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Last Updated: March 28, 2024

LULICONAZOLE - Generic Drug Details


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

Luliconazole is the generic ingredient in one branded drug marketed by Bausch and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Luliconazole has thirty-one patent family members in seven countries.

There are six drug master file entries for luliconazole. Two suppliers are listed for this compound.

Summary for LULICONAZOLE
International Patents:31
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 6
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 61
Clinical Trials: 8
Patent Applications: 45
Drug Prices: Drug price trends for LULICONAZOLE
What excipients (inactive ingredients) are in LULICONAZOLE?LULICONAZOLE excipients list
DailyMed Link:LULICONAZOLE at DailyMed
Drug Prices for LULICONAZOLE

See drug prices for LULICONAZOLE

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LULICONAZOLE
Generic Entry Date for LULICONAZOLE*:
Constraining patent/regulatory exclusivity:
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.

Recent Clinical Trials for LULICONAZOLE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
SATO Pharmaceutical Co., Ltd.Phase 1
Valeant PharmaceuticalsPhase 4
Valeant Pharmaceuticals International, Inc.Phase 4

See all LULICONAZOLE clinical trials

Pharmacology for LULICONAZOLE
Drug ClassAzole Antifungal
Mechanism of ActionCytochrome P450 2C19 Inhibitors

US Patents and Regulatory Information for LULICONAZOLE

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 ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Bausch LUZU luliconazole CREAM;TOPICAL 204153-001 Nov 14, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bausch LUZU luliconazole CREAM;TOPICAL 204153-001 Nov 14, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 LULICONAZOLE

Country Patent Number Title Estimated Expiration
Japan 2014172858 CRYSTAL HAVING CRYSTAL HABIT AND PHARMACEUTICAL COMPOSITION CONTAINING THE CRYSTAL AS ACTIVE COMPONENT ⤷  Try a Trial
China 105026390 Crystalline form having specific crystal habit and pharmaceutical composition containing this crystalline form as active ingredient ⤷  Try a Trial
European Patent Office 2964641 FORME CRISTALLINE À HABITUDE CRISTALLINE SPECIFIQUE ET COMPOSITION PHARMACEUTIQUE CONTENANT CETTE FORME CRISTALLINE COMME INGRÉDIENT ACTIF (CRYSTALLINE FORM HAVING SPECIFIC CRYSTAL HABIT AND PHARMACEUTICAL COMPOSITION CONTAINING THIS CRYSTALLINE FORM AS ACTIVE INGREDIENT) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

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.