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Serving leading biopharmaceutical companies globally:

Queensland Health
Harvard Business School
Argus Health
Dow
Covington
McKinsey
Chubb
Cipla
Boehringer Ingelheim
Chinese Patent Office

Generated: November 18, 2017

DrugPatentWatch Database Preview

TYVASO Drug Profile

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Which patents cover Tyvaso, and when can generic versions of Tyvaso launch?

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

This drug has fifty-two patent family members in twelve countries.

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

Summary for TYVASO

Pharmacology for TYVASO

Ingredient-typeProstaglandins I
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation
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;INHALATION022387-001Jul 30, 2009RXYesYes► Subscribe► Subscribe ► Subscribe
United Therap
TYVASO
treprostinil
SOLUTION;INHALATION022387-001Jul 30, 2009RXYesYes► Subscribe► SubscribeY ► Subscribe
United Therap
TYVASO
treprostinil
SOLUTION;INHALATION022387-001Jul 30, 2009RXYesYes► Subscribe► SubscribeY ► Subscribe
United Therap
TYVASO
treprostinil
SOLUTION;INHALATION022387-001Jul 30, 2009RXYesYes► Subscribe► SubscribeY ► Subscribe
United Therap
TYVASO
treprostinil
SOLUTION;INHALATION022387-001Jul 30, 2009RXYesYes► Subscribe► Subscribe ► Subscribe
United Therap
TYVASO
treprostinil
SOLUTION;INHALATION022387-001Jul 30, 2009RXYesYes► Subscribe► Subscribe ► Subscribe
United Therap
TYVASO
treprostinil
SOLUTION;INHALATION022387-001Jul 30, 2009RXYesYes► Subscribe► SubscribeY ► Subscribe
United Therap
TYVASO
treprostinil
SOLUTION;INHALATION022387-001Jul 30, 2009RXYesYes► Subscribe► SubscribeY ► Subscribe
United Therap
TYVASO
treprostinil
SOLUTION;INHALATION022387-001Jul 30, 2009RXYesYes► Subscribe► Subscribe► Subscribe
United Therap
TYVASO
treprostinil
SOLUTION;INHALATION022387-001Jul 30, 2009RXYesYes► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: TYVASO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
United Therap
TYVASO
treprostinil
SOLUTION;INHALATION022387-001Jul 30, 2009► Subscribe► Subscribe
United Therap
TYVASO
treprostinil
SOLUTION;INHALATION022387-001Jul 30, 2009► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for TYVASO

Drugname Dosage Strength RLD Submissiondate
treprostinil sodiumInhalation Solution0.6 mg/mL, 2.9 mL ampulesTyvaso4/13/2015

Non-Orange Book Patents for Tradename: TYVASO

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,441,245 Process for stereoselective synthesis of prostacyclin derivatives► Subscribe
8,748,657Process to prepare treprostinil► Subscribe
8,242,305Process to prepare treprostinil, the active ingredient in remodulin► Subscribe
6,528,688 Prostacyclin derivatives► Subscribe
9,156,786Process to prepare treprostinil, the active ingredient in remodulin.RTM.► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: TYVASO

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)0054758► Subscribe
South Korea20100105852► Subscribe
Japan2009537246► Subscribe
Portugal1161234► Subscribe
Australia4082700► Subscribe
China1379665► Subscribe
Austria245628► Subscribe
Canada2365890► Subscribe
South Korea20160048222► Subscribe
Japan3717053► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

McKesson
Argus Health
Covington
Moodys
Express Scripts
Accenture
US Army
Chinese Patent Office
Baxter
Cerilliant

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 verifification 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.

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