Details for New Drug Application (NDA): 214324

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NDA 214324 describes TYVASO DPI, which 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. Additional details are available on the TYVASO DPI profile page.

The generic ingredient in TYVASO DPI 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 214324

Tradename:	TYVASO DPI
Applicant:	United Therap
Ingredient:	treprostinil
Patents:	6

Pharmacology for NDA: 214324

Physiological Effect	Vasodilation

Suppliers and Packaging for NDA: 214324

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TYVASO DPI	treprostinil	POWDER;INHALATION	214324	NDA	United Therapeutics Corporation	66302-610	66302-610-02	1 KIT in 1 PACKAGE (66302-610-02) * 4 INHALANT in 1 BLISTER PACK * 4 INHALANT in 1 BLISTER PACK * 4 INHALANT in 1 BLISTER PACK
TYVASO DPI	treprostinil	POWDER;INHALATION	214324	NDA	United Therapeutics Corporation	66302-616	66302-616-03	4 BLISTER PACK in 1 KIT (66302-616-03) / 7 BLISTER PACK in 1 BLISTER PACK / 4 INHALANT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INHALATION			Strength	0.016MG/INH
Approval Date:	May 23, 2022	TE:		RLD:	Yes
Patent:	⤷ Get Started Free	Patent Expiration:	Apr 1, 2035	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Get Started Free	Patent Expiration:	Jun 11, 2030	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Get Started Free	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

Expired US Patents for NDA 214324

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-001	May 23, 2022	⤷ Get Started Free	⤷ Get Started Free
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-004	May 23, 2022	⤷ Get Started Free	⤷ Get Started Free
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-005	Oct 24, 2024	⤷ Get Started Free	⤷ Get Started Free
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-002	May 23, 2022	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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