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 ten 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. Five 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:	6

Pharmacology for NDA: 022387

Physiological Effect	Vasodilation

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:	RX	Dosage:	SOLUTION;INHALATION			Strength	0.6MG/ML
Approval Date:	Jul 30, 2009	TE:		RLD:	Yes
Patent:	10,376,525	Patent Expiration:	May 14, 2027	Product 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:	11,723,887	Patent Expiration:	Dec 15, 2028	Product Flag?		Substance Flag?	Y	Delist Request?
Patent:	11,826,327	Patent Expiration:	Feb 3, 2042	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE

Expired US Patents for NDA 022387

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
United Therap	TYVASO	treprostinil	SOLUTION;INHALATION	022387-001	Jul 30, 2009	5,153,222	⤷ Get Started Free
United Therap	TYVASO	treprostinil	SOLUTION;INHALATION	022387-001	Jul 30, 2009	6,765,117	⤷ Get Started Free
United Therap	TYVASO	treprostinil	SOLUTION;INHALATION	022387-001	Jul 30, 2009	6,756,033	⤷ Get Started Free
United Therap	TYVASO	treprostinil	SOLUTION;INHALATION	022387-001	Jul 30, 2009	6,521,212	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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