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Serving leading biopharmaceutical companies globally:

US Army
Boehringer Ingelheim
Moodys
Cerilliant
Julphar
Johnson and Johnson
AstraZeneca
Novartis
Fish and Richardson
McKesson

Generated: January 22, 2018

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 sixteen 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
International Patents:52
US Patents:8
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 19
Clinical Trials: 14
Patent Applications: 153
Drug Prices:see details
DailyMed Link:TYVASO at DailyMed
Drug patent expirations by year for TYVASO
Pharmacology for TYVASO
Ingredient-typeProstaglandins I
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation

US Patents and Regulatory Information for TYVASO

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 ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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

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Paragraph IV (Patent) Challenges for TYVASO
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Inhalation Solution 0.6 mg/mL, 2.9 mL ampules ➤ Subscribe 4/13/2015

Non-Orange Book US Patents for 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
9,156,786 Process to prepare treprostinil, the active ingredient in remodulin.RTM. ➤ Subscribe
6,528,688 Prostacyclin derivatives ➤ Subscribe
8,242,305 Process to prepare treprostinil, the active ingredient in remodulin ➤ Subscribe
8,748,657 Process to prepare treprostinil ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for TYVASO

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Serving leading biopharmaceutical companies globally:

Merck
Argus Health
QuintilesIMS
Farmers Insurance
McKinsey
Medtronic
Mallinckrodt
Novartis
Moodys

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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