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TYVASO Drug Profile

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Tyvaso is a drug marketed by United Therap and is included in one NDA. It is available from one supplier. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has forty-six patent family members in twelve countries.

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

Summary for Tradename: TYVASO

Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details

Pharmacology for Tradename: TYVASO

Ingredient-typeProstaglandins I
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
United Therap
TYVASO
treprostinil
SOLUTION;INHALATION022387-001Jul 30, 2009RXYes6,521,212► subscribe ► subscribe
United Therap
TYVASO
treprostinil
SOLUTION;INHALATION022387-001Jul 30, 2009RXYes► subscribe► subscribe
United Therap
TYVASO
treprostinil
SOLUTION;INHALATION022387-001Jul 30, 2009RXYes6,765,117► subscribeY ► 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, 20095,153,222► subscribe
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Paragraph IV activity 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
9,156,786Process to prepare treprostinil, the active ingredient in remodulin.RTM.► subscribe
8,748,657Process to prepare treprostinil► 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
Austria245979► subscribe
European Patent Office2252570► subscribe
Canada2307163► 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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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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