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Last Updated: April 26, 2024

TYVASO DPI Drug Patent Profile


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When do Tyvaso Dpi patents expire, and what generic alternatives are available?

Tyvaso Dpi is a drug marketed by United Therap and is included in one NDA. There are eight patents protecting this drug.

This drug has one hundred and thirty-nine patent family members in twenty countries.

The generic ingredient in TYVASO DPI is treprostinil. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the treprostinil profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Tyvaso Dpi

A generic version of TYVASO DPI was approved as treprostinil by SANDOZ on November 30th, 2017.

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Summary for TYVASO DPI
Drug patent expirations by year for TYVASO DPI
Drug Prices for TYVASO DPI

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Recent Clinical Trials for TYVASO DPI

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SponsorPhase
United TherapeuticsPhase 1
Bastiaan DriehuysPhase 2
Children's Hospital Medical Center, CincinnatiPhase 2

See all TYVASO DPI clinical trials

Pharmacology for TYVASO DPI
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation

US Patents and Regulatory Information for TYVASO DPI

TYVASO DPI is protected by eight US patents.

Patents protecting TYVASO DPI

Diketopiperazine salts for drug delivery and related methods
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Patent Expiration: ⤷  Try a Trial

Microcrystalline diketopiperazine compositions and methods
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Patent Expiration: ⤷  Try a Trial

Treprostinil administration by inhalation
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE

Diketopiperazine microparticles with defined specific surface areas
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE

Process to prepare treprostinil, the active ingredient in remodulin.RTM.
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Patent Expiration: ⤷  Try a Trial

Process to prepare treprostinil, the active ingredient in Remodulin.RTM.
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Patent Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
United Therap TYVASO DPI treprostinil POWDER;INHALATION 214324-004 May 23, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
United Therap TYVASO DPI treprostinil POWDER;INHALATION 214324-004 May 23, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
United Therap TYVASO DPI treprostinil POWDER;INHALATION 214324-004 May 23, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
United Therap TYVASO DPI treprostinil POWDER;INHALATION 214324-001 May 23, 2022 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
United Therap TYVASO DPI treprostinil POWDER;INHALATION 214324-003 May 23, 2022 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for TYVASO DPI

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
SciPharm Sàrl Trepulmix treprostinil EMEA/H/C/005207
Treatment of adult patients with WHO Functional Class (FC) III or IV and:inoperable chronic thromboembolic pulmonary hypertension (CTEPH), orpersistent or recurrent CTEPH after surgical treatmentto improve exercise capacity.
Authorised no no yes 2020-04-03
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for TYVASO DPI

See the table below for patents covering TYVASO DPI around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 2970149 COMPOSITIONS DE DICÉTOPIPÉRAZINE MICROCRISTALLINES ET PROCÉDÉS (MICROCRYSTALLINE DIKETOPIPERAZINE COMPOSITIONS AND METHODS) ⤷  Try a Trial
Australia 2020200744 MICROCRYSTALLINE DIKETOPIPERAZINE COMPOSITIONS AND METHODS ⤷  Try a Trial
Hong Kong 1219097 微晶二酮哌嗪組合物以及方法 (MICROCRYSTALLINE DIKETOPIPERAZINE COMPOSITIONS AND METHODS) ⤷  Try a Trial
Hungary E026134 ⤷  Try a Trial
Canada 2654492 ADMINISTRATION DE TREPROSTINIL UTILISANT UN INHALATEUR A DOSE MESUREE (TREPROSTINIL ADMINISTRATION USING A METERED DOSE INHALER) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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