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Last Updated: March 18, 2024

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 two NDAs. It is available from one supplier. There are eleven 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. Six 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:8
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 Corporation 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 Corporation 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
Regulatory Exclusivity Expiration:Mar 31, 2024
Regulatory Exclusivity Use:INDICATION FOR THE TREATMENT OF PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE TO IMPROVE EXERCISE ABILITY
Patent:⤷  Try a TrialPatent Expiration:May 14, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
Patent:⤷  Try a TrialPatent Expiration:May 14, 2027Product 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 ⤷  Try a Trial ⤷  Try a Trial
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 ⤷  Try a Trial ⤷  Try a Trial
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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