Generic Sporanox Availability

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

SPORANOX (itraconazole - capsule;oral)

SPORANOX (itraconazole - solution;oral)

  • Manufacturer: JANSSEN PHARMS
    Approval date: February 21, 1997
    Strength(s): 10MG/ML [RLD]

Has a generic version of Sporanox been approved?

A generic version of Sporanox has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Sporanox and have been approved by the FDA:

itraconazole capsule;oral

  • Manufacturer: MYLAN PHARMS INC
    Approval date: July 20, 2012
    Strength(s): 100MG [AB]
  • Manufacturer: SANDOZ
    Approval date: May 28, 2004
    Strength(s): 100MG [AB]

Note: No generic formulation of the following product is available.

  • itraconazole - solution;oral

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Sporanox. 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.

  • Beads having a core coated with an antifungal and a polymer
    Patent 5,633,015
    Issued: May 27, 1997
    Inventor(s): Gilis; Paul M. V. & De Conde ; Valentin F. V. & Vandecruys; Roger P. G.
    The present invention is concerned with beads comprising a 25-30 mesh core, a coating of a hydrophilic polymer and an antifungal agent, and a seal outer coating layer; pharmaceutical dosage forms comprising said beads and a method of preparing said beads. Preferred antifungal agents are lipophilic azole antifungals, such as itraconazole and saperconazole.
    Patent expiration dates:
    • May 27, 2014
  • Oral formulations on an antifungal
    Patent 5,707,975
    Issued: January 13, 1998
    Inventor(s): Fran.cedilla.ois; Marc Karel Jozef & Dries; Willy Maria Albert Carlo
    Assignee(s): Janssen Pharmaceutica, N.V.
    The present invention concerns a formulation for oral administration comprising an antifungal, a sufficient amount of a cyclodextrin or a derivative thereof, an aqueous acidic medium as bulk liquid carrier and an alcoholic co-solvent Addition of one or more pharmaceutically acceptable sweeteners and one or more pharmaceutically acceptable flavors thereto yields palatable oral formulations. A process of preparing such formulations and pharmaceutical dosage forms comprising said formulations.
    Patent expiration dates:
    • January 13, 2015
  • Pharmaceutical compositions containing drugs which are instable or sparingly soluble in water and methods for their preparation
    Patent 6,407,079
    Issued: June 18, 2002
    Inventor(s): Bernd W.; Müller & Ulrich; Brauns
    Assignee(s): Janssen Pharmaceutica N.V.
    Pharmaceutical compositions comprising inclusion compounds of sparingly water-soluble or water-instable drugs with &bgr;-cyclodextrin ethers or &bgr;-cyclodextrin esters and process for the preparation thereof.
    Patent expiration dates:
    • June 18, 2019

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.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.
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