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Generated: December 12, 2017

DrugPatentWatch Database Preview

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 eight 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 fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the treprostinil profile page.

Summary for 022387

Tradename:1
Applicant:1
Ingredient:1
Patents:8

Pharmacology for NDA: 022387

Ingredient-typeProstaglandins I
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 66302-206-04 1 BOX in 1 KIT (66302-206-04) > 4 AMPULE in 1 BOX > 2.9 mL in 1 AMPULE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrength0.6MG/ML
Approval Date:Jul 30, 2009TE:RLD:Yes
Regulatory Exclusivity Expiration:May 20, 2017
Regulatory Exclusivity Use:ADDITION OF INFORMATION ABOUT LONG-TERM TREATMENT OF PULMONARY ARTERIAL HYPERTENSION TO THE CLINICAL STUDIES SECTION OF THE LABELING
Regulatory Exclusivity Expiration:Jul 30, 2016
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:► SubscribePatent Expiration:Nov 13, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PULMONARY HYPERTENSION BY INHALATION

Expired Orange Book Patents for NDA: 022387

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
United TherapTYVASOtreprostinilSOLUTION;INHALATION022387-001Jul 30, 2009► Subscribe► Subscribe
United TherapTYVASOtreprostinilSOLUTION;INHALATION022387-001Jul 30, 2009► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Boehringer Ingelheim
Healthtrust
Novartis
Chinese Patent Office
Fuji
Farmers Insurance
Colorcon
AstraZeneca
Accenture

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