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Generic Vivitrol Availability

Last updated on Sep 8, 2021.

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

VIVITROL (naltrexone - for suspension, extended release;intramuscular)

  • Manufacturer: ALKERMES
    Approval date: April 13, 2006
    Strength(s): 380MG/VIAL [RLD]

Has a generic version of Vivitrol been approved?

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

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

  • Naltrexone long acting formulations and methods of use
    Patent 7,919,499
    Issued: April 5, 2011
    Inventor(s): Ehrich; Elliot
    Assignee(s): Alkermes, Inc.

    The inventions described herein arose from unexpected discoveries made during clinical trials with a long acting formulation of naltrexone. As such, the invention includes a method for treating an individual in need of naltrexone comprising the step of parenterally administering a long acting formulation comprising naltrexone and to the use of naltrexone in the manufacture of medicaments for use in such methods.

    Patent expiration dates:

    • October 15, 2029
      ✓ 
      Patent use: PREVENTION OF RELAPSE TO OPIOID DEPENDENCE, FOLLOWING OPIOID DETOXIFICATION
    • October 15, 2029
      ✓ 
      Patent use: TREATMENT OF ALCOHOL DEPENDENCE

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.

Further information

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