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Generic Tyvaso DPI Availability

Last updated on Sep 6, 2023.

See also: Generic Tyvaso

Tyvaso DPI is a brand name of treprostinil, approved by the FDA in the following formulation(s):

TYVASO DPI (treprostinil - powder;inhalation)

  • Manufacturer: UNITED THERAP
    Approval date: May 23, 2022
    Strength(s): 0.016MG/INH [RLD], 0.032MG/INH [RLD], 0.048MG/INH [RLD], 0.064MG/INH [RLD]

Has a generic version of Tyvaso DPI been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Tyvaso DPI. 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 10,130,685

    Patent expiration dates:

    • August 23, 2025
      ✓ 
      Drug product
  • Patent 10,421,729

    Patent expiration dates:

    • April 1, 2035
      ✓ 
      Drug product
  • Patent 10,716,793

    Patent expiration dates:

    • May 14, 2027
      ✓ 
      Patent use: METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
  • Patent 10,772,883

    Patent expiration dates:

    • June 11, 2030
      ✓ 
      Drug product
  • Patent 11,723,887

    Patent expiration dates:

    • December 15, 2028
      ✓ 
      Drug substance
  • Patent 9,593,066

    Patent expiration dates:

    • December 15, 2028
      ✓ 
      Drug substance
  • Patent 9,604,901

    Patent expiration dates:

    • December 15, 2028
      ✓ 
      Drug substance

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.

Medical Disclaimer