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Last Updated: July 20, 2024

TYVASO Drug Patent Profile


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Which patents cover Tyvaso, and what generic alternatives are available?

Tyvaso is a drug marketed by United Therap and is included in two NDAs. There are eleven patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-five patent family members in nine countries.

The generic ingredient in TYVASO 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

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

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Drug patent expirations by year for TYVASO
Drug Prices for TYVASO

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Recent Clinical Trials for TYVASO

Identify potential brand extensions & 505(b)(2) entrants

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

See all TYVASO clinical trials

Pharmacology for TYVASO
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation
Paragraph IV (Patent) Challenges for TYVASO
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TYVASO Inhalation Solution treprostinil 0.6 mg/mL, 2.9 mL ampules 022387 1 2015-04-13

US Patents and Regulatory Information for TYVASO

TYVASO is protected by eight US patents and one FDA Regulatory Exclusivity.

Patents protecting TYVASO

Treprostinil administration by inhalation
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Patented Use: METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE

Treprostinil administration by inhalation
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Patented Use: METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE


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Patented Use: METHOD OF TREATING PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE

Treprostinil administration by inhalation
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Treprostinil administration by inhalation
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Patented Use: METHOD OF TREATING PULMONARY HYPERTENSION 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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Process to prepare treprostinil, the active ingredient in Remodulin.RTM.
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FDA Regulatory Exclusivity protecting TYVASO

INDICATION FOR THE TREATMENT OF PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE TO IMPROVE EXERCISE ABILITY
Exclusivity Expiration: ⤷  Sign Up

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

Expired US Patents for TYVASO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 ⤷  Sign Up ⤷  Sign Up
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 ⤷  Sign Up ⤷  Sign Up
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 ⤷  Sign Up ⤷  Sign Up
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for TYVASO

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

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

Country Patent Number Title Estimated Expiration
China 1379665 ⤷  Sign Up
Canada 2307163 PROCEDE DE SYNTHESE STEREOSELECTIVE DE DERIVES DE LA PROSTACYCLINE (PROCESS FOR STEREOSELECTIVE SYNTHESIS OF PROSTACYCLIN DERIVATIVES) ⤷  Sign Up
Canada 1327524 PROSTAGLANDINES ENTRANT DANS LA COMPOSITION D'UN MEDICAMENT (PROSTAGLANDINS FOR USE IN MEDICINE) ⤷  Sign Up
China 101903324 Process to prepare treprostinil, the active ingredient in Remodulin ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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