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Generic Mycamine Availability

Last updated on Nov 8, 2022.

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

MYCAMINE (micafungin sodium - injectable;intravenous)

  • Manufacturer: ASTELLAS
    Approval date: March 16, 2005
    Strength(s): EQ 50MG BASE/VIAL [RLD] [AP]
  • Manufacturer: ASTELLAS
    Approval date: June 27, 2006
    Strength(s): EQ 100MG BASE/VIAL [RLD] [AP]

Has a generic version of Mycamine been approved?

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

micafungin sodium injectable;intravenous

  • Manufacturer: APOTEX
    Approval date: November 5, 2020
    Strength(s): EQ 50MG BASE/VIAL [AP], EQ 100MG BASE/VIAL [AP]
  • Manufacturer: FRESENIUS KABI USA
    Approval date: May 17, 2019
    Strength(s): EQ 50MG BASE/VIAL [AP], EQ 100MG BASE/VIAL [AP]
  • Manufacturer: HIKMA
    Approval date: July 9, 2021
    Strength(s): EQ 50MG BASE/VIAL [AP], EQ 100MG BASE/VIAL [AP]
  • Manufacturer: JIANGSU HANSOH PHARM
    Approval date: July 9, 2021
    Strength(s): EQ 50MG BASE/VIAL [AP], EQ 100MG BASE/VIAL [AP]
  • Manufacturer: NANJING KING-FRIEND
    Approval date: September 28, 2022
    Strength(s): EQ 50MG BASE/VIAL [AP], EQ 100MG BASE/VIAL [AP]
  • Manufacturer: XELLIA PHARMS APS
    Approval date: June 2, 2021
    Strength(s): EQ 50MG BASE/VIAL [AP], EQ 100MG BASE/VIAL [AP]
  • Manufacturer: ZYDUS PHARMS
    Approval date: October 24, 2022
    Strength(s): EQ 50MG BASE/VIAL [AP], EQ 100MG BASE/VIAL [AP]

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

    • December 20, 2022 - TREATMENT OF CANDIDEMIA, ACUTE DISSEMINATED CANDIDIASIS, CANDIDA PERITONITIS AND ABSCESSES WITHOUT MENINGOENCEPHALITIS AND/OR OCULAR DISSEMINATION IN PEDIATRIC PATIENTS YOUNGER THAN 4 MONTHS OF AGE
    • June 20, 2023 - PEDIATRIC EXCLUSIVITY

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.
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.

Medical Disclaimer