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Generic Jublia Availability

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

JUBLIA (efinaconazole - solution;topical)

  • Manufacturer: DOW PHARM
    Approval date: June 6, 2014
    Strength(s): 10% [RLD]

Has a generic version of Jublia been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Jublia. 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 onychomycosis
    Patent 7,214,506
    Issued: May 8, 2007
    Inventor(s): Tatsumi; Yoshiyuki & Yokoo; Mamoru & Nakamura; Kosho & Arika; Tadashi
    Assignee(s): Kaken Pharmaceutical Co., Ltd.
    A novel method for evaluating an effect of an antimicrobial agent which comprises removing the antimicrobial agent remaining in a biological sample or the like to thereby accurately evaluate the effect of the antimicrobial agent without being affected by the remaining antimicrobial agent. A therapeutic agent for onychomycosis which can be obtained according to the evaluation method of the drug effect.
    Patent expiration dates:
    • October 5, 2021
      ✓ 
      Patent use: ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS
  • Compositions and methods for treating diseases of the nail
    Patent 8,039,494
    Issued: October 18, 2011
    Inventor(s): Winckle; Gareth & Fieldson; Gregory T.
    Assignee(s): Dow Pharmaceutical Sciences, Inc.
    Methods and compositions for treating disorders of the nail and nail bed. Such compositions contain a vehicle in which all components of the composition are dissolved, suspended, dispersed, or emulsified, a non-volatile solvent, a wetting agent, and a pharmaceutically active ingredient that is soluble in the non-volatile solvent and/or a mixture of the vehicle and the non-volatile solvent, which composition has a surface tension of 40 dynes/cm or less and has continuing spreadability, and which composition is effective in treating a disorder of the nail or nail bed.
    Patent expiration dates:
    • July 8, 2030
      ✓ 
      Patent use: ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS
  • Compositions and methods for treating diseases of the nail
    Patent 8,486,978
    Issued: July 16, 2013
    Assignee(s): Dow Pharmaceutical Sciences, Inc.
    Methods and compositions for treating disorders of the nail and nail bed. Such compositions contain a vehicle in which all components of the composition are dissolved, suspended, dispersed, or emulsified, a non-volatile solvent, a wetting agent, and a pharmaceutically active ingredient that is soluble in the non-volatile solvent and/or a mixture of the vehicle and the non-volatile solvent, which composition has a surface tension of 40 dynes/cm or less and has continuing spreadability, and which composition is effective in treating a disorder of the nail or nail bed.
    Patent expiration dates:
    • October 24, 2030
      ✓ 
      Drug product
  • Compositions and methods for treating diseases of the nail
    Patent 9,302,009
    Issued: April 5, 2016
    Assignee(s): Dow Pharmaceutical Sciences, Inc.
    Methods and compositions for treating disorders of the nail and nail bed. Such compositions contain a vehicle in which all components of the composition are dissolved, suspended, dispersed, or emulsified, a non-volatile solvent, a wetting agent, and a pharmaceutically active ingredient that is soluble in the non-volatile solvent and/or a mixture of the vehicle and the non-volatile solvent, which composition has a surface tension of 40 dynes/cm or less and has continuing spreadability, and which composition is effective in treating a disorder of the nail or nail bed.
    Patent expiration dates:
    • October 24, 2030
      ✓ 
      Drug product

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:
    • June 6, 2019 - 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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