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Generic Fetzima Availability

Last updated on Sep 8, 2021.

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

FETZIMA (levomilnacipran hydrochloride - capsule, extended release;oral)

  • Manufacturer: ALLERGAN
    Approval date: July 25, 2013
    Strength(s): EQ 20MG BASE [RLD] [AB], EQ 40MG BASE [RLD] [AB], EQ 80MG BASE [RLD] [AB], EQ 120MG BASE [RLD] [AB]

Has a generic version of Fetzima been approved?

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

levomilnacipran hydrochloride capsule, extended release;oral

  • Manufacturer: HIKMA PHARMS
    Approval date: November 5, 2020
    Strength(s): EQ 20MG BASE [AB], EQ 40MG BASE [AB], EQ 80MG BASE [AB], EQ 120MG BASE [AB]

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

  • Stable dosage forms of levomilnacipran
    Patent 8,481,598
    Issued: July 9, 2013

    The present invention relates to stable dosage forms of levomilnacipran and pharmaceutically acceptable salts thereof. Processes for the preparation of these dosage forms and methods of using these dosage forms are also described.

    Patent expiration dates:

    • March 2, 2031
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      Patent use: TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
  • Crystalline forms of (1S,2R)-2-(amino methyl)-N,N-diethyl-1-phenyl cyclopropane carboxamide
    Patent 8,865,937
    Issued: October 21, 2014

    The present invention relates to novel crystalline forms of (1S,2R)-2-(amino methyl)-N,N-diethyl-1-phenyl cyclopropane carboxamide. Processes for the preparation of this form, compositions containing the form, and methods of use thereof are also described.

    Patent expiration dates:

    • May 23, 2032
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      Drug substance
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      Drug product
  • Use of the dextrogyral enantiomer of milnacipran for the preparation of a drug
    Patent RE43879
    Issued: December 25, 2012
    Inventor(s): Deregnaucourt; Jean & Grosse; Richard
    Assignee(s): Pierre Fabre Medicament

    The present invention concerns the use of a mixture of enantiomers enriched in the dextrogyral enantiomer of milnacipran and/or of at least one of its metabolites, as well as their pharmaceutically-acceptable salts, for the preparation of a drug intended to prevent or to treat disorders that can be managed by double inhibition of serotonin (5-HT) and norepinephrine (NE) reuptake, while limiting the risks of cardiovascular disturbances and/or organ and/or tissue toxicity.

    Patent expiration dates:

    • January 11, 2026
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      Patent use: TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)

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:

    • October 7, 2022 - INFORMATION ADDED TO THE LABELING TO DESCRIBE STUDY LVM-MD-15 TO FULFILL POSTMARKETING COMMITMENT 1943-4

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.

Further information

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