Generic Nuedexta Availability

Nuedexta is a brand name of dextromethorphan/quinidine, approved by the FDA in the following formulation(s):

NUEDEXTA (dextromethorphan hydrobromide; quinidine sulfate - capsule;oral)

  • Manufacturer: AVANIR PHARMS
    Approval date: October 29, 2010
    Strength(s): 20MG;10MG [RLD]

Has a generic version of Nuedexta been approved?

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

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

  • Pharmaceutical compositions comprising dextromethorphan and quinidine for the treatment of neurological disorders
    Patent 7,659,282
    Issued: February 9, 2010
    Inventor(s): Yakatan; Gerald & Berg; James & Pope; Laura E. & Smith; Richard A.
    Assignee(s): Avanir Pharmaceuticals, Inc.
    Pharmaceutical compositions and methods for treating neurological disorders by administering same are provided. The compositions comprise dextromethorphan in combination with quinidine.
    Patent expiration dates:
    • August 13, 2026
      ✓ 
      Patent use: TREATMENT OF PSEUDOBULBAR AFFECT
  • Pharmaceutical compositions comprising dextromethorphan and quinidine for the treatment of neurological disorders
    Patent 8,227,484
    Issued: July 24, 2012
    Inventor(s): Yakatan; Gerald & Berg; James & Pope; Laura & Smith; Richard Alan
    Assignee(s): Avanir Pharmaceuticals, Inc.
    Pharmaceutical compositions and methods for treating neurological disorders by administering same are provided. The compositions comprise dextromethorphan in combination with quinidine.
    Patent expiration dates:
    • July 17, 2023
      ✓ 
      Patent use: TREATMENT OF PSEUDOBULBAR AFFECT
  • Dextromethorphan and an oxidase inhibitor for treating intractable conditions
    Patent RE38115
    Issued: May 6, 2003
    Inventor(s): Richard Alan; Smith & Jonathan M.; Licht
    Assignee(s): Center for Neurologic Study
    Methods are disclosed for increasing the effectiveness of dextromethorphan in treating chronic or intractable pain, for treating tinnitus and for treating sexual dysfunction comprising administering dextromethorphan in combination with a therapeutically effective dosage of a debrisoquin hydroxylase inhibitor. A preferred combination is dextromethorphan and the oxidative inhibitor quinidine.
    Patent expiration dates:
    • January 26, 2016
      ✓ 
      Drug product

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 29, 2013 - NEW COMBINATION

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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