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LUZU Drug Profile
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When do Luzu patents expire, and when can generic versions of Luzu launch?
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 six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the luliconazole profile page.
US ANDA Litigation and 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: | 64 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 50 |
Patent Applications: | 356 |
Drug Prices: | Drug price information for LUZU |
What excipients (inactive ingredients) are in LUZU? | LUZU excipients list |
DailyMed Link: | LUZU at DailyMed |


Generic Entry Opportunity 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
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 | Start Trial | Start Trial | Y | Y | Start Trial | ||
Medicis | LUZU | luliconazole | CREAM;TOPICAL | 204153-001 | Nov 14, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
Medicis | LUZU | luliconazole | CREAM;TOPICAL | 204153-001 | Nov 14, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
>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 |
---|---|---|---|---|---|---|---|
Medicis | LUZU | luliconazole | CREAM;TOPICAL | 204153-001 | Nov 14, 2013 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LUZU
Country | Patent Number | Estimated Expiration |
---|---|---|
Japan | 5698395 | Start Trial |
Sweden | 9800016 | Start Trial |
Hong Kong | 1009751 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |