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Generic Luzu Availability

Luzu is a brand name of luliconazole topical, approved by the FDA in the following formulation(s):

LUZU (luliconazole - cream;topical)

  • Manufacturer: MEDICIS
    Approval date: November 14, 2013
    Strength(s): 1% [RLD]

Has a generic version of Luzu been approved?

No. There is currently no therapeutically equivalent version of Luzu available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Luzu. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Method for treating mycosis using imidazolylacetonitrile derivatives
    Patent 5,900,488
    Issued: May 4, 1999
    Inventor(s): Kodama; Hiroki & Niwano; Yoshimi & Kanai; Kazuo & Yoshida; Masanori
    Assignee(s): Nihon Nohyaku Co., Ltd.
    R-(+)-(E)-›4-(2-Chlorophenyl)-1,3-dithiolan-2-ylidene!-1-imidazolylacetonit rile, R-(-)-(E)-›4-(2,4-dichlorophenyl)-1,3-dithiolan-2-ylidene!-1-imidazolylace tonitrile, and pharmaceutically acceptable salts thereof which can be used as a pharmaceutical agent are disclosed. A process for producing them and a method for treating mycoses using them are also disclosed.
    Patent expiration dates:
    • July 5, 2017
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      Patent use: TREATMENT OF FUNGAL INFECTIONS
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  • Method of evaluating pharmaceutical preparation containing luliconazole and index substance
    Patent 8,980,931
    Issued: March 17, 2015
    Assignee(s): Pola Pharma Inc. Nihon Nohyaku Co., Ltd.
    Disclosed is a method of evaluating stability of a pharmaceutical preparation containing luliconazole. The method includes measuring an amount of production of an SE form of luliconazole represented by following formula (2), an amount of production of a Z form of luliconazole represented by following formula (3) and an amount of production of an amide form of luliconazole represented by following formula (1) after storage under a severe condition or an accelerated condition, and judging that the stability of the pharmaceutical preparation is high if each of the amount of production of the SE form, the amount of production of the Z form and the amount of production of the amide form is not more than 5% by weight with respect to a compounded amount of luliconazole.
    Patent expiration dates:
    • April 28, 2034
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      Drug product
  • Crystal and pharmaceutical preparation containing the same crystal
    Patent 9,012,484
    Issued: April 21, 2015
    Assignee(s): Pola Pharma Inc. Nihon Nohyaku Co., Ltd.
    An object is to provide means for improving the solubility of luliconazole. Disclosed is a crystal consisting of luliconazole and short chain alcohol having a number of carbon atom or atoms of 1 to 4.
    Patent expiration dates:
    • September 6, 2033
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      Patent use: TREATMENT OF FUNGAL INFECTIONS
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  • Crystal having crystal habits and pharmaceutical composition obtained by processing the crystal
    Patent 9,199,977
    Issued: December 1, 2015
    Assignee(s): POLA PHARMA INC. NIHON NOHYAKU CO., LTD.
    An object is to provide means for improving the solubility of luliconazole. Disclosed is a crystal of luliconazole wherein the crystal has such a crystal habit that (021) plane is a specific crystal growth plane.
    Patent expiration dates:
    • September 6, 2033
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  • Crystalline form having specific crystal habit and pharmaceutical composition containing this crystalline form as active ingredient
    Patent 9,453,006
    Issued: September 27, 2016
    Assignee(s): POLA PHARMA INC. NIHON NOHYAKU CO., LTD.
    Means for improving the solubility of luliconazole is provided. A crystal of luliconazole represented by the following formula is provided, wherein the crystal has such a crystal habit that (011) plane is a specific crystal growth plane. The crystal is characterized in that I(011) with respect to a sum total of I(001), I(100), I(10-1), I(011), I(110), I(11-1), I(10-2), I(11-2), I(020), I(021), I(20-2), I(121), I(013), I(11-3), and I(221) is not less than 25%, provided that integrated intensities of diffraction peaks, which correspond to the (001), (100), (10-1), (011), (110), (11-1), (10-2), (11-2), (020), (021), (20-2), (121), (013), (11-3), and (221) planes, are designated as I(001), I(100), I(10-1), I(011), I(110), I(11-1), I(10-2), I(11-2), I(020), I(021), I(20-2), I(121), I(013), I(11-3), and I(221) respectively in relation to the diffraction peaks detected in a range of 2θ=5 to 35° in a powder X-ray diffractometry using CuKα radiation.
    Patent expiration dates:
    • September 6, 2033
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      Drug substance

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • November 14, 2018 - NEW CHEMICAL ENTITY

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
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