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Generic Vyndaqel Availability

Medically reviewed by Drugs.com. Last updated on May 11, 2021.

See also: Generic Vyndamax

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

VYNDAQEL (tafamidis meglumine - capsule;oral)

  • Manufacturer: FOLDRX PHARMS
    Approval date: May 3, 2019
    Strength(s): 20MG [RLD]

Has a generic version of Vyndaqel been approved?

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

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

  • Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding
    Patent 7,214,695
    Issued: May 8, 2007
    Inventor(s): Kelly; Jeffery W. & Powers; Evan T. & Razavi; Hossein
    Assignee(s): The Scripps Research Institute

    Kinetic stabilization of the native state of transthyretin is an effective mechanism for preventing protein misfolding. Because transthyretin misfolding plays an important role in transthyretin amyloid diseases, inhibiting such misfolding can be used as an effective treatment or prophylaxis for such diseases. Treatment methods, screening methods, as well as specific transthyretin stabilizing compounds are disclosed.

    Patent expiration dates:

    • April 27, 2024
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      Drug substance
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      Drug product
  • Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding
    Patent 7,214,696
    Issued: May 8, 2007
    Inventor(s): Kelly; Jeffery W. & Sekijima; Yoshiki
    Assignee(s): The Scripps Research Institute

    Kinetic stabilization of the native state of transthyretin is an effective mechanism for preventing protein misfolding. Because transthyretin misfolding plays an important role in transthyretin amyloid diseases, inhibiting such misfolding can be used as an effective treatment or prophylaxis for such diseases. Treatment methods, screening methods, as well as specific transthyretin stabilizing compounds are disclosed.

    Patent expiration dates:

    • December 19, 2023
      ✓ 
      Patent use: TREATMENT OF THE CARDIOMYOPATHY OF WILD TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM)
  • Pharmaceutically acceptable salt of 6-carboxy-2-(3,5 dichlorophenyl)-benzoxazole, and a pharmaceutical composition comprising the salt thereof
    Patent 8,168,663
    Issued: May 1, 2012
    Inventor(s): Kelly; Jeffery W. & Powers; Evan T. & Razavi; Hossein
    Assignee(s): The Scripps Research Institute

    Kinetic stabilization of the native state of transthyretin is an effective mechanism for preventing protein misfolding. Because transthyretin misfolding plays an important role in transthyretin amyloid diseases, inhibiting such misfolding can be used as an effective treatment or prophylaxis for such diseases. Treatment methods are disclosed.

    Patent expiration dates:

    • December 19, 2023
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      Drug substance
      ✓ 
      Drug product
  • Methods for treating transthyretin amyloid diseases
    Patent 8,653,119
    Issued: February 18, 2014
    Assignee(s): The Scripps Research Institute

    Kinetic stabilization of the native state of transthyretin is an effective mechanism for preventing protein misfolding. Because transthyretin misfolding plays an important role in transthyretin amyloid diseases, inhibiting such misfolding can be used as an effective treatment or prophylaxis for such diseases. Treatment methods are disclosed.

    Patent expiration dates:

    • January 28, 2024
      ✓ 
      Patent use: TREATMENT OF THE CARDIOMYOPATHY OF WILD TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM)

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:

    • May 3, 2024 - NEW CHEMICAL ENTITY
    • May 3, 2026 -

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.