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 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
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:	⤷ Sign Up	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:	⤷ Sign Up	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 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	⤷ 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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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 verification 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.