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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Questions you can ask:
- What is the 5 year forecast for LUZU?
- What are the global sales for LUZU?
- What is Average Wholesale Price for LUZU?
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 |
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 Class | Azole Antifungal |
Mechanism of Action | Cytochrome 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 | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
---|---|---|---|
Luxembourg | 90190 | ⤷ Sign Up | |
Japan | H09100279 | ANTIFUNGAL AGENT, ITS COMPOUND, PRODUCTION THEREOF AND ITS USAGE | ⤷ Sign Up |
Japan | 2015027972 | 結晶及び該結晶を含有してなる医薬製剤 (CRYSTAL AND PHARMACEUTICAL PREPARATION CONTAINING THE CRYSTAL) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |