Generic Tyvaso DPI Availability
Last updated on Dec 12, 2024.
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)
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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] -
Manufacturer: UNITED THERAP
Approval date: October 24, 2024
Strength(s): 0.08MG/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.
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Diketopiperazine salts for drug delivery and related methods
Patent 10,130,685
Issued: November 20, 2018
Inventor(s): Leone-Bay Andrea & Moye-Sherman Destardi & Wilson Bryan R.
Assignee(s): MannKind CorporationDrug delivery systems have been developed based on the formation of diketopiperazine carboxylate salts and microparticles containing the same. The systems may further comprise a bioactive agent. Related methods for making and using the biologically active agent delivery compositions are also provided. In certain embodiments, the pharmaceutically acceptable salts described can be formed by removal of solvent by methods including distillation, evaporation, spray drying or lyophilization.
Patent expiration dates:
- August 23, 2025✓
- August 23, 2025
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Microcrystalline diketopiperazine compositions and methods
Patent 10,421,729
Issued: September 24, 2019
Inventor(s): Wilson Bryan R. & Guarneri Joseph J. & Grant Marshall L.
Assignee(s): MannKind CorporationDisclosed herein are DKP microcrystals made by an improved method where they do not irreversibly self-assemble into microparticles. The microcrystals can be dispersed by atomization and re-formed by spray drying into particles having spherical shell morphology. Active agents and excipients can be incorporated into the particles by spray drying a solution containing the components to be incorporated into microcrystalline diketopiperazine particles. In particular, the microcrystalline particle compositions are suitable for pulmonary drug delivery of one or more peptides, proteins, nucleic acids and/or small organic molecules.
Patent expiration dates:
- April 1, 2035✓
- April 1, 2035
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Treprostinil administration by inhalation
Patent 10,716,793
Issued: July 21, 2020
Inventor(s): Olschewski Horst & Roscigno Robert & Rubin Lewis J. & Schmehl Thomas & Seeger Werner & Sterritt Carl & Voswinckel Robert
Assignee(s): United Therapeutics CorporationTreprostinil can be administered using a metered dose inhaler. Such administration provides a greater degree of autonomy to patients. Also disclosed are kits that include a metered dose inhaler containing a pharmaceutical formulation containing treprostinil.
Patent expiration dates:
- May 14, 2027✓✓
- May 14, 2027
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Diketopiperazine microparticles with defined specific surface areas
Patent 10,772,883
Issued: September 15, 2020
Inventor(s): Grant Marshall L. & Stowell Grayson W. & Menkin Paul & Freeman & Jr. John J.
Assignee(s): MannKind CorporationDisclosed herein are diketopiperazine microparticles having a specific surface area of less than about 67 m/g. The diketopiperazine microparticle can be fumaryl diketopiperazine and can comprise a drug such as insulin.
Patent expiration dates:
- June 11, 2030✓
- June 11, 2030
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Patent 11,723,887
Patent expiration dates:
- December 15, 2028✓
- December 15, 2028
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Patent 11,826,327
Patent expiration dates:
- February 3, 2042✓
- February 3, 2042
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Process to prepare treprostinil, the active ingredient in remodulin®
Patent 9,593,066
Issued: March 14, 2017
Inventor(s): Batra Hitesh & Tuladhar Sudersan M. & Penmasta Raju & Walsh David A.
Assignee(s): United Therapeutics CorporationThis present invention relates to an improved process to prepare prostacyclin derivatives. One embodiment provides for an improved process to convert benzindene triol to treprostinil via salts of treprostinil and to purify treprostinil.
Patent expiration dates:
- December 15, 2028✓
- December 15, 2028
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 23, 2025 - NEW PRODUCT
More about Tyvaso DPI (treprostinil)
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- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: agents for pulmonary hypertension
- Breastfeeding
Patient resources
- Tyvaso DPI Maintenance Kit inhalation drug information
- Tyvaso DPI Titration Kit inhalation
- Tyvaso DPI (Advanced Reading)
Other brands
Professional resources
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Related treatment guides
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.