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Generic Noxafil Availability

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

NOXAFIL (posaconazole - solution;intravenous)

  • Manufacturer: MERCK SHARP DOHME
    Approval date: March 13, 2014
    Strength(s): 300MG/16.7ML (18MG/ML) [RLD]

NOXAFIL (posaconazole - suspension;oral)

  • Manufacturer: SCHERING
    Approval date: September 15, 2006
    Strength(s): 40MG/ML [RLD] [AB]

NOXAFIL (posaconazole - tablet, delayed release;oral)

Has a generic version of Noxafil been approved?

A generic version of Noxafil 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 Noxafil and have been approved by the FDA:

posaconazole suspension;oral

  • Manufacturer: HIKMA
    Approval date: May 15, 2020
    Strength(s): 40MG/ML [AB]

posaconazole tablet, delayed release;oral

  • Manufacturer: SINOTHERAPEUTICS INC
    Approval date: August 21, 2019
    Strength(s): 100MG [AB]

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

  • posaconazole - solution;intravenous

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

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.

  • Sulfoalkyl ether cyclodextrin compositions
    Patent 10,117,951
    Issued: November 6, 2018
    Assignee(s): CyDex Pharmaceuticals, Inc.

    SAE-CD compositions are provided, along with methods of making and using the same. The SAE-CD compositions comprise a sulfoalkyl ether cyclodextrin having an absorption of less than 0.5 A.U. due to a drug-degrading agent, as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 300 mg of the SAE-CD composition per mL of solution in a cell having a 1 cm path length.

    Patent expiration dates:

    • March 13, 2029
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      Drug product
  • Antifungal composition with enhanced bioavailability
    Patent 8,263,600
    Issued: September 11, 2012
    Inventor(s): Sharpe; Stefan & Sequeira; Joel & Harris; David & Mahashabde; Shashank
    Assignee(s): Merck Sharp & Dohme Corp.

    A liquid suspension comprising an antifungally effective amount of the micronized compound represented by the chemical structural formula I: at least one thickening agent, a non-ionic surfactant, and a pharmaceutically acceptable liquid carrier is disclosed.

    Patent expiration dates:

    • April 1, 2022
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      Drug product
  • Sulfoalkyl ether cyclodextrin compositions
    Patent 8,410,077
    Issued: April 2, 2013
    Assignee(s): CyDex Pharmaceuticals, Inc.

    SAE-CD compositions are provided, along with methods of making and using the same. The SAE-CD compositions comprise a sulfoalkyl ether cyclodextrin having an absorption of less than 0.5 A.U. due to a drug-degrading agent, as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 300 mg of the SAE-CD composition per mL of solution in a cell having a 1 cm path length.

    Patent expiration dates:

    • March 13, 2029
      ✓ 
      Drug product
  • Posaconazole intravenous solution formulations stabilized by substituted β-cyclodextrin
    Patent 9,023,790
    Issued: May 5, 2015
    Assignee(s): Merck Sharp & Dohme Corp.

    The present invention relates to aqueous solutions useful as pharmaceutical compositions of posaconazole for intravenous administration. These compositions include a solubilizing agent, such as a modified β-cyclodextrin in an acidified solution, which can also include a chelating agent such as disodium edetate (EDTA). In clinical trials, a 200 mg posaconazole dose of the selected composition was found to achieve acceptable pharmacokinetic properties.

    Patent expiration dates:

    • July 4, 2031
      ✓ 
      Patent use: PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS
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      Drug product
  • Posaconazole intravenous solution formulations stabilized by substituted β-cyclodextrin
    Patent 9,358,297
    Issued: June 7, 2016
    Assignee(s): Merck Sharp & Dohme Corp.

    The present invention relates to aqueous solutions useful as pharmaceutical compositions of posaconazole for intravenous administration. These compositions include a solubilizing agent, such as a modified β-cyclodextrin in an acidified solution, which can also include a chelating agent such as disodium edetate (EDTA). In clinical trials, a 200 mg posaconazole dose of the selected composition was found to achieve acceptable pharmacokinetic properties.

    Patent expiration dates:

    • June 24, 2031
      ✓ 
      Patent use: PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS
      ✓ 
      Drug product
  • Alkylated cyclodextrin compositions and processes for preparing and using the same
    Patent 9,493,582
    Issued: November 15, 2016
    Assignee(s): Cydex Pharmaceuticals, Inc.

    The present invention related to low-chloride alkylated cyclodextrin compositions, along with processes for preparing and using the same. The processes of the present invention provide alkylated cyclodextrins with low levels of drug-degrading agents and chloride.

    Patent expiration dates:

    • February 27, 2033
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      Drug product
  • Sulfoalkyl ether cyclodextrin compositions
    Patent 9,750,822
    Issued: September 5, 2017
    Assignee(s): Cydex Pharmaceuticals, Inc.

    SAE-CD compositions are provided, along with methods of making and using the same. The SAE-CD compositions comprise a sulfoalkyl ether cyclodextrin having an absorption of less than 0.5 A.U. due to a drug-degrading agent, as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 300 mg of the SAE-CD composition per mL of solution in a cell having a 1 cm path length.

    Patent expiration dates:

    • March 13, 2029
      ✓ 
      Drug product

Further information

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

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.
AB Products 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.