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Generated: April 18, 2019

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Details for New Drug Application (NDA): 022387

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NDA 022387 describes TYVASO, which is a drug marketed by United Therap and is included in one NDA. It is available from one supplier. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TYVASO profile page.

The generic ingredient in TYVASO is treprostinil. There are nineteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the treprostinil profile page.
Summary for 022387
Tradename:TYVASO
Applicant:United Therap
Ingredient:treprostinil
Patents:5
Pharmacology for NDA: 022387
Physiological EffectVasodilation
Suppliers and Packaging for NDA: 022387
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TYVASO treprostinil SOLUTION;INHALATION 022387 NDA United Therapeutics Corp. 66302-206 66302-206-01 1 BOX in 1 KIT (66302-206-01) > 28 AMPULE in 1 BOX > 2.9 mL in 1 AMPULE
TYVASO treprostinil SOLUTION;INHALATION 022387 NDA United Therapeutics Corp. 66302-206 66302-206-02 1 BOX in 1 KIT (66302-206-02) > 28 AMPULE in 1 BOX > 2.9 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrength0.6MG/ML
Approval Date:Jul 30, 2009TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Dec 15, 2028Product Flag?Substance Flag?YDelist Request?Y
Patent:➤ Sign UpPatent Expiration:Mar 10, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:May 5, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE

Expired US Patents for NDA 022387

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

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
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Fish and Richardson
Citi
US Army
Harvard Business School

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