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Generic Noxafil Availability

Last updated on Aug 10, 2022.

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] [AP]

NOXAFIL (posaconazole - suspension;oral)

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

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 solution;intravenous

  • Manufacturer: PAR STERILE PRODUCTS
    Approval date: May 25, 2022
    Strength(s): 300MG/16.7ML (18MG/ML) [AP]

posaconazole tablet, delayed release;oral

  • Manufacturer: AET PHARMA
    Approval date: February 1, 2021
    Strength(s): 100MG [AB]
  • Manufacturer: BIOCON PHARMA
    Approval date: February 4, 2022
    Strength(s): 100MG [AB]
  • Manufacturer: DR REDDYS
    Approval date: April 7, 2022
    Strength(s): 100MG [AB]
  • Manufacturer: SINOTHERAPEUTICS INC
    Approval date: August 21, 2019
    Strength(s): 100MG [AB]
  • Manufacturer: SPECGX LLC
    Approval date: May 10, 2022
    Strength(s): 100MG [AB]

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

  • posaconazole - suspension;oral

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 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.

  • 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
      ✓ 
      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
      ✓ 
      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: TREATMENT OF INVASIVE ASPERGILLOSIS IN ADULTS AND PEDIATRIC PATIENTS 13 YEARS OF AGE AND OLDER
      ✓ 
      Drug product
    • July 4, 2031
      ✓ 
      Patent use: PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS
      ✓ 
      Drug product
    • July 4, 2031
      ✓ 
      Patent use: PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WHO ARE SEVERELY IMMUNOCOMPROMISED
      ✓ 
      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: TREATMENT OF INVASIVE ASPERGILLOSIS IN ADULTS AND PEDIATRIC PATIENTS 13 YEARS OF AGE AND OLDER
      ✓ 
      Drug product
    • June 24, 2031
      ✓ 
      Patent use: PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WHO ARE SEVERELY IMMUNOCOMPROMISED
      ✓ 
      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
      ✓ 
      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

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:

    • May 31, 2024 - NEW PATIENT POPULATION
    • June 17, 2024 - FOR THE TREATMENT OF INVASIVE ASPERGILLOSIS IN PATIENTS 13 YEARS OF AGE AND OLDER
    • June 17, 2028 - FOR THE TREATMENT OF INVASIVE ASPERGILLOSIS IN ADULTS AND PEDIATRIC PATIENTS 13 YEARS OF AGE AND OLDER

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 (e.g. identical active ingredients, dosage form, and routes 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 (e.g. AB1, AB2, AB7). 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.
AP Injectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions. It should be noted that even though injectable (parenteral) products under a specific listing may be evaluated as therapeutically equivalent, there may be important differences among the products in the general category, Injectable; Injection. For example, some injectable products that are rated therapeutically equivalent are labeled for different routes of administration. In addition, some products evaluated as therapeutically equivalent may have different preservatives or no preservatives at all. Injectable products available as dry powders for reconstitution, concentrated sterile solutions for dilution, or sterile solutions ready for injection are pharmaceutical alternative drug products. They are not rated as therapeutically equivalent (AP) to each other even if these pharmaceutical alternative drug products are designed to produce the same concentration prior to injection and are similarly labeled. Consistent with accepted professional practice, it is the responsibility of the prescriber, dispenser, or individual administering the product to be familiar with a product's labeling to assure that it is given only by the route(s) of administration stated in the labeling.

Further information

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