellectual Property Organization (WIPO) 9702821 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.