Generic Noxafil Availability
Last updated on Apr 10, 2025.
Noxafil is a brand name of posaconazole, approved by the FDA in the following formulation(s):
NOXAFIL (posaconazole - solution;intravenous)
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Manufacturer: MERCK SHARP DOHME
Approval date: March 13, 2014
Strength(s): 300MG/16.7ML (18MG/ML) [RLD] [AP]
NOXAFIL (posaconazole - suspension;oral)
NOXAFIL (posaconazole - tablet, delayed release;oral)
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Manufacturer: MERCK SHARP DOHME
Approval date: November 25, 2013
Strength(s): 100MG (discontinued) [RLD]
Is there a generic version of Noxafil available?
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
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Manufacturer: ASPIRO
Approval date: December 23, 2024
Strength(s): 300MG/16.7ML (18MG/ML) [AP] -
Manufacturer: ENDO OPERATIONS
Approval date: May 25, 2022
Strength(s): 300MG/16.7ML (18MG/ML) [AP] -
Manufacturer: EUGIA PHARMA
Approval date: December 26, 2023
Strength(s): 300MG/16.7ML (18MG/ML) [AP] -
Manufacturer: FRESENIUS KABI USA
Approval date: December 26, 2023
Strength(s): 300MG/16.7ML (18MG/ML) [AP] -
Manufacturer: GLAND
Approval date: December 26, 2023
Strength(s): 300MG/16.7ML (18MG/ML) [AP] -
Manufacturer: MYLAN LABS LTD
Approval date: December 26, 2023
Strength(s): 300MG/16.7ML (18MG/ML) [AP]
posaconazole suspension;oral
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Manufacturer: HIKMA
Approval date: May 15, 2020
Strength(s): 40MG/ML [AB]
Note: No generic formulation of the following product is available.
- posaconazole - tablet, delayed release;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.
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Sulfoalkyl ether cyclodextrin compositions
Patent 10,117,951
Issued: November 6, 2018
Inventor(s): Antle Vincent D.
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✓
- March 13, 2029
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Sulfoalkyl ether cyclodextrin compositions
Patent 8,410,077
Issued: April 2, 2013
Inventor(s): Antle Vincent
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✓
- March 13, 2029
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Posaconazole intravenous solution formulations stabilized by substituted β-cyclodextrin
Patent 9,023,790
Issued: May 5, 2015
Inventor(s): Heimbecher Susan K. & Monteith David & Pipkin James D.
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✓✓
- July 4, 2031✓✓
- July 4, 2031✓✓
- July 4, 2031
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Posaconazole intravenous solution formulations stabilized by substituted β-cyclodextrin
Patent 9,358,297
Issued: June 7, 2016
Inventor(s): Heimbecher Susan K. & Monteith David & Pipkin James D.
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✓✓
- June 24, 2031✓✓
- June 24, 2031
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Alkylated cyclodextrin compositions and processes for preparing and using the same
Patent 9,493,582
Issued: November 15, 2016
Inventor(s): Antle Vincent D. & Lopes Alvaro & Monteiro Daniel
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✓
- February 27, 2033
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Sulfoalkyl ether cyclodextrin compositions
Patent 9,750,822
Issued: September 5, 2017
Inventor(s): Antle Vincent D.
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✓
- March 13, 2029
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 17, 2028 - FOR THE TREATMENT OF INVASIVE ASPERGILLOSIS IN ADULTS AND PEDIATRIC PATIENTS 13 YEARS OF AGE AND OLDER
More about Noxafil (posaconazole)
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Patient resources
- Noxafil drug information
- Noxafil (Posaconazole Intravenous) (Advanced Reading)
- Noxafil (Posaconazole Oral) (Advanced Reading)
- Noxafil PowderMix (Advanced Reading)
Professional resources
Related treatment guides
Glossary
Term | Definition |
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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.