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Details for New Drug Application (NDA): 203496

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NDA 203496 describes ORENITRAM, which is a drug marketed by United Therap and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ORENITRAM profile page.

The generic ingredient in ORENITRAM is treprostinil diolamine. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the treprostinil diolamine profile page.

Summary for NDA: 203496

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

Pharmacology for NDA: 203496

Ingredient-typeProstaglandins I
Physiological EffectVasodilation

Suppliers and Packaging for NDA: 203496

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL 203496 NDA United Therapeutics Corp. 66302-300 66302-300-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (66302-300-01)
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL 203496 NDA United Therapeutics Corp. 66302-300 66302-300-10 10 TABLET, EXTENDED RELEASE in 1 BOTTLE (66302-300-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 0.125MG BASE
Approval Date:Dec 20, 2013TE:RLD:Yes
Patent:6,765,117Patent Expiration:Oct 24, 2017Product Flag?Substance Flag?YDelist Request?
Patent:7,417,070Patent Expiration:Jul 30, 2026Product Flag?Substance Flag?YDelist Request?
Patent:8,252,839Patent Expiration:May 24, 2024Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 203496

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-001Dec 20, 20135,153,222► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-002Dec 20, 20135,153,222► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-003Dec 20, 20135,153,222► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-004Dec 20, 20135,153,222► 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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