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Generic Tolsura Availability

Last updated on Oct 6, 2021.

Tolsura is a brand name of itraconazole, approved by the FDA in the following formulation(s):

TOLSURA (itraconazole - capsule;oral)

  • Manufacturer: MAYNE PHARMA INTL
    Approval date: December 11, 2018
    Strength(s): 65MG [RLD]

Has a generic version of Tolsura been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Tolsura. 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: Generic Drug FAQ.

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.

  • Patent 10,463,740

    Patent expiration dates:

    • June 21, 2033
      ✓ 
      Patent use: TREATMENT OF FUNGAL INFECTIONS, INCLUDING BLASTOMYCOSIS, HISTOPLASMOSIS, AND ASPERGILLOSIS
      ✓ 
      Drug product
  • Patent 10,806,792

    Patent expiration dates:

    • June 21, 2033
      ✓ 
      Drug product
  • Pharmaceutical compositions for poorly soluble drugs
    Patent 8,771,739
    Issued: July 8, 2014
    Assignee(s): Mayne Pharma International Pty Ltd

    The present invention provides a pharmaceutical composition of a practically insoluble drug, wherein the composition may be administered with food or without food. The composition may be in the form of a solid dispersion of the practically insoluble drug and a polymer having acidic functional groups, and the composition may in vitro form a suspension.

    Patent expiration dates:

    • July 25, 2023
      ✓ 
      Drug product
  • Itraconazole compositions and dosage forms, and methods of using the same
    Patent 8,921,374
    Issued: December 30, 2014
    Assignee(s): Mayne Pharma International Pty Ltd

    The disclosure relates to, among other things, pharmaceutical compositions, such as solid oral dosage forms, comprising itraconazole, methods of making the compositions, and methods of using the same for treating disorders including, but not limited to, fungal infections.

    Patent expiration dates:

    • June 21, 2033
      ✓ 
      Drug product
  • Itraconazole compositions and dosage forms, and methods of using the same
    Patent 9,272,046
    Issued: March 1, 2016
    Assignee(s): MAYNE PHARMA INTERNATIONAL PTY. LTD.

    The disclosure relates to, among other things, pharmaceutical compositions, such as solid oral dosage forms, comprising itraconazole, methods of making the compositions, and methods of using the same for treating disorders including, but not limited to, fungal infections.

    Patent expiration dates:

    • June 21, 2033
      ✓ 
      Drug product
  • Itraconazole compositions and dosage forms, and methods of using the same
    Patent 9,713,642
    Issued: July 25, 2017
    Assignee(s): MAYNE PHARMA INTERNATIONAL PTY. LTD.

    The disclosure relates to, among other things, pharmaceutical compositions, such as solid oral dosage forms, comprising itraconazole, methods of making the compositions, and methods of using the same for treating disorders including, but not limited to, fungal infections.

    Patent expiration dates:

    • June 21, 2033
      ✓ 
      Patent use: TREATMENT OF FUNGAL INFECTIONS, INCLUDING BLASTOMYCOSIS, HISTOPLASMOSIS, AND ASPERGILLOSIS

Glossary

Term Definition
Drug Patent A 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 Exclusivity Exclusivity 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.
RLD A 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.