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Generic Fetzima Availability

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

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

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

Has a generic version of Fetzima been approved?

No. There is currently no therapeutically equivalent version of Fetzima available in the United States.

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: About generic drugs.

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:
    • June 3, 2023
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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:
    • July 25, 2018 - NEW CHEMICAL ENTITY (AN ENANTIOMER OF PREVIOUSLY APPROVED RACEMIC MIXTURE. SEE SECTION 505(U) OF THE FEDERAL FOOD AND DRUG COSMETIC ACT).

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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