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Generated: April 29, 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. There is one tentative approval for this compound. Additional details are available on the treprostinil profile page.

Summary for NDA: 022387


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
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
SOLUTION;INHALATION 022387 NDA United Therapeutics Corp. 66302-206 66302-206-02 1 BOX in 1 KIT (66302-206-02) > 28 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
Patent:6,765,117Patent Expiration:Oct 24, 2017Product Flag?Substance Flag?YDelist Request?
Patent:8,497,393Patent Expiration:Dec 15, 2028Product Flag?Substance Flag?YDelist Request?
Patent:9,339,507Patent Expiration:Mar 10, 2028Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022387

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
United Therap
SOLUTION;INHALATION022387-001Jul 30, 20095,153,222► Subscribe
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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 verifification 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.

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