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Last Updated: May 19, 2022

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 one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-seven patent family members in seven countries.

The generic ingredient in TYVASO is treprostinil. There are nineteen drug master file entries for this compound. Five 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 INC on November 30th, 2017.

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Drug patent expirations by year for TYVASO
Drug Prices for TYVASO

See drug prices for TYVASO

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 Effect Vasodilation
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 six US patents and one FDA Regulatory Exclusivity.

Patents protecting TYVASO

Treprostinil administration by inhalation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE

Treprostinil administration by inhalation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE

Treprostinil administration by inhalation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Treprostinil administration by inhalation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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.
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Process to prepare treprostinil, the active ingredient in Remodulin.RTM.
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting TYVASO

INDICATION FOR THE TREATMENT OF PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE TO IMPROVE EXERCISE ABILITY
Exclusivity Expiration: See Plans and Pricing

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 treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 See Plans and Pricing See Plans and Pricing
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 See Plans and Pricing See Plans and Pricing
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for TYVASO

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

Country Patent Number Title Estimated Expiration
China 1264819 See Plans and Pricing
Canada 2710205 PROCEDE AMELIORE DE PREPARATION DE TREPROSTINIL, L'INGREDIENT ACTIF DANS LE REMODULIN (AN IMPROVED PROCESS TO PREPARE TREPROSTINIL, THE ACTIVE INGREDIENT IN REMODULIN) See Plans and Pricing
Germany 60004181 See Plans and Pricing
Austria 245628 See Plans and Pricing
South Korea 20090007797 TREPROSTINIL ADMINISTRATION USING A METERED DOSE INHALER See Plans and Pricing
China 101495122 Treprostinil administration using a metered dose inhaler See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
Express Scripts
McKinsey
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Dow
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.