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Generic Austedo Availability

Last updated on Sep 8, 2021.

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

AUSTEDO (deutetrabenazine - tablet;oral)

  • Manufacturer: TEVA BRANDED PHARM
    Approval date: April 3, 2017
    Strength(s): 6MG [RLD], 9MG [RLD], 12MG [RLD]

Has a generic version of Austedo been approved?

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

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

  • Patent 10,959,996

    Patent expiration dates:

    • March 7, 2036
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      Patent use: A METHOD OF TREATING HUNTINGTON'S CHOREA
  • Patent 10959996*

    Patent expiration dates:

    • September 7, 2036
  • Benzoquinoline inhibitors of vesicular monoamine transporter 2
    Patent 8,524,733
    Issued: September 3, 2013
    Assignee(s): Auspex Pharmaceuticals

    The present invention relates to new benzoquinoline inhibitors of vesicular monoamine transporter 2 (VMAT2), pharmaceutical compositions thereof, and methods of use thereof.

    Patent expiration dates:

    • April 3, 2031
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      Drug substance
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      Drug product
    • October 3, 2031
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      Pediatric exclusivity
  • Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
    Patent 9,233,959
    Issued: January 12, 2016
    Assignee(s): Auspex Pharmaceuticals, Inc.

    The present invention relates to new pharmaceutical compositions comprising benzoquinoline compounds, and methods to inhibit vesicular monoamine transporter 2 (VMAT2) activity in a subject for the treatment of chronic hyperkinetic movement disorders.

    Patent expiration dates:

    • September 18, 2033
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      Drug product
    • March 18, 2034
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      Pediatric exclusivity
  • Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
    Patent 9,296,739
    Issued: March 29, 2016
    Assignee(s): Auspex Pharmaceuticals, Inc.

    The present invention relates to new pharmaceutical compositions comprising benzoquinoline compounds, and methods to inhibit vesicular monoamine transporter 2 (VMAT2) activity in a subject for the treatment of chronic hyperkinetic movement disorders.

    Patent expiration dates:

    • September 18, 2033
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      Drug product
    • March 18, 2034
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      Pediatric exclusivity
  • Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
    Patent 9,550,780
    Issued: January 24, 2017
    Assignee(s): Auspex Pharmaceuticals, Inc.

    The present invention relates to new pharmaceutical compositions comprising benzoquinoline compounds, and methods to inhibit vesicular monoamine transporter 2 (VMAT2) activity in a subject for the treatment of chronic hyperkinetic movement disorders.

    Patent expiration dates:

    • September 18, 2033
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      Patent use: TREATMENT OF TARDIVE DYSKINESIA
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      Drug substance
      ✓ 
      Drug product
    • September 18, 2033
      ✓ 
      Patent use: A METHOD OF TREATING HUNTINGTON'S CHOREA
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • March 18, 2034
      ✓ 
      Pediatric exclusivity
  • Patent 9,814,708

    Patent expiration dates:

    • September 18, 2033
      ✓ 
      Drug product
    • March 18, 2034
      ✓ 
      Pediatric exclusivity

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:

    • April 3, 2022 - NEW CHEMICAL ENTITY
    • October 3, 2022 - PEDIATRIC EXCLUSIVITY
    • April 3, 2024 -
    • June 24, 2024 - INFORMATION FROM PEDIATRIC STUDIES ADDED TO LABEL
    • October 3, 2024 - PEDIATRIC EXCLUSIVITY
    • December 24, 2024 - 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.

Further information

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