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 forty 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 30^th, 2017.

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Summary for TYVASO DPI

International Patents:	140
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	23
Drug Prices:	Drug price information for TYVASO DPI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TYVASO DPI
What excipients (inactive ingredients) are in TYVASO DPI?	TYVASO DPI excipients list
DailyMed Link:	TYVASO DPI at DailyMed

Drug patent expirations by year for TYVASO DPI

Recent Clinical Trials for TYVASO DPI

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

Sponsor	Phase
United Therapeutics	Phase 1
Bastiaan Driehuys	Phase 2
Children's Hospital Medical Center, Cincinnati	Phase 2

See all TYVASO DPI clinical trials

Pharmacology for TYVASO DPI

Drug Class	Prostacycline Vasodilator
Physiological Effect	Vasodilation

US Patents and Regulatory Information for TYVASO DPI

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

Patents protecting TYVASO DPI

Diketopiperazine salts for drug delivery and related methods
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Microcrystalline diketopiperazine compositions and methods
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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

Diketopiperazine microparticles with defined specific surface areas
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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

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 DPI

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Glossary

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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	214324-004	May 23, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
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	214324-004	May 23, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-001	May 23, 2022		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-002	May 23, 2022		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-003	May 23, 2022		RX	Yes	No	⤷ Sign Up	⤷ Sign Up		Y	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

EU/EMA Drug Approvals for TYVASO DPI

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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.

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Country	Patent Number	Title	Estimated Expiration
South Korea	102391750		⤷ Sign Up
South Korea	20220057646	미세결정성 디케토피페라진 조성물 및 방법 (MICROCRYSTALLINE DIKETOPIPERAZINE COMPOSITIONS AND METHODS)	⤷ Sign Up
Japan	2023115244	薬物送達システム (DRUG DELIVERY SYSTEM)	⤷ Sign Up
Japan	2019112434	定量吸入器を用いたトレプロスチニル投与 (TREPROSTINIL ADMINISTRATION USING METERED DOSE INHALER)	⤷ Sign Up
South Korea	20140069314	DIKETOPIPERAZINE SALTS, DIKETOMORPHOLINE SALTS OR DIKETODIOXANE SALTS FOR DRUG DELIVERY	⤷ Sign Up
Japan	2022100411	微結晶性ジケトピペラジン粒子の製造方法	⤷ Sign Up
European Patent Office	2026816	ADMINISTRATION DE TREPROSTINIL UTILISANT UN INHALATEUR À DOSE MESURÉE (TREPROSTINIL ADMINISTRATION USING A METERED DOSE INHALER)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration